Safe and Effective Prescribing of Controlled Substances Nursing CE Course for APRNs

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Safe and Effective Prescribing of Controlled Substances (for APRNs)

Disclosure Statement

The purpose of this course is to discuss the basic safety guidelines that must be observed by advanced practice registered nurses (APRNs) who are prescribing controlled substances. This course satisfies the specific requirements for three (3) hours of continuing professional development for advanced nurse prescribers in Florida and New York.

By the end of this module, the APRN should be able to:

• describe the epidemiology of substance use disorder (SUD)
• discuss the three different classes of controlled substances most commonly misused: indications, risks, benefits, common adverse effects, and alternatives for opioids, central nervous system (CNS) depressants, and stimulants
• define medication tolerance, dependence, and addiction
• highlight the evidence-based guidelines for safe prescribing practices
• discuss pain management, including both acute and chronic pain, and special considerations for controlled substance use in older adults and pregnant patients
• review the special circumstances involved in palliative medicine and end-of-life care
• explore the prevention, screening, and signs of potential SUD and addiction
• describe the appropriate response to and current treatment options for SUD and addiction
• review the New York State and federal requirements for prescribing controlled substances
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The Epidemiology of the Misuse of Controlled Substances

According to the 2024 National Survey on Drug Use and Health conducted by the US Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA, 2025a), of the 73.6 million people aged 12 and older who used illicit drugs in the past year, 13.8 million of them misused psychotherapeutic drugs. This includes drugs currently or recently available by prescription in the United States, and includes pain relievers, stimulants, and tranquilizers or sedatives. Of these 13.8 million people, 7.6 million misused prescription opioids, 4.6 million misused tranquilizers or sedatives, and 3.9 million misused stimulants. The percentage of people aged 12 and older who misused prescription pain relievers in 2024 (2.8%) was unchanged from the 2021 report. Of those who misused pain medications in the last year, 70.1% report that they misused them due to physical pain; 42.3% obtained the last medications they used from a relative or friend, and 40.5% acquired them through a valid prescription written by one provider. The most commonly misused medications were hydrocodone products (SAMHSA, 2025a). The Centers for Disease Control and Prevention (CDC, 2026) estimates that of the 105,000 people who died from drug overdose in the United States in 2023, 73% involved an opioid. According to the US Drug Enforcement Administration (DEA, 2022), APRNs are authorized to prescribe controlled substances in schedules II–V in many US states; however, schedule II prescribing authority is subject to state-specific limitations regarding conditions or quantity.

Controlled Substances: The Basics

Controlled substances are classified according to categories or “schedules” based on the perceived risk of addiction as outlined by the DEA. Schedule I drugs, substances, and chemicals are not acceptable for medical use and have the highest potential for misuse. Examples of these include heroin and marijuana. Schedule II drugs, substances, and chemicals have a high potential for misuse and dependence. Examples include methadone (Methadose), hydromorphone (Dilaudid), amphetamine-dextroamphetamine (Adderall), and methylphenidate (Ritalin). Schedule III drugs, substances, and chemicals have moderate to low abuse and dependence potential. These include Tylenol with codeine (Tylenol #3) and ketamine (Ketalar). Schedule IV drugs, substances, and chemicals have low potential for misuse and dependence. These include tramadol (Ultram), alprazolam (Xanax), lorazepam (Ativan), and zolpidem (Ambien). Schedule V drugs, substances, and chemicals have the lowest potential for abuse and include codeine/guaifenesin (Robitussin AC) and pregabalin (Lyrica; DEA, n.d.).

The three categories of controlled substances that are most commonly misused include opioids, sedatives or tranquilizers, and stimulants (SAMHSA, 2025a). Opioids are CNS depressants usually prescribed for pain control and function as opioid agonists, binding to mu-opioid receptors in the brain to reduce or block the pain signal to the brain. They also affect receptors in the respiratory and gastrointestinal (GI) tract and are occasionally used to treat diarrhea and cough. Most opioids also decrease gamma-aminobutyric acid (GABA) levels and thus increase dopamine as a component of their analgesia, affecting the experience of pleasure/reward and leading to addiction-related concerns. Tramadol (Ultram) is a schedule IV synthetic opioid commonly used to treat mild to moderate pain. Codeine (Tylenol #3) is frequently prescribed to treat mild to moderate pain or cough, alone or combined with acetaminophen in cough and cold formulas. According to the US Department of Health and Human Services (HHS, 2019b), the most common opioid agonists prescribed for moderate or severe pain include:

• hydrocodone (Vicodin, Lortab, Norco)—a schedule II drug found most commonly in combination products (e.g., combined with acetaminophen or an antihistamine); it may be an oral tablet formulation or oral solution/suspension
• oxycodone (Roxicodone, OxyContin)—a schedule II drug available as a rapid-onset immediate-release (IR) tablet or solution or extended-release (ER) formula in oral tablet or capsule form
• morphine sulfate (Roxanol, MS Contin)—a schedule II drug available as an IR or ER oral formula and an IR parenteral formula
• oxymorphone (Opana, Opana ER)—a schedule II drug available as an IR or ER formula

• hydromorphone (Dilaudid, Exalgo ER)—a schedule II drug derived from morphine but with greater potency; it is available as an oral tablet, oral liquid, rectal suppository, and parental IR formula, as well as oral ER formula (HHS, 2019b; Rosenquist, 2026)

They may be naturally occurring alkaloids (derived from the opium poppy plant), synthetic (human-made), or semisynthetic. These and other common types of opioid agonists are listed in Table 1.

Table 1

Opioid Agonists

(CDC, 2024a; Seligman et al., 2026)

Adverse reactions to opioid use include respiratory depression, drowsiness, mental confusion, nausea/vomiting, dizziness, headache, fatigue, pruritus, pinpoint pupils, urinary retention, and constipation. Since these agents can induce euphoria, especially when taken in higher doses than prescribed or ingested via snorting or injection, they pose a high risk for misuse and addiction. Long-term use of these drugs can also carry the added risk of drug tolerance and hyperalgesia (i.e., increased sensitivity to pain caused by damage to nociceptors or peripheral nerves; Rosenquist, 2026; Stolbach & Hoffman, 2026; Strain, 2026a).

Tranquilizers and sedatives are CNS depressants for treating conditions such as anxiety and sleep disorders. Most CNS depressants increase the activity of the neurotransmitter GABA, inhibiting overall brain activity and producing a sedating or calming effect (Goldschen-Ohm, 2022). This class includes benzodiazepines (BZDs), such as diazepam (Valium), clonazepam (Klonopin), alprazolam (Xanax), triazolam (Halcion), and estazolam (ProSom). They are typically categorized as schedule IV medications and used to treat generalized anxiety disorder (GAD) as well as panic attacks, acute stress reactions, and occasionally muscle spasms (diazepam [Valium]), seizure disorders (clonazepam [Klonopin]), or sleep disorders (triazolam [Halcion] or estazolam [Prosom]). This group of medications should be used cautiously and only briefly due to a high risk of tolerance, dependence, and addiction (Neubauer, 2026; Schachter & Sirven, 2026; Stein & Craske, 2026). Prescribers should be particularly cautious when considering the potential risks and benefits of concurrent use of BZDs and opioid pain medications due to the additive sedating effects of these two groups of medication (Dowell et al., 2022). Barbiturates, such as mephobarbital (Mebaral), phenobarbital (Luminal), and pentobarbital (Nembutal), are less commonly used medications for anxiety and sleep disorders due to their high risk of potential addiction or overdose. They are still used in seizure disorders and in limited neurologic or specialty settings (Schachter & Sirven, 2026). All CNS depressants can cause drowsiness, confusion, and poor coordination. Chronic BZD or barbiturate therapy should never be stopped abruptly but tapered off slowly due to the risk of withdrawal symptoms, seizures, or other harmful effects. Barbiturate withdrawal can be especially dangerous and potentially life-threatening (Neubauer, 2026; Schachter & Sirven, 2026; Stein & Craske, 2026).

Prescription stimulants such as dextroamphetamine (Dexedrine, Adderall) and methylphenidate (Ritalin, Concerta) may be used to treat conditions such as attention-deficit hyperactivity disorder (ADHD), narcolepsy (a sleep disorder), augmentation in treatment-resistant depression (off-label), and chronic diseases that cause fatigue, such as multiple sclerosis (MS; off-label). They improve alertness, attention, and energy level by enhancing the effects of norepinephrine and dopamine in the brain. Adverse effects include tachycardia and hypertension. Stimulants were historically used for several other conditions, but this use was curtailed as the risk for addiction became evident. The systemic effects of norepinephrine include hypertension, tachycardia, constriction of blood vessels, increased blood glucose, and bronchodilation. The public perception of these medications as relatively safe has likely contributed to their misuse in the last two decades. When augmented, dopamine enhancement can result in a feeling of euphoria. Patients and their caregivers/parents should be adequately educated regarding the potential risks of nonprescription drug use, such as unsafe driving, unsafe sexual activities, and progression to illicit substances. They are often used for nonmedical purposes to enhance mental performance. Repeated misuse of stimulants has been linked to feelings of hostility, paranoia, and psychosis, and overdose can lead to hyperthermia, arrhythmias, cardiovascular arrest, or seizures. Due to the seriousness of these medications’ risks, they are classified as schedule II (CDC, 2025b; DEA, 2024; Kampman, 2026). Children and adolescents with ADHD have higher rates of risky behaviors and comorbid conditions, but treating ADHD symptoms can reduce some of these risks (Chan, 2026). Modafinil (Provigil) is a stimulant indicated to treat narcolepsy, obstructive sleep apnea-related excessive daytime sleepiness, and shift work sleep disorder, which works by indirectly affecting dopamine and other arousal systems. Therefore, it has a slightly safer profile and is categorized as schedule IV (UpToDate Lexidrug, n.d.-b).

Tolerance, Dependence, and Addiction—What Is the Difference?

The CDC (2024a) defines tolerance to medication as the gradual need for an increased dose of a particular medication over time to obtain a similar effect. The development of tolerance varies significantly from individual to individual and from medication to medication; it is due to the brain’s ability to adapt to its environment physically. Tolerance is not limited to pain management or illicit drugs but is also seen in other specialties (e.g., some antihypertensives lose their potency over time) and circumstances. Physical dependence is the physiological adaptation to a medication that develops with consistent and regular use and is a component of addiction. The medication becomes necessary for normal homeostasis and functioning. This phenomenon typically correlates with opposing withdrawal symptoms if that medication is stopped. Addiction is a combination of physical dependence and compulsive drug-seeking behaviors despite significant negative repercussions. Misuse of prescription drugs is ingesting or utilizing these medications in a manner, a dose, or by an individual other than prescribed. This includes taking someone else’s medication or taking pain medication to induce feelings of euphoria instead of relieving pain. The medical terms addiction, substance abuse, and substance dependence have been replaced in recent years with the term SUD. This may refer to an addiction to nicotine, alcohol, prescription medications, or illicit drugs. Separate from these, there also exists another phenomenon called pseudoaddiction, in which the patient becomes intensely fearful of being in pain. This is common in postoperative patients and usually manifests as clock-watching, asking to be awoken to receive pain medication, and hypervigilance with documenting and monitoring pain medications. Pseudoaddiction usually resolves with effective pain management treatments and the resolution of painful stimuli (in the postoperative patient, this is the healing of the surgical site). Psychological dependence occurs when medication ingestion becomes associated with alleviating discomfort, such as pain, anxiety, depression, etc. The presence of that drug then becomes a calming and reassuring presence in the patient’s life, similar to a comfort or security object (CDC, 2024a; Horn et al., 2026).

Evidence-Based Practice Alternatives to Opioids

Although APRNs have been professionally prepared to effectively and safely prescribe medications to treat and manage medical conditions as a vital component of the overall treatment plan, evidence suggests that most graduate nursing programs have limited formal education in pain management and controlled substance pharmacology. Given the unique risks associated with controlled substances, their use, misuse, and potential drug interactions, consistent and diligent review of best practices and the most recent evidence in the field of pharmacology are necessary components of a safe and effective prescribing practice (Dowell et al., 2022; Phoenix et al., 2023).

Before Prescribing

As with most medical conditions, treatment should begin with a comprehensive history and physical, including information and assessment specific to pain. It should include a full list of current and past medical conditions and a review of all medications currently being prescribed or taken (including over-the-counter [OTC]) and how they are being taken. If possible, a copy of the patient’s records from previous providers can be used to corroborate the patient’s history. Additional history components should include family history, social history, substance use history, and depression screening (i.e., the Patient Health Questionnaire-2 or -9) when clinically appropriate and using trauma-informed care principles. Family history should include substance use/misuse or mental health conditions specifically. The review of systems should consist of questions related to controlled substances and their use, such as nausea, constipation, cognitive changes/impairment, and a full pain assessment, including pain severity rating, location, quality, duration, treatment history, and aggravating/alleviating factors. The APRN should become familiar with and use the acronym of their choice for a full and consistent pain assessment every time (OLDCART, COLDERAS, SOCRATES, OPQRST, etc.). Pain severity should be self-reported consistently at each visit to allow for trend identification. Commonly used tools for pain severity assessment include the verbal rating scale (patients choose from three to six adjectives to describe their pain ranging from no pain to severe pain), a numerical rating scale (patients choose a number between 0 and 10), a Faces pain scale (uses multiple facial expressions indicating increasing levels of discomfort), and a visual analog scale (requests that the patient indicates their current level of pain with a handwritten mark on a line representing a continuum of no pain to the worst pain). The tool chosen for each patient should be based on individual circumstances. For example, children and those with language barriers or developmental delays may be best suited for the Faces pain scale, while a numerical rating may suffice in an emergent or urgent care setting where time and efficiency are a concern. Additional options include the Pediatric Pain Questionnaire, the Adolescent and Pediatric Pain Tool, the revised Face, Legs, Activity, Cry, Consolability (r-FLACC) tool, and the individualized numeric rating scale (INRS). The provider should also assess the impact of the pain on the patient’s quality of life (QOL) and daily function, as well as the effectiveness of any current or prior pain management interventions. The Pain, Enjoyment, General Activity (PEG) tool and/or the Brief Pain Inventory (BPI) may standardize this portion of the assessment (Friedrichsdorf, 2026; Horn et al., 2026; Tauben & Stacey, 2026).

Social history should include socioeconomic status, employment status, housing situation, family support, and leisure activities. Substance use history should include questions detailing past or present use of tobacco, alcohol, illicit drugs, and the misuse of any OTC or prescription medications in the past, including details such as timing, duration, their drug of choice, treatment obtained, pending legal decisions, etc. (Horn et al., 2026; Tauben & Stacey, 2026). SAMHSA (2024a) estimates that about 40% of adolescents with an SUD also had a major depressive episode in the last year, and 33% of adults with an SUD had a mental illness. Mental illness in this context includes depression, anxiety, ADHD, and various other psychiatric disorders. They found that opioid misuse is more common among those adults with a serious mental illness, compared to those with any mental illness or no mental illness (SAMHSA, 2025a). In addition, patients with chronic pain have a higher rate of depression than the general public, making their pain management more challenging for the APRN if left untreated. The Beck Depression Inventory (BDI) and the 9-Item Patient Health Questionnaire Depression Module (PHQ-9) are effective in screening for depression, while the General Anxiety Disorder-7 (GAD7) can be used if anxiety is suspected. The World Health Organization (Five) Well-Being Index (WHO-5) is a five-item tool assessing feelings of calmness, happiness, peacefulness, energy, and interest in life over the last 30 days (Tauben & Stacey, 2026; Williams & Nieuwsma, 2025). The US Preventive Services Task Force (USPSTF) also recommends depression screening for all adults with a brief tool such as the PHQ, the Center for Epidemiologic Studies Depression Scale (CES-D), the Geriatric Depression Scale (GDS) in older adults, and the Edinburgh Postnatal Depression Scale (EPDS) in individuals who are pregnant or postpartum (USPSTF, 2023).

Anxiety/Insomnia Treatment

Sleep hygiene should be reviewed with all patients describing insomnia symptoms to attempt nonpharmacological correction of poor sleep habits. Cognitive behavioral therapy (CBT) is an effective therapy for chronic insomnia. BZDs are not considered first-line treatment for insomnia. To offer similar but safer alternatives to BZDs, the pharmacology industry developed benzodiazepine receptor agonist (BZRA) sleep medications, including zolpidem (Ambien), eszopiclone (Lunesta), and zaleplon (Sonata). They act on the same GABA type A receptors in the brain as traditional BZDs, but with a different chemical structure, thought to result in fewer side effects and less risk of dependence. These medications remain classified as schedule IV, generally considered to have a lower risk than BZDs, but still have a meaningful misuse and dependence risk. They commonly cause drowsiness, headaches, dizziness, and parasomnias. Rare but serious effects include complex sleep behaviors (e.g., sleepwalking), abnormal thoughts or behaviors, amnesia, and anxiety. Safer pharmacologic options should be considered for insomnia before BZDs. Dual orexin receptor antagonists (DORAs), such as lemborexant (Dayvigo), suvorexant (Belsomra), and daridorexant (Quviviq), are categorized as schedule IV by the US Food and Drug Administration (FDA), and target wake-promoting pathways with a favorable safety profile. Ramelteon (Rozerem) is a synthetic melatonin receptor agonist that binds to MT1 and MT2 receptors, helping to induce sleep without any misuse or addiction potential. Doxepin (Silenor) is a tricyclic antidepressant, with a primary action of histamine H1 blockade at low doses, approved to treat sleep maintenance insomnia. Melatonin is an OTC option that may help regulate sleep–wake timing rather than reliably induce sleep. These options are safer than BZDs (Neubauer, 2026).

CBT is considered a first-line treatment for anxiety disorders, either alone or in combination with pharmacotherapy, depending on symptom severity and patient preference. There are also medications available to treat anxiety that are associated with less risk for misuse and dependence. First-line pharmacotherapy for GAD includes selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). When first-line pharmacotherapy is ineffective or not well tolerated, alternative or adjunctive treatments may be considered. In individuals with a history of SUD, noncontrolled agents such as hydroxyzine (Vistaril), a sedating first-generation antihistamine, may be used for short-term symptom relief. BZDs may be considered for short-term relief of severe anxiety in individuals without a history of SUD, with careful attention to dosing and duration due to the risk of tolerance and dependence. The lowest effective dose should be used, and medications should be tapered gradually when discontinued. In patients who do not respond to initial therapy with two trials of an SSRI or SNRI, alternative treatments include buspirone (Buspar), gabapentin (Neurontin), and pregabalin (Lyrica). These agents should be used cautiously, as pregabalin (Lyrica) carries a higher risk of dependence and misuse than gabapentin (Neurontin; Stein & Craske, 2026).

ADHD Treatment

While stimulants are the preferred pharmacological treatment for ADHD, nonstimulants are recommended for patients with a history of SUD. Nonstimulants are effective in reducing ADHD symptoms, though they generally have a slower onset and smaller effect size than stimulants. Nonstimulants can help improve focus and attention and decrease impulsivity. Atomoxetine (Strattera) is the recommended first-line treatment for ADHD in adults with a history of SUD. It is not a controlled substance and is determined to have low misuse potential. Atomoxetine (Strattera) has a slower onset, with full therapeutic effects often occurring over 6–8 weeks. An acceptable alternative to atomoxetine (Strattera) is viloxazine (Qelbree), a nonstimulant norepinephrine reuptake inhibitor (Brent et al., 2026).

Acute Pain Management

To alleviate pain and suffering has been one of the basic tenets of medical care since its inception. Pain can be broken down into two basic categories: acute (occurring for less than 3 months) and chronic (longer than 3 months). Their care differs greatly. Acute pain is often self-limiting, and if nonpharmacological treatments can be used effectively, they are recommended over medications. Safer alternatives should always be explored/attempted before initiating a controlled substance if those alternatives exist. Nonpharmacological therapy should be optimized first. Nonpharmacological treatments such as heat, ice, elevation, rest, massage, acupuncture/pressure, or spinal manipulation have low- to moderate-quality evidence but generally low risk. Heat therapy is effective for acute and subacute low back pain, and massage may be beneficial as adjunctive therapy for postoperative pain. Episodic migraine may respond in selected patients to remote electrical neuromodulation (Dowell et al., 2022; HHS, 2019b; Mariano, 2026).

Mild to moderate non-neuropathic, noncancer pain likely does not warrant an opioid. Nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen (Tylenol) should be trialed first if pharmacological treatment is required. Skeletal muscle relaxants, such as cyclobenzaprine (Flexeril), may be considered for select conditions like acute low back pain; however, agents such as carisoprodol (Soma) are generally discouraged due to increased risk of misuse and dependence. Skeletal muscle relaxants used to treat muscle spasms postoperatively may reduce pain and opioid requirements in select postoperative patients (Dowell et al., 2022; HHS, 2019b; Schwenk, 2025). Treatment recommendations for soft tissue musculoskeletal injuries include relative rest, ice, compression, acetaminophen (Tylenol), and NSAIDs. Tylenol with codeine (Tylenol #3) has not been shown to be superior to NSAIDs for the treatment of soft tissue musculoskeletal injuries, yet it carries a greater risk (Dönmez & Torgutalp, 2026). Opioids and barbiturates are not recommended for the treatment of migraines, as they have limited efficacy, no high-quality evidence to support their use, lead to an increased risk for chronic migraines and medication-overuse headaches, and have higher risks for dependence, SUD, and overdose. Treatment options to consider prior to opioids include NSAIDs, acetaminophen (Tylenol), serotonin 1b/1d agonists (triptans), antiemetics, calcitonin gene-related peptide (CGRP) antagonists, selective serotonin 1F receptor agonists, and ergotamines (Schwedt & Garza, 2026).

NSAIDs are associated with GI, renal, and cardiovascular risks, which must be considered when selecting therapy. Compared with nonselective NSAIDs, cyclooxygenase-2 (COX-2) selective inhibitors such as celecoxib (Celebrex) are associated with a lower risk of gastric ulcers, although renal risk is similar between COX-2 selective and nonselective NSAIDs. Gastroprotective strategies, including the addition of misoprostol (Cytotec) or a proton pump inhibitor (PPI), have been shown to reduce NSAID-associated upper GI complications; H2 receptor antagonists are less effective for this purpose. No NSAID is considered renally safe, and all may contribute to acute kidney injury, particularly in older adults or those with chronic kidney disease, volume depletion, or concomitant diuretic or renin–angiotensin system inhibitor use. NSAID cardiovascular risk varies by agent, with diclofenac (Cambia) and some COX-2 selective inhibitors associated with higher risk and naproxen (Naprosen) demonstrating the most favorable cardiovascular safety profile. All NSAIDs may increase blood pressure by approximately 3–5 mmHg and are associated with an increased risk of heart failure exacerbation and hospitalization (Ribeiro et al., 2022; Solomon, 2026).

Chronic Pain Management

              Chronic pain (excluding cancer patients, palliative care, and end-of-life [EOL] care) treatment, like acute pain, should always start with and include nonpharmacologic and nonopioid treatment options, as described above. Nonopioid therapies for subacute and chronic pain are preferred. Other than those listed above, nonpharmacological treatments often used successfully for chronic back or neck pain include CBT and other psychotherapies, exercise therapy (i.e., for back pain, osteoarthritis pain in the hips or knees, and fibromyalgia), yoga, and physical therapy (i.e., manual techniques for hip osteoarthritis). These treatments should be tried first or incorporated with any pharmacological treatment that is deemed appropriate. Unfortunately, these treatments often have an associated cost and may not be covered fully by traditional health insurance. An effective strategy to decrease medical costs and drug use and improve wellness for large portions of the population would be enhanced insurance coverage and access to these treatment options (Dowell et al., 2022).

Topical NSAIDs can relieve pain due to isolated (or limited) osteoarthritis. Those with neuropathic pain may find topical capsaicin or lidocaine patches effective. Systemic NSAIDs can be added for arthritis-related chronic pain and low back pain. Additional nonopioid pharmacologic options include gabapentinoids (gabapentin [Neurontin] and pregabalin [Lyrica]), and antidepressants such as duloxetine (Cymbalta), venlafaxine (Effexor), or tricyclic antidepressants, particularly for neuropathic pain, fibromyalgia, or chronic pain accompanied by depression or anxiety. Opioids are not first-line options for subacute or chronic pain. Opioid treatment should only be added when these treatments are deemed inadequate and the potential benefits of opioids outweigh the risks. Studies indicate minimal improvement in pain or function when opioids were used to manage chronic pain at short-term follow-up versus placebo and no improvement in pain or function versus nonopioid treatment (Dowell et al., 2022; Tauben & Stacey, 2025).

Systemic corticosteroids are not recommended for the management of chronic noncancer pain due to limited longer term benefit and substantial adverse effects, especially in patients with diabetes. In contrast, intraarticular glucocorticoid injections may provide short-term pain relief and improved joint function, which can improve participation in physical therapy or exercise. Similarly, epidural steroid injections may relieve lumbar radicular pain, although benefits may be short-term (Dowell et al., 2022; HHS, 2019b).

              In New York State, APRNs, physician assistants (PAs), physicians, and certain other licensed practitioners may certify patients for medical cannabis through the Office of Cannabis Management (OCM). Practitioners must hold a valid New York State license, maintain an active DEA registration to prescribe controlled substances, complete at least a 2-hour state-approved medical cannabis education course, and register with the state’s Medical Cannabis Data Management System before issuing certifications. New York’s medical cannabis program does not rely on a fixed list of qualifying diagnoses; rather, patients may be certified when the practitioner determines, using clinical judgment, that the patient is likely to benefit from medical cannabis. Conditions for which patients commonly seek certification include chronic pain and SUD. Once certified, patients must complete registration with New York State in order to access medical cannabis products from registered organizations. Medical cannabis may serve as part of a comprehensive pain-management strategy, including opioid-sparing approaches, although its use should be guided by clinical evidence and patient-specific factors (New York State Office of Cannabis Management, n.d.).

As of June 2025, the medical use of cannabis products is legal in 40 states as well as the District of Columbia, Guam, Puerto Rico, and the US Virgin Islands. In addition, there are eight additional US states that allow the use of “low tetrahydrocannabinol (THC), high CBD” products for medical reasons in specific situations. 24 states, three territories, and the District of Columbia have legalized or regulated recreational use of cannabis by adults without medical certification (National Conference of State Legislatures [NCSL], 2025).

Controlled Substance Prescribing

After making the critical decision to prescribe a controlled substance based on all the information gathered above, what can prescribers do to optimize safety and effectiveness? Recommendations start with an informed discussion and a patient–provider agreement (PPA). Informed discussion should occur during the initial visit before prescribing. It should include the patient’s diagnosis, the specific treatment being prescribed, risks, benefits, and desired outcomes/goals of treatment. Those goals should be collaborative. This discussion should also cover alternatives (including no treatment) with their associated risks and benefits. At a minimum, risks should include the possibility of side effects (i.e., respiratory depression, cognitive effects), SUD, overdose, development of physical or psychological dependence or tolerance, drug interactions, hyperalgesia, inadvertent ingestion by children or others, and drug misuse by the patient/household contacts/friends. The risk of neonatal opioid withdrawal syndrome (NOWS)/neonatal abstinence syndrome (NAS) if the patient becomes pregnant should also be discussed. The prescriber should review policies regarding refills and lost or stolen medications (Dowell et al., 2022; Horn et al., 2026; Rosenquist, 2026).

The PPA (also referred to as a narcotic contract, an opioid contract, or a physician treatment agreement) is a separate document signed by both the prescriber and the patient. PPAs are adjunctive tools and should not replace individualized clinical judgment or ongoing therapeutic dialogue. It should facilitate a discussion regarding expectations, adherence, and treatment goals. Although specific contracts vary, they may cover both parties’ responsibilities/expected behaviors, the goals and potential risks of controlled substance use, and the steps that may be taken if safety concerns arise. If urine drug tests (UDTs) or pill counts are to be performed periodically to assess compliance, this is typically included in the PPA, as well as how medication refills and changes should be requested and obtained by the patient and handled by the office staff and providers. PPAs may specify that the patient is expected to use a single prescriber for all of their controlled substance needs; some may simply limit the patient to one prescriber for pain medicine but allow the patient to obtain prescriptions from other providers for other controlled substances (i.e., BZDs, stimulants for ADHD). This tool should also include the provider’s responsibilities regarding treatment and follow-up care. The PPA can initiate conversations and provide valuable information (HHS, 2019b; Horn et al., 2026). Although these documents can be helpful, the CDC does not require, mandate, or explicitly recommend PPAs. Instead, the CDC emphasizes patient-centered communication, shared decision-making, and ongoing reassessment while cautioning against rigid or punitive practices (Dowell et al., 2022).

UDT can be useful for baseline and periodic testing, but it is imperfect, as false positives can occur. Ingestion of poppy seeds or rare herbal products derived from Papaveris fructus may cause positive morphine results. A negative result for a prescribed drug may indicate that the patient is not taking the drug, is not taking the correct dose, or the results are inaccurate. A positive result for an unexpected drug could mean the patient took it illicitly, it is a metabolite of a prescribed drug, or the results are inaccurate. For example, hydrocodone has been detected in patients using codeine (Tylenol #3), and hydromorphone has been seen in the results of patients using hydrocodone (Vicodin), as these drugs are metabolites. The cost of UDT should also be considered, discussed with the patient, and included in the initial treatment plan or patient–provider agreement (PPA). How the results of a UDT will be interpreted, confirmed, and used, including its effects on the continuation of treatment, should be explained to the patient before testing. Prescribers should also consider screening for pregnancy concurrently via a single urine sample/specimen in female patients. The CDC recommends considering baseline UDT and annual repeat testing (at least) for patients with chronic pain who are on opioids. The frequency can be adjusted based on risk level (every 3–12 months based on an assessed risk level of low to high; Becker & Starrels, 2026; Dowell et al., 2022; Horn et al., 2026).

The use of electronic databases to track controlled substance prescriptions (prescription drug monitoring programs [PDMPs]) has become widespread across the United States, including most states, Washington, DC, and several US territories. They aim to improve opioid prescribing, inform clinical practice, and protect at-risk patients. States arrange individual systems to track and monitor prescriptions, but the details about use, access, and which drugs are included, and the regulations and implications for prescribers vary greatly. Most states require prescribers to consult the system, and most also have a method by which users can access patients’ records in other or neighboring states (PMP Interconnect). As of the spring of 2026, all 50 states in the United States operate statewide PDMPs. Reporting frequency varies by state and is not universally real-time, and most states mandate PDMP checks for certain controlled substances (commonly opioids), with state-specific exceptions. Differences exist between the states regarding how frequently providers should monitor the system and which schedules of controlled substances are included. Also, some federal agencies now participate, including the Veterans Administration (VA) and the Indian Health Services (IHS). Evidence suggests that PDMP implementation is associated with reduced opioid prescribing, decreased use of multiple prescribers (“doctor shopping”), enhanced regulatory oversight, and improved communication between prescribers and pharmacists. The CDC recommends reviewing PDMP data prior to initiating opioid therapy and periodically during ongoing treatment, ideally at least every 3 months (CDC, 2024b; Dowell et al., 2022; D’Souza et al., 2024; Horn et al., 2026). It is important to note that reporting errors may occur, and not all medical sources may be included in the database, such as methadone dispensed from opioid treatment programs (Becker & Starrels, 2026).

Prior to initiating opioid therapy or other long-term controlled substances with misuse potential, clinicians should consider the use of an opioid use disorder (OUD) risk assessment tool, a UDT, and a review of the state’s PDMP to enhance the prescriber’s assessment of the potential future risk of misuse and guide risk–benefit decisions. Risk assessment tools have limited predictive validity and should complement, but not replace, clinical evaluation. Some options for an OUD risk assessment tool are as follows:

• Opioid Risk Tool (ORT): a five-question self-administered tool that assesses personal/family history; screens only for future risk of drug misuse and is designed for adult patients
• Screener and Opioid Assessment for Patients with Pain (SOAPP) assesses prior substance misuse, mood, stress, and other risk factors to identify the level of risk for the patient
• Diagnosis, Intractability, Risk, and Efficacy (DIRE) is a questionnaire that aims to determine suitability for long-term opioid use by predicting adherence (Becker & Starrels, 2026; Horn et al., 2026; NIDA, 2023a; Rosenquist, 2026)

This list is by no means exhaustive, and the most important part of screening for future risk is that the prescriber is familiar with the tool they are using, understands how and why it was developed, and is trained properly in its execution and interpretation. Ultimately, a patient’s risk should be considered among the other data collected to make the best decision regarding appropriate treatment. A high-risk score may indicate the need for a referral to a pain management clinic with additional experience and expertise in treating pain in more complex, higher risk patients. Risk factors for opioid misuse include younger age, a personal or family history of SUD, a comorbid psychiatric condition such as depression or anxiety, and a history of legal issues or incarceration. Differences observed by race largely reflect historical prescribing patterns and access to opioids rather than inherent biological risk. Risk factors for stimulant misuse include young adults aged 18–25 and are associated with nonmedical use patterns such as binge drinking, cannabis use, and a history of behavioral disorders; certain social environments have demonstrated higher prevalence in observational studies. Identified risk factors for CNS depressant misuse include psychiatric comorbidity, polysubstance use, alcohol misuse, and prior substance use, particularly injection drug use (Becker & Starrels, 2026; Horn et al., 2026; NIDA, 2023a).

Finally, a complete physical exam should be performed and documented appropriately before any prescriptions are granted and periodically throughout the treatment course (Dowell et al., 2022). In New York State, controlled-substance prescribing requirements are governed by Title 10 NYCRR § 80.63. As a general rule, an in-person medical evaluation is required prior to issuing a prescription for a controlled substance. However, in limited emergency circumstances, a practitioner may prescribe a controlled substance for a new medical condition without first performing an in-person medical evaluation if there is an existing practitioner–patient relationship, the immediate administration of the medication is necessary, no alternative treatment is available, and the prescription does not exceed a 5-day supply (New York State Department of Health [NYSDOH], 2026).

Acute Pain

As with any new prescription medication, all current medications should be reviewed for potential interactions, and any medication allergies/sensitivities should be confirmed. Due to the substantially increased risk of overdose, respiratory depression, and death, opioids should generally not be combined with BZDs except in rare circumstances where the benefits clearly outweigh the risks and close monitoring is possible. Moderate pain can often be managed with lower-potency, IR opioids such as codeine (Tylenol #3) or tramadol (Ultram) in carefully selected patients; however, these agents are not inherently safer than other short-acting opioids and have unique risks related to variable metabolism and adverse effects. Treatment for acute severe pain (e.g., burns, crush injuries, postoperative invasive surgery) in a patient who can swallow may be initiated using a short-acting oral opioid such as hydrocodone (Vicodin), oxycodone (Percocet), or morphine sulfate (MSIR). Hydromorphone (Dilaudid) should be used with caution in opioid-naïve patients due to its higher potency. Fentanyl (Duragesic) and methadone (Methadose) should not be used as initial options due to their dosing challenges, complex pharmacokinetics, and elevated overdose risk. These should only be prescribed by providers very familiar and comfortable with these products. IR medications should be started initially with opioid-naive patients until the dose is established and stable. The initial opioid prescription should be considered a trial, with a follow-up appointment scheduled at a predetermined time to evaluate analgesic effectiveness, functional improvement, adverse effects, and progress toward established treatment goals. Dose adjustments may need to be made as early as every 2–3 days, but patients who are being seen outpatient for short-term acute pain that are opioid-naïve will likely not require a dosage adjustment. If the dose increases, the patient should be monitored closely for sedation and respiratory depression. Controlled substances should be given at the lowest effective dose possible and for the minimum duration required. If opioids are to be used for acute pain, all prescription quantities should be individualized to the clinical scenario, but the prescription should be limited to the expected duration. For most acute, nontraumatic/nonsurgical pain, a quantity to last a few days or less is typically adequate. ER or long-acting (LA) formulas in the same family with a half-life of 8–12 hours should be avoided initially, but may be considered if long-term therapy is clearly indicated and the patient demonstrates stability. Prescribers should become familiar with certain medications they prefer and commonly prescribe to familiarize themselves with the details of those particular drugs extensively and avoid prescribing different or unfamiliar medications when possible (Dowell et al., 2022; Horn et al., 2026; Rosenquist, 2026)

Documentation is key when prescribing controlled substances for safety and legal reasons. Patients’ visit notes should be clear and concise and include all details of dose adjustments or medication changes with associated justifications and equivalency calculations. Notes should also include the effectiveness of treatments based on consistent pain assessments repeated at each visit, and any adverse effects and associated treatments required. Documentation should also specify if the patient is adhering to treatment plans as outlined in the PPA and include the results of any UDTs or pill counts. Any concerning or aberrant behavior should be carefully documented with as much detail as possible, with a clear plan for resolution and/or future monitoring. The Pain Assessment and Documentation Tool (PADT) is a documentation tool to consider. This two-sided chart progress note provides the framework for a follow-up visit to reassess pain control and the current pain management regimen. Interviews with family members and caregivers, when appropriate and with patient consent, can also be included in documentation records for these same reasons. Any letters sent to patients should be included in the patient’s electronic medical record (EMR), and office staff should carefully document any phone calls made or received. Every time PDMP reports are reviewed, this should be documented along with any concerning findings. A decision to terminate care needs to be documented thoroughly (Dowell et al., 2022; Horn et al., 2026; Rosenquist, 2026).

Chronic Pain

              Opioids are not first-line options for acute, subacute, and chronic pain. Opioid treatment should only be added when these treatments are deemed inadequate and the potential benefits of opioids outweigh the risks. Studies indicate minimal improvement in pain and no consistent improvement in function when opioids were used to manage chronic pain at short-term follow-up versus placebo and no improvement in pain or function versus nonopioid treatment. Functional, concrete, and measurable goals should be agreed upon before treatment initiation (refer to the PPA section above for further details on this), as well as a plan for discontinuation of treatment if benefits do not outweigh risks and there is no clinically meaningful improvement in pain and function. Risks, benefits, and responsibilities of both patient and provider should be communicated (and included in the informed discussion and PPA paperwork, if applicable) so that they can be reviewed periodically whenever necessary (Dowell et al., 2022).

As mentioned above, the lowest effective dose of IR opioids should be used initially, avoiding ER or LA options until a stable dose has been established. The HHS (2019b) suggests the acronym as low as reasonably achievable (ALARA). The CDC (Dowell et al., 2022) no longer recommends that primary care providers reassess the risks and benefits of treatment when prescribing more than a certain amount of morphine milligram equivalents (MME) daily. Instead, the guidelines suggest simply prescribing the lowest effective dose of opioids and carefully considering the potential risks and benefits before any dosage adjustments (up or down). The CDC recommends using FDA product labeling as a reference and adjusting based on patient-specific factors such as pain severity and known hepatic or renal insufficiency. The CDC notes that labeling-consistent starting doses for opioid-naïve patients often fall in the range of approximately 5–10 MME per dose or 20–30 MME/day, depending on the formulation and clinical context (refer to Table 2). They also remind prescribers that most patients do not report an improvement in pain or function when given 50 MME/day or more of any opioid despite an increase in known risk (Dowell et al., 2022).

Table 2

Recommended Starting Doses for Commonly Prescribed Opioids

(UpToDate Lexidrug, n.d.-a; Rosenquist, 2026)

The CDC provides MME conversion tables to assist clinicians in estimating opioid dosage and cumulative exposure when making dosage changes or transitioning between opioids (refer to Table 3; Dowell et al., 2022). These estimates are approximate and should be used cautiously, particularly when rotating opioids, due to incomplete cross-tolerance and interindividual variability. Certain opioids, such as methadone (Methadose) and tapentadol (Nucynta), require special consideration, as standard MME conversions are unreliable. When initiating or increasing the dose of opioids for subacute or chronic pain, follow-up within 1–4 weeks is recommended to assess for benefits and any harms; once stable, follow-up at least every 3 months is suggested (Dowell et al., 2022).

Table 3

Morphine Milligram Equivalent (MME) Conversion Factors for Commonly Prescribed Opioids per the CDC

(Dowell et al., 2022)

Opioids commonly cause significant side effects, which should be explained and discussed with the patient before prescribing. The most common are constipation, dry mouth, nausea, vomiting, confusion, and drowsiness. Constipation can be prevented with a bowel regimen that includes increased fluid intake, oral fiber intake, and physical activity. A stimulant laxative (e.g., sennosides [Senokot]) may be given prophylactically with a stool softener. Over time, patients taking opioids are at risk of developing tolerance and physical dependence. If stopped abruptly, patients are at risk of withdrawal (Dowell et al., 2022; Portenoy et al., 2024).

Extreme caution should be used when prescribing methadone (Dolophine, Methadose), which is challenging to dose and carries drug interaction concerns related to its complex CYP450 metabolism. Its MME conversion is dose-dependent. Methadone (Methadose) also acts as an N-methyl-d-aspartate (NMDA) receptor antagonist, contributing to analgesia through NMDA receptor antagonism and inhibition of norepinephrine and serotonin reuptake, thereby enhancing descending inhibitory pathways. The half-life of methadone (Methadose) is significantly longer than that of morphine (8–60 hours, average 24 hours), with lipophilic storage, so great care should be taken with this drug to treat pain safely. However, the low cost and ease of availability often make methadone (Methadose) an attractive option if used carefully by a skilled and experienced prescriber, especially when managing cancer and EOL pain. It should not be the first choice for an LA/ER opioid due to its non-linear pharmacokinetics, accumulation risk, and cardiac safety concerns. It can prolong QTc, so cardiovascular monitoring is warranted. Follow-up visits to assess patients after starting or with dose increases of methadone (Methadose) may need to be as frequent as every 2–3 days initially (HHS, 2019b). Similarly, tapentadol (Nucynta) is a centrally acting analgesic (synthetic opioid agonist) with an added mechanism of norepinephrine reuptake inhibition in addition to its mu-receptor agonism that lacks a standard MME conversion factor (Dowell et al., 2022; Rosenquist, 2026).

Stimulants

Stimulant medications used to treat ADHD contain different types of methylphenidate and amphetamines and produce a paradoxical calming effect on hyperactivity and impulsivity by increasing CNS dopamine and norepinephrine availability, thereby improving attention and executive functioning. The most common stimulants used for ADHD are methylphenidate formulations (Ritalin, Concerta, Aptensio, Jornay PM), dextroamphetamine (Dexedrine), and mixed amphetamine salts (dextroamphetamine/amphetamine [Adderall]). They are available as IR formulas lasting about 4 hours, LA formulas lasting about 6–12 hours, and ER formulas that may last up to 24 hours. Many patients and caregivers prefer LA or ER formulations because they reduce symptom rebound and variability throughout the day and eliminate the need for medication administration during school or work hours. Comorbid conditions and other medications must be considered when prescribing stimulants. PPIs, such as omeprazole (Prilosec) and esomeprazole (Nexium), can interfere with the absorption of specific pH-dependent ER methylphenidate formulations, though this effect is formulation-specific and not universal. Stimulants are also associated with a rare risk of serious cardiovascular events, primarily in patients with underlying structural heart disease or significant arrhythmias; therefore, a thorough cardiac and family history is essential prior to initiation. Dextroamphetamine/amphetamine (Adderall) can be administered with or without food but should be taken in the morning to avoid insomnia. Patients taking the ER formulation should swallow capsules whole, or the contents can be sprinkled on a bite of food that does not require chewing (e.g., applesauce or pudding; Wolraich et al., 2019; Wolters Kluwer, 2025). Dextroamphetamine (Dexedrine) should not be administered in the late evening due to the risk of insomnia. This medication interacts with antihypertensives (diminishes effects), monoamine oxidase inhibitors (MAOIs; may cause severe hypertension), and acidic foods or fruit juices, resulting in delayed absorption and decreased effectiveness. It should be used cautiously in patients experiencing agitation, motor or phonic tics, or Tourette syndrome (Wolters Kluwer, 2025).

Lisdexamfetamine (Vyvanse) is an LA preparation and differs from other medications in this class due to its pharmacokinetics. It is considered a prodrug, which means it must undergo chemical conversion by metabolic processes before becoming an active agent. After GI absorption, lisdexamfetamine (Vyvanse) is converted to dextroamphetamine primarily within red blood cells, rather than in the GI tract or liver. As a result, the onset of therapeutic effects is delayed, typically occurring within 60–90 minutes. The drug has lower misuse potential than dextroamphetamine/amphetamine (Adderall), as it cannot be absorbed intravenously or transmucosally. Dosing must be adjusted for patients with severe renal impairment. For patients with a glomerular filtration rate (GFR) of 15–30 mL/min/m², the maximum dose is 50 mg/day. For those with end-stage renal disease (ESRD) or a GFR below 15 mL/min/m², the maximum dose is 30 mg/day. Lisdexamfetamine (Vyvanse) should be taken once daily in the morning with or without food to prevent insomnia (Wolraich et al., 2019; Wolters Kluwer, 2025). Amphetamine-based stimulants, including lisdexamfetamine (Vyvanse), may have altered absorption when taken with acidifying or alkalinizing agents, such as antacids or acid-reducing medications. MAOIs are contraindicated with both amphetamine- and methylphenidate-based stimulants due to the risk of hypertensive crisis. Because methylphenidate (Concerta) does not dissolve after ingestion, it is contraindicated in patients with known GI narrowing or obstruction (e.g., strictures, achalasia, severe inflammatory bowel disease, obstructing tumors). All stimulants should be used cautiously in patients with a history of bipolar disorder, seizure disorders, psychosis, and severe anxiety or agitation (Wolters Kluwer, 2025).

The side effects of stimulants include hypertension, tachycardia, anxiety, decreased appetite, sleep problems, mood or behavioral changes (e.g., irritability, emotional blunting), tics, stomach pain, and headaches. Less commonly reported side effects include allergic reactions, fever, arthralgia, psychosis, and depression. Sudden death is a rare adverse effect in patients with preexisting cardiac conditions. These drugs should be used cautiously in patients with hypertension, seizures, a history of myocardial infarction, stroke, renal or hepatic disease (depending on the specific agent), or anxiety disorders. Stimulants are contraindicated for patients with advanced arteriosclerosis, hyperthyroidism, symptomatic cardiovascular disease, structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, or glaucoma. APRNs should counsel patients on strategies to manage insomnia, including taking the medication before noon, limiting or avoiding caffeine, and maintaining healthy sleep hygiene. When insomnia requires pharmacological management, melatonin is encouraged as the initial intervention, as it naturally occurs in the body and is nonaddicting. Some patients may benefit from adjunctive prescription agents such as clonidine (Catapres) or trazodone (Desyrel), which may be used in both children and adults when clinically indicated. Medications such as eszopiclone (Lunesta) and zolpidem (Ambien) are generally reserved for adults and should be taken 30–60 minutes before bedtime (National Institute of Mental Health, 2023; Tusaie & Fitzpatrick, 2026; Wolters Kluwer, 2025).

Stimulants carry a risk for diversion, defined as the use of prescribed ADHD medications for purposes other than their intended medical indication. When taken at doses and via routes other than those prescribed, stimulants can increase dopamine levels in the brain in a rapid and highly amplified manner (similar to other substances of misuse that activate central dopamine reward pathways, though via different mechanisms), thereby disrupting communication between brain cells and producing euphoria. As a result, these biochemical processes and subsequent euphoric effects increase the risk of addiction. Therefore, before prescribing these medications, providers must assess each patient's risk for diversion and continue to reassess at each follow-up visit while continuing treatment. Following drug selection, providers are advised to “start low and go slow” when prescribing these agents, initially prescribing the lowest dose possible and gradually titrating the dose upward to minimize side effects. Most side effects can be minimized or significantly reduced with this medication initiation plan. Some people describe a stimulant rebound during the period between dosing, as the medication is wearing off, in which they can experience a negative mood, fatigue, or hyperactivity. These symptoms can be managed by changing the dose or schedule of IR formulas or switching to an LA formula if possible (Brent et al., 2026; Children and Adults with Attention-deficit/Hyperactivity Disorder [CHADD], n.d.; Wolraich et al., 2019).

CNS Depressants

BZDs are effective at improving anxiety and insomnia symptoms but are no longer recommended as first-line therapy due to their side effect profile and the risk of tolerance, dependence, or misuse. For patients with severe anxiety without a history of substance use, a BZD may be initiated to manage symptoms until the first-line treatment, such as SSRIs or SNRIs, reaches therapeutic effect. They are also commonly used for brief procedural anxiety, such as during dental or minor medical procedures, and for presedation. BZDs enhance the effects of GABA in the brain, resulting in anxiolytic, sedative, muscle-relaxant, and anticonvulsant effects. Commonly prescribed BZDs include clonazepam (Klonopin), alprazolam (Xanax), diazepam (Valium), and lorazepam (Ativan). Of these, diazepam (Valium) and clonazepam (Klonopin) have longer half-lives, which may reduce the severity of withdrawal symptoms when discontinued but also increase the risk of accumulation and sedation. Alprazolam (Xanax) and lorazepam (Ativan) have a more rapid onset of action. Adverse effects of BZDs include drowsiness, dizziness, nausea, blurred vision, headache, confusion, and nightmares. Serious risks include cognitive impairment, falls, motor vehicle accidents, and respiratory depression when combined with other CNS depressants (Stein & Craske, 2026). Before prescribing a BZD, patients should be screened for risk factors of BZD use disorder, including a history of SUD, older age, prolonged duration of use, higher prescribed doses, psychiatric comorbidities, and concurrent use of opioids or alcohol. Longer treatment duration and dose escalation are strongly correlated with increased risk of dependence and misuse (Park, 2026).

Special Populations: Older Adults or Pregnant Patients

Special consideration should be taken when prescribing for adults over age 65 or individuals who are pregnant. Pain is more common in older adults, and aging causes physiological changes that affect medication absorption, metabolism, and excretion. For these reasons, medications should be started at the lowest possible dose and gradually increased only as needed (start low and go slow). When prescribing opioids, a bowel program to prevent constipation may be advised, as described above. The American Geriatric Society Beers Criteria (BC, 2023) of potentially inappropriate medication use in older adults outlines medications that should be avoided. Included in the most recent version are the following recommendations (The American Geriatrics Society Beers Criteria Update Expert Panel, 2023):

• Barbiturates (e.g., butalbital, phenobarbital) should be avoided due to the high rate of physical dependence, tolerance, and overdose.
• BZDs should be avoided for insomnia, agitation, or delirium due to fall risk, delirium, fractures, and motor vehicle crashes, especially longer acting versions. There is a risk of misuse and addiction. Especially when combined with opioids, they can lead to respiratory depression, sedation, coma, and death.
• Non-BZD, BZD receptor agonist hypnotics (eszopiclone [Lunesta], zaleplon [Sonata], zolpidem [Ambien]) should be avoided due to the risk of falls, delirium, fractures, and motor vehicle crashes.
• Avoid meperidine (Demerol) as it is ineffective and carries an increased risk of neurotoxicity compared to other opioids.
• Opioids should be avoided when possible in those with a history of falls or fractures; they also increase delirium risk.
• Combining BZDs and opioids increases the risk of overdose and adverse events.
• Combining opioids and AEDs such as pregabalin (Lyrica) and gabapentin (Neurontin) increases the risk of sedation, respiratory depression, and death.
• Combining three or more CNS depressants increases the risk of falls and fractures.
• Antipsychotic drugs should be avoided as a first-line treatment for delirium unless the patient is a threat to self or others due to the increased risk of stroke, cognitive decline, mortality, and orthostatic syncope (e.g., with olanzapine [Zyprexa]).
• Tricyclic antidepressants should be avoided/used with caution secondary to anticholinergic effects.
• Avoid using indomethacin [Indocin] and ketorolac [Toradol] due to the increased risk of GI bleeding, peptic ulcer disease, and acute kidney injury.
• Avoid scheduled or chronic use of the other non-selective NSAIDs (i.e., aspirin [ASA], diclofenac [Voltaren], diflunisal [Dolobid], etodolac [Lodine], flurbiprofen [Ansaid], ibuprofen [Motrin, Advil], meloxicam [Mobic], nabumetone [Relafen], naproxen [Naprosyn], oxaprozin [Daypro], piroxicam [Feldene], and sulindac [Clinoril]) due to the risk of GI bleeding and peptic ulcer disease in those at increased risk (over 75, on corticosteroids, anticoagulants, or antiplatelet agents) as well as increased BP and kidney injury; this risk may be reduced (not eliminated) with a PPI or misoprostol.
• Skeletal muscle relaxants (i.e., carisoprodol [Soma], chlorzoxazone [Lorzone], cyclobenzaprine [Flexeril], methocarbamol [Robaxin]) commonly used for musculoskeletal symptoms are poorly tolerated due to anticholinergic effects, sedation, and fracture risk and should be avoided in older adults.
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In 2014, the FDA removed the older system of ranking medications for pregnant patients (Category A, B, C, D, and X) and implemented the Pregnancy and Lactation Labeling Rule (PLLR), which requires detailed narrative information regarding medication safety during pregnancy, labor and delivery, breastfeeding, and for females and males of reproductive potential (FDA, 2025). Opioid use during pregnancy has not been consistently associated with an increased risk of major congenital malformations when used therapeutically. The most significant risks include NOWS, low birth weight, and preterm birth. NOWS is typically manageable with appropriate neonatal care and is rarely fatal. Opioids are excreted into breast milk to varying degrees; while some agents are contraindicated, others may be used cautiously at the lowest effective dose with infant monitoring. Codeine (Tylenol #3), tramadol (Ultram), and mepiridine (Demerol) should be avoided if possible. Patients should be thoroughly counseled regarding maternal and neonatal risks prior to prescribing opioids during pregnancy or lactation. Acetaminophen (Tylenol) remains the preferred analgesic throughout pregnancy and is considered compatible with breastfeeding. NSAIDs should be avoided after 30 weeks of gestation due to the risk of premature closure of the ductus arteriosus and oligohydramnios; cautious use earlier in pregnancy may be considered when clinically indicated. Many NSAIDs are considered compatible with breastfeeding (Berens, 2026; CDC, 2025a; Rasmussen & Jelin, 2025). BZDs cross the placenta and may be associated with neonatal adaptation syndrome, including hypotonia, respiratory depression, and withdrawal symptoms when used near delivery. Current evidence does not demonstrate a consistent increase in major congenital malformations. Many BZDs are excreted into breast milk in low concentrations and may be used cautiously during lactation with infant monitoring, rather than being universally avoided (Hendrick, 2026; Kimmel, 2026). Zolpidem (Ambien), previously categorized as pregnancy category C, has not demonstrated teratogenic effects in human studies. Rare cases of neonatal respiratory depression or withdrawal have been reported with late-pregnancy exposure. Zolpidem is excreted into breast milk in low amounts; breastfeeding caution is advised (Hendrick, 2026; LactMed, 2025a). Stimulant medications, including methylphenidate (Ritalin, Concerta) and amphetamines(Ritalin, Concerta), were categorized as pregnancy category C and are not associated with a clear increase in major congenital malformations. Both methylphenidate (Ritalin, Concerta) and amphetamines (Dexedrine, Adderall) are excreted into breast milk; methylphenidate (Ritalin, Concerta) appears in very small amounts and is generally considered compatible with breastfeeding, whereas amphetamine (Dexedrine, Adderall) use may require closer monitoring of the infant (Brent et al., 2026; LactMed, 2025b).

Buprenorphine (Sublocade) and methadone (Methadose) appear safe and effective for treating OUD in individuals who are pregnant. Methadone (Methadose) or buprenorphine (Sublocade) is strongly preferred over continued illicit opioid use because these medications provide known dosing, stable access, and significantly improve maternal, fetal, and neonatal outcomes. Both medications are effective, but buprenorphine (Sublocade) is generally preferred in pregnancy due to associations with higher birth weights, less severe neonatal opioid withdrawal syndrome, and lower risk of preterm birth. Buprenorphine (Sublocade) monotherapy was historically favored, though recent data indicate the buprenorphine/naloxone combination (Suboxone) is also safe during pregnancy; LA injectable formulations lack sufficient evidence. Methadone (Methadose) has the longest history of use in pregnancy, but often requires dose adjustments as pregnancy progresses due to increased metabolism. Naltrexone (Vivitrol) may be continued in select patients already stable on therapy, but it is not recommended to initiate during pregnancy (Chang & Welsh, 2026; Seligman et al., 2026).

Cancer, Palliative, and End-of-Life Care

The treatment of cancer pain is extremely complex and is usually best managed by oncologists and palliative care specialists. The patient’s disease prognosis, concurrent medications, and individual goals of care should be considered. Pain management in patients who are terminally ill does not typically conform to the aforementioned standard regulations. There is less concern for misuse or addiction and more focus on effective pain relief when caring for these patients. Concerns within these populations continue to be overdose, respiratory depression, and potential loss of consciousness or hastening of EOL. Medications should be increased gradually and only as tolerated, with the full consent of the patient or their proxy medical decision-maker/guardian or via an intact living will or advance directive. The patient and/or caregivers should be fully informed of the potential risks of increased opioid doses. Still, if the patient and family prioritize pain relief over the length of life, the care team should accept and respect that decision. It is generally accepted that clinicians should never withhold needed pain medication from patients who are terminally ill for fear of hastening death if they have received informed consent from the patient. Loss of consciousness may not be directly caused by high doses of opioids in patients who are dying if those doses have been stable or slowly increasing over time, especially in chronic cancer pain. Loss of consciousness in this population is more commonly related to metabolic encephalopathy, infection, or brain metastases (Berger & O’Neill, 2021).

Medical aid in dying (or death with dignity) laws are currently in effect in 13 states and the District of Columbia. Similar laws are being considered in as many as 16 additional states this year (DeathwithDignity.org, n.d.). New York State now provides legal protection for medical aid in dying under the Medical Aid in Dying Act, signed into law in February 2026. This statute permits eligible, mentally capable adults with a terminal illness and a prognostic life expectancy of 6 months or less to obtain a prescription for self-administered medication to hasten death, subject to strict procedural safeguards. Outside the parameters of this law, assisted suicide and euthanasia remain prohibited. Prior to the enactment of the Medical Aid in Dying Act, the New York State Task Force on Life and the Law articulated foundational legal and ethical protections for the treatment of pain and EOL care. The Task Force emphasized that clinicians have a duty to provide effective pain relief and palliative care, to involve patients in decisions regarding withdrawal or withholding of life-sustaining treatment, and to utilize appropriate analgesic therapy, even when such treatment may foreseeably hasten death, provided the intent is symptom relief rather than death itself. These principles remain operative under current law and continue to guide ethical clinical practice alongside the newer statutory protections for medical aid in dying (New York State Governor Kathy Hochul, 2026).

Prevention, Screening, and Signs/Symptoms of SUD

The prevention of misuse of controlled substance medications should start with the provider; specifically, experts recommend formal continuing education regarding indications, risks, and benefits of these medications and safe prescribing practices to guide medical decision-making with the best evidence possible to limit risk to patients and society. An honest dialogue with the patient regarding risks, benefits, treatment goals, treatment alternatives, and expectations of both parties before prescribing can help prevent misuse of potentially dangerous medications. This includes using the aforementioned informed discussion and PPAs, with updates and changes as treatment is adjusted over time. A good professional relationship with the network of local pharmacists who are familiar with the local prescribers can also be helpful in monitoring for altered, falsified, or otherwise suspicious-looking prescriptions (Becker & Starrels, 2026; Dowell et al., 2022; Horn et al., 2026; NIDA, 2023b).

For patients, misuse can best be prevented by taking only their medications exactly as prescribed, discussing any changes with the prescriber before adjusting the strength or dosing frequency, and safely storing medications to avoid intentional or accidental use by anyone other than the patient for whom they were prescribed. The FDA recommends disposing of any expired or unnecessary medications at a registered drug take-back event, permanent collection site, or by mail-back program whenever possible. If take-back options are not readily available, most medications may be disposed of in the household trash after being mixed with an undesirable substance (i.e., dirt, used coffee grounds, cat litter), sealed in a plastic bag or container, and discarded; all personal information should be removed from empty medication containers before disposal (Becker & Starrels, 2026; Dowell et al., 2022; Horn et al., 2026; NIDA, 2023b). A small number of high-risk medications, including fentanyl (Duragesic) patches, methadone (Methadose), and buprenorphine (Suboxone), and other drugs included on the FDA “Flush List,” may be flushed down the toilet if no take-back option is available, as these medications pose a significant risk of fatal harm from accidental exposure or misuse (FDA, 2024).

Medication manufacturers are studying and trialing various methods to make medications less vulnerable to misuse, called abuse-deterrent formulations (ADF). These formulations incorporate physical or chemical barriers to prevent dissolving, grinding, or crushing agonist/antagonist combinations or aversive substances added that are released if the product is manipulated or taken in a way other than directed; and LA delivery systems, such as injectable or implantable formulations, which release medication slowly over time and reduce opportunities for diversion. New molecular entities/prodrugs render a drug inactive unless it is taken orally, which limits the reward associated with nonoral routes of administration. From an administrative or regulatory perspective, additional regulation may prevent misuse. For example, in 2014, hydrocodone combination products (Vicodin) were moved to a schedule II category drug by the DEA, resulting in stricter prescribing and dispensing requirements. Additional research is ongoing regarding medications that target alternative pathways, such as the endocannabinoid system, and further research is needed to improve the treatment of chronic pain and to better identify patient-level risk factors that contribute to the development of SUD (FDA, 2021). Many screening tools were created to identify patients at risk for problematic substance use, but most focus on predicting concerning behaviors rather than confirmed misuse, and their accuracy has been limited by insufficient high-quality research. These tools include:

• Tobacco, Alcohol, Prescription Medication, and Other Substance Use Tool (TAPS)—a self-administered tool that combines screening and, if positive, a brief assessment for adult patients;
• Screening to Brief Intervention (S2BI) and Brief Screener for Alcohol, Tobacco, and Other Drugs (BSTAD; NIDA, 2023a; Rosenquiest, 2026)

As previously stated, periodic review of the state’s PDMP (and possibly neighboring state's, depending on proximity to the state line), pill counts, and UDTs may also be an important aspect of screening and monitoring for misuse. Also, the prescriber should talk with the patient about their pain, treatment plan, and current medication usage. The importance of facilitating any questions and concerns using open-ended questions and nonjudgmental language cannot be understated (Becker & Starrels, 2026; Horn et al., 2026).

Some red flags may suggest that a patient is misusing or diverting controlled substances, including rapid escalation in medication requirements, frequent or unscheduled refill requests, repeated reports of lost or stolen prescriptions, obtaining medications from multiple providers or pharmacies, resistance to nonopioid or nonpharmacologic treatment approaches, and frequent after-hours calls or emergency department visits that result in prescriptions. Prescribers should remain aware of the common pitfall of assuming that well-known or well-liked patients are at a lower risk for misuse. Patients who repeatedly delay definitive or corrective procedures and instead continue long-term medication management for otherwise treatable conditions should also be monitored closely. In patients exhibiting concerning or aberrant medication-related behaviors, evidence supports offering or prescribing naloxone (Narcan) as a harm-reduction strategy to reduce overdose risk. Clinicians should routinely discuss naloxone (Narcan) availability with all patients receiving opioids and strongly consider providing it to those at increased risk, including patients receiving higher opioid doses, individuals using BZDs or other CNS depressants, those with a history of SUD or prior overdose, and patients with household members or close contacts, such as children, who may be at risk for accidental ingestion. Naloxone (Narcan) should also be considered for high-risk individuals, even if they are not currently prescribed opioids, including patients receiving medications for OUD. Education should include both the patient and household members and focus on recognizing overdose signs and proper naloxone (Narcan) use. When concerning behaviors are identified, referral to pain management or addiction specialists should be carefully considered, and if referral is not pursued, the rationale should be clearly and thoroughly documented (FDA, 2020; Horn et al., 2026; Rosenquist, 2026).

Awareness of the signs and symptoms of SUD enables the APRN to recognize patients, coworkers, or family members who may be affected by addiction. These signs and symptoms may include:

• increased agitation or irritability
• personality changes
• lack of energy or motivation
• changes in behavior (sudden insistence on privacy, being secretive, different friends)
• engaging in illegal or unsafe behaviors to obtain the substance
• conjunctival irritation (red or bloodshot eyes)
• dilated or constricted pupils
• abrupt changes in weight
• sudden change in appearance and hygiene (lack of interest in clothes, grooming)
• slurred speech, tremors, impaired coordination
• a need to use the substance regularly
• an obsession with protecting or maintaining a steady supply of the substance
• financial issues, spending large amounts of money to obtain the substance without regard for the availability of those resources, requests for money without an explanation, reports of missing cash or valuable personal items from those around the user
• dropping grades (adolescents) or poor performance at work (adults)
• engaging in high-risk behavior while under the influence of the substance, such as driving (Dugosh & Cacciola, 2026; NIDA, 2021; Office of Addiction Services and Supports, n.d.)

Overdose Management

              Naloxone (Narcan) is an opioid antagonist that blocks opioids from binding to and activating mu-opioid receptors in the CNS and can be used as a reversal/rescue drug in the case of an opioid overdose. It has a rapid onset of action and may require repeat dosing, as its duration of effect is often shorter than that of many opioids. Naloxone can reverse an overdose from prescription opioids, heroin, and the opioid component of drugs such as tramadol (Ultram), although it does not address non-opioid effects and may increase seizure risk in tramadol (Ultram) toxicity. Naloxone (Narcan) is available via intranasal and intramuscular routes and should be offered to patients at increased overdose risk, their caregivers, and household members. Education regarding overdose recognition and naloxone administration is essential. Although naloxone does not reverse overdoses caused by alcohol, BZDs, or stimulants, it is a critical harm-reduction tool for patients at risk of opioid overdose. Administration of naloxone (Narcan) may cause signs and symptoms of opioid withdrawal, including sweating/chills, nausea, vomiting, agitation/anxiety, fever, rhinorrhea (runny nose), lacrimation (watery eyes), hypertension, shivering/shaking, yawning, dilated pupils, piloerection (involuntary erection of body hairs), and muscle aches. Prescribers should consider this safety option in patients currently taking a high dose of opioids, chronic opioids (greater than 3 months), concurrent opioids and BZDs, current ongoing treatment for SUD, history of opioid misuse or overdose, or immediate family members with a history of opioid misuse or overdose. A naloxone (Narcan) prescription should also be considered during periods of transition from one opioid to another in case of accidental overdose. Patients in secluded rural settings or those with chronic respiratory disease, current alcohol use, renal disease, hepatic disease, cardiac disease, HIV/AIDS, or depression/antidepressant medication use are also considered good candidates for naloxone (Narcan) rescue prescriptions. Naloxone (Narcan) prescriptions should also be granted to caregivers who request them. Since 2023, naloxone (Narcan) has been available over the counter in the United States without a prescription, which has significantly increased access for patients, caregivers, and bystanders. It is important that patients, as well as family members and caregivers, are educated on the signs/symptoms of an opioid overdose, such as snoring or choking sounds, shallow respirations, unresponsiveness, bradycardia, hypotension, and pale, clammy skin that may be blue or gray. The benefits of overdose reversal are thought to outweigh the risks during pregnancy. It is excreted in small amounts in breast milk but has poor oral bioavailability, leading to minimal infant exposure (SAMHSA, 2025d; Stolbach & Hoffman, 2025, 2026; UpToDate Lexidrug, n.d.-c). In suspected BZD overdose, supportive care is the mainstay; flumazenil (Romazicon) is rarely indicated and should only be administered by experienced providers in carefully selected cases (Park, 2026).

Termination of Chronic Opioid Therapy

If, at any point, the risks or harm outweigh the potential benefits, opioids should be tapered to a lower dose or gradually discontinued and other treatments optimized (Dowell et al., 2022). As with treating any medical condition, the goal is to restore health and resume preillness activities of daily living; the same is true for the termination of chronic opioid therapy. Discontinuation is an intentional, patient-centered process that occurs when a patient has achieved most of the treatment goals and/or when therapy must end for other reasons. According to the HHS Working Group on Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics (2019a), the prescriber should continue tapering and/or discontinuing opioid therapy if the following conditions are met:

• the patient’s pain (or targeted symptom) has improved
• the patient desires to reduce their dose or wean off the medication
• the goals of treatment (less pain, enhanced function) have not been met or are unattainable, despite adherence to treatment and/or escalating doses
• the risk-benefit ratio is no longer favorable to continue treatment (should be reassessed quarterly)
• there is evidence of substance misuse, diversion, or nonadherence to treatment agreements
• the side effects related to the medication are intolerable (i.e., decreased QOL or worsened function)
• the patient has indications of impending overdose (i.e., sedation, confusion, speech changes)
• the patient experiences an overdose resulting in medication reversal or hospitalization
• the patient has new risk factors that increase their potential for an adverse effect (i.e., a medical condition such as sleep apnea or liver/kidney dysfunction, a new prescription for another CNS depressant)

Studies indicate that most patients who voluntarily reduce their long-term opioid use experience better function, mood, sleep, anxiety, and no change in pain levels. This should not be encouraged if the benefits of therapy continue to outweigh the potential harms (HHS, 2019a). Dosages above the reported benefit level for most patients do not have to be reduced in all patients simply because they are high. The risks of continued long-term substance use should be clearly outlined with the patient and family to promote shared decision-making. Comorbid mental health conditions must be treated to enhance the likelihood of success when tapering controlled substances, so patients should be screened before initiating a taper. Patients with risk factors or red flags for SUD should be formally screened. The prescriber should directly address their concerns with the patient, allowing them the time and space to mirror or further discuss their own concerns. If the screening tool indicates OUD/SUD, treatment should be offered and initiated (HHS, 2019a; Pisansky et al., 2026). The following strategies for collaborative tapering of controlled substances may be helpful:

• utilize open, honest communication and dialogue with the patient from the point of the initial consultation
• set realistic, measurable goals for treatment that reflect the patient’s objectives
• allow the patient to participate in shared decision-making regarding a taper—which medications, which dosages, and a targeted timeline
• taper slowly to minimize opioid withdrawal; the longer the patient has been on opioids, the longer it will take for a successful taper
• avoid terminating the relationship when a patient is in crisis without referral to a specialized facility, as this can lead to severe psychological distress and suicidal thoughts/intent
• provide support (reassurance and encouragement) and information about other available resources (i.e., community resources, support groups, nonpharmacological pain modalities), and document that resources have been provided (Pisansky et al., 2026)

The evidence regarding best practices in tapering long-term opioid use in patients with chronic, noncancer pain is not robust. Most recommend a modest reduction in dosage (5%–20%) every 4 weeks. A patient who has been on opioid medications for a year or more may require a 10% (or less) reduction every month to avoid withdrawal symptoms. Some patients can tolerate a faster taper (10% every 1–2 weeks until 30% of the original dose remains, followed by 10% weekly). The CDC cautions against routine fast tapers. Faster tapers should be used only when clinically necessary (e.g., serious adverse events). Once the patient is taking the smallest dose available, the interval between doses can be extended. Discontinuation may be considered once patients reach very low or intermittent doses, but individual response and withdrawal risk must still be assessed. A temporary hold (or pause) during a taper may allow extra time for a patient to adjust to a new dose and ease symptoms. In rare cases involving serious, ongoing safety risks, a more rapid taper over weeks may be necessary, with close monitoring and support. Weekly or monthly follow-up visits during a substance taper are typically beneficial. The patient may not need to discontinue the substance completely, but reduce their dose until the benefits of therapy again outweigh the potential harm. The taper’s goals (and how success will be measured) should be agreed upon before tapering in collaboration with the patient, just as before initiating therapy with the controlled substance (Dowell et al., 2022; HHS, 2019a; Pisansky et al., 2026).

A slow, gradual taper helps minimize opioid withdrawal symptoms, and patients should be fully educated about expected symptoms and coping strategies to reduce anxiety and distress. Early withdrawal symptoms, such as yawning, anxiety, restlessness, myalgias, sweating, and GI upset, typically improve within 5–10 days, whereas symptoms such as irritability, insomnia, and dysphoria may persist for weeks or months. Autonomic symptoms, including sweating and tachycardia, may be managed with α-2 adrenergic agonists such as clonidine (Catapres), lofexidine (Lucemyra), or tizanidine (Zanaflex), while other symptoms can be treated symptomatically (e.g., trazodone [Desyrel] for insomnia, NSAIDs or acetaminophen [Tylenol] for myalgias, and loperamide [Imodium] or bismuth subsalicylate [Pepto-Bismol] for diarrhea). For patients unable to tolerate tapering or when OUD is suspected, transition to a partial opioid agonist such as buprenorphine (Sublocade) or referral to an addiction-trained provider may be appropriate. Interdisciplinary rehabilitation programs often incorporate pain management as part of comprehensive care. Patient characteristics associated with greater tapering difficulty include long-term opioid use, higher pain scores prior to tapering, anxiety related to withdrawal, psychiatric comorbidity, female sex, and older age (Pisansky et al., 2026).

              In addition to the risks of continued substance use, the patient should be counseled on the potential dangers of tapering or discontinuing the substance. The risks associated with a rapid or abrupt tapering of controlled substances vary by substance. Opioid withdrawal, increased pain, insomnia, anxiety/depression, and thoughts of suicide may result from an opioid taper. Abrupt opioid withdrawal during pregnancy increases the risk for spontaneous abortion (miscarriage) and premature (preterm) labor. Anxiety, hallucinations, seizures, and death may characterize BZD withdrawal. The risk of overdose increases within a week of tapering or discontinuing opioids or other sedating substances due to a rapid loss of tolerance. If the patient were to resume their original dose, they might overdose quickly and easily without intention. Patients tapering or discontinuing their medications should be counseled extensively regarding this risk and the signs/symptoms of overdose. A prescription for naloxone (Narcan) should be considered in these patients (HHS, 2019a; Pisansky et al., 2026).

Diagnosis and Treatment of SUD and Addiction

The diagnosis of SUD is a clinical one based primarily on a thorough patient history. The APA’s Diagnostic and Statistical Manual (5th Edition, Text Revision) lists 11 different criteria for the diagnosis of SUD. Mild SUD is diagnosed when a patient has two to three criteria met, moderate SUD is diagnosed when four to five are met, and severe SUD is diagnosed when six or more are met (APA, 2022). SUD is defined as a problematic repetition or habit of ingesting/administering an intoxicating substance that causes substantial anguish or drastically affects the patient’s ability to function professionally, socially, or otherwise. These effects are evidenced by two or more of the conditions listed here within 1 year:

• ineffective attempts to reduce the use of the substance or a wish to do so
• an intense need or impulse to use the substance
• a persistent ingestion/administration of the substance even though they have experienced repeated relational challenges (i.e., with surrounding friends and family members) related to its use
• a persistent ingestion/administration of the substance in environments where it is unsafe
• the development of tolerance, which is a gradual reduction in the physical impact/effect of a given substance when administered at a consistent dose or amount, requiring an increase in dose or amount to achieve the prior effect (not applicable when medications are taken as prescribed under appropriate medical supervision)
• a persistent ingestion/administration of the substance for a longer time and at a higher dose or amount than planned
• a considerable investment of time related to the substance, procuring it, ingesting/administering it, or recuperating from the consequences of its use
• a persistent ingestion/administration of the substance, interfering with significant responsibilities and commitments (i.e., academic, professional, or familial)
• a decrease in attendance or participation in significant events at work, at home, or with friends/family due to the use of the substance
• a persistent ingestion/administration of the substance even though they are aware of a significant challenge directly related to the substance use
• the development of withdrawal as evidenced by the signs and symptoms of withdrawal syndrome for that particular substance or the use of the substance to prevent these symptoms (APA, 2022)

The disorder may be considered in early (3 or more months) or sustained (12 or more months) remission when all of the above symptoms have resolved, except for an intense need or impulse to use the substance. This may also be qualified in a controlled environment if the patient currently lacks access to the substance (APA, 2022).

Brief intervention (BI) is an appropriate engagement strategy for many patients with risky substance use or mild to moderate SUD. It encourages the patient to recognize the problem with substance use and engage them in positive change. It typically lasts 5–15 minutes and consists of brief advice via motivational interviewing techniques. The FRAMES acronym is a commonly used method:

• Feedback of risk,
• Encouraging responsibility for change,
• Advice,
• A menu of options,
• Therapeutic empathy,
• Enhancing self-efficacy (Bradley, 2025)

BI is a component of screening, brief intervention, and referral to treatment (SBIRT), an evidence-based method of screening patients and briefly providing education and/or motivation to change, with an associated referral for additional treatment. SBIRT is meant to be brief, universal, comprehensive, targeted, and performed outside a substance misuse treatment setting. SBIRT begins with a validated screening tool to assess risk, which provides the basis for the feedback of risk (step #1 above). The brief counseling session should explore ambivalence, enhance motivation, and facilitate shared goal setting (if applicable) by first defining healthy patterns of use/behavior and then drawing a clear distinction with the patient’s current use/behavior in a nonjudgmental manner. The discussion should be collaborative, with questions regarding how the patient perceives any benefits and potential risks of their substance use. Abstinence is not required as an initial goal, but patient readiness for change should be explored. If yes, the provider may ask the patient to gauge their motivation using a 1–10 scale. A patient who is unwilling or not yet ready to make a behavioral change should be treated with respect and dignity and reassessed later. A comprehensive substance-related history should be completed if the above screening tools are positive, with questions regarding onset, duration, characteristics, precipitating factors, other substances used, and withdrawal symptoms (Bradley, 2025; SAMHSA, 2024a).

Goal setting is associated with improved treatment outcomes, as are nonpharmacological lifestyle changes such as establishing consistent sleep routines, engaging in regular physical activity, avoiding or developing coping strategies for triggers, pursuing new hobbies to reduce boredom, and strengthening relationships with supportive friends and family members. Both inpatient and outpatient treatment programs should be considered based on individual patient needs and may include a combination of addiction counseling, behavioral therapies, group therapy, psychotherapy, and social service support. For the treatment of most SUDs, CBT has been proven effective. CBT attempts to modify the patient’s unhealthy thought and behavior patterns as well as develop strategies to manage cravings and avoid triggers. Some forms of therapy also provide incentives for abstinence. Behavioral treatments may involve the individual and the family or occur in a group setting. The goal is to improve relationships and functionality at work, home, and community. Motivational incentives (contingency management), designed to use positive reinforcement to encourage abstinence, may also be used (McKay, 2026; NIDA, 2023b).

Medication options for OUD treatment include buprenorphine (e.g., sublingual buprenorphine/naloxone [Suboxone] and ER formulations such as Sublocade), methadone (Methadose), and naltrexone (Vivitrol, Revia). Buprenorphine (Sublocade) is a partial opioid agonist, methadone (Methadose) is a full agonist, and naltrexone (Vivitrol) is an antagonist. Buprenorphine (Sublocade) and methadone (Methadose) have stronger evidence for better outcomes, including reduced overdose deaths and all-cause deaths. They also do not require abstinence (refer to the naltrexone [Vivitrol] section for abstinence recommendations) and are more commonly used than naltrexone. Most nonprescribed buprenorphine (Sublocade) use is associated with attempts to self-manage withdrawal and cravings, and its partial agonist properties limit euphoric effects and misuse potential. Diversion of methadone (Methadose) prescribed for OUD is relatively uncommon due to the regulatory structure of opioid treatment programs, and when it occurs, it is often linked to efforts to alleviate withdrawal in individuals without access to treatment. Studies indicate that buprenorphine (Sublocade) and methadone (Methadose) are equally effective when used at adequate doses. A direct comparison of naltrexone ER (Vivitrol) and buprenorphine/naloxone (Suboxone) showed the two are similarly effective once detoxification is complete and treatment has been initiated; however, fewer patients are able to initiate naltrexone due to the requirement for complete opioid abstinence (HHS, 2019b; NIDA, 2025; Strain, 2026b).

Buprenorphine (Sublocade) is a semisynthetic partial opioid agonist (binds to receptors but only partially activates) that reduces cravings. It may cause mild euphoria in some patients, but it is designed with the aforementioned ceiling effect to limit the misuse potential. It may also cause respiratory depression when combined with BZDs or other CNS depressants. There are a few types of buprenorphine approved for use by the FDA, which include a monthly subcutaneous injection (Sublocade), a subdermal implant that lasts for 6 months (Probuphine), buprenorphine/naloxone (Bunavail, Suboxone) sublingual or buccal film, buprenorphine/naloxone (Zubsolv and generic) sublingual tablets, and buprenorphine sublingual tablets (Subutex). The injection is an LA depot formulation with an apparent half-life measured in weeks. The combination products are used most often, as the addition of naloxone effectively blocks attempts at misuse. The naloxone component, an opioid antagonist, is not well absorbed through the oral mucosa. However, if the tablets/films are crushed or melted for injection or any other delivery method, the naloxone component blocks the effects of the opioid. The sublingual products of buprenorphine (Subutex) are LA agents and require only daily dosing for many patients. Diversion concerns primarily involve these transmucosal formulations (Subutex), as some patients may divert the drug or combine it with a BZD to augment the euphoric effects, a potentially lethal combination. Random UDTs may help screen for and identify patients mixing other medications or diverting/selling their prescription and not taking it at all. Consistent use of available PDMPs will also help the prescriber recognize patients obtaining prescriptions elsewhere. Overdoses are rare, and buprenorphine (Sublocade) is associated with substantially lower overdose risk than methadone (Methadose) due to its ceiling effect on respiratory depression. Due to its high affinity for the mu-opioid receptors, it should ideally be started when the patient is experiencing early stages (12–24 hours) of mild to moderate withdrawal (score of 6–12 on the scale). Home-based or unobserved treatment inductions supported by extensive patient education and preparation are possible and becoming more common. Common side effects include GI symptoms (e.g., nausea, vomiting, constipation), headache, dizziness, drowsiness, dry mouth, tooth decay, muscle aches/cramps, insomnia, fever, visual changes (e.g., blurry or dilated pupils), tremors, palpitations, and lack of attention. Tooth decay is only a concern for the sublingual/buccal formulations. Serious side effects may include overdose with respiratory depression/distress, adrenal insufficiency, dependence, withdrawal, and NOWS/NAS in infants. The implant may cause pain, itching, and edema at the implant site, and the injection may cause injection site reactions/pain (SAMHSA, 2026; Strain, 2026b).

A specialty waiver is no longer required to prescribe buprenorphine (Sublocade) for OUD treatment. The Mainstreaming Addiction Treatment (MATE) Act, enacted as part of the Consolidated Appropriations Act of 2023, removed the DATA 2000 (X-waiver) requirement previously needed to prescribe buprenorphine for OUD. As a result, any clinician registered with the DEA and authorized by state law to prescribe controlled substances may now prescribe buprenorphine products for OUD, including LA formulations such as Sublocade. The legislation also eliminated federal patient caps that previously limited the number of individuals a prescriber could treat with buprenorphine (SAMHSA, 2024b).

Methadone (Methadose) is administered for OUD exclusively through SAMHSA-certified opioid treatment programs (OTPs) and is not available for office-based prescribing for OUD. It is a synthetic full opioid agonist that has been used for several decades to help limit symptoms of withdrawal/cravings. It has a variable and prolonged half-life (approximately 8–60 hours or longer), and steady-state plasma levels may take 3–5 days to achieve. Patients with hepatic disease may have delayed clearance and subsequently increased plasma levels. Methadone (Methadose) produces physical dependence and requires careful monitoring due to overdose risk. SAMHSA oversees the accreditation and certification of OTPs, and providers must register with both SAMHSA’s Center for Substance Abuse Treatment and the DEA. It is available as a diskette, liquid, or powder form. Patients with a history of opioid misuse for at least 1 year or who are currently at high risk due to pregnancy or recent release from prison or a similar institution qualify for treatment with methadone (Methadose). Common side effects include nausea/vomiting, constipation, hyperhidrosis (increased sweating), restlessness, bradypnea, and urticaria. Serious risks include respiratory depression, overdose, anaphylaxis, angina, tachycardia, hallucinations, and QTc prolongation. Cardiovascular monitoring during long-term use may be beneficial. The initial dose of methadone (Methadose) is typically 20–30 mg, with total first-day dosing not exceeding 40 mg. Maintenance dosing will vary from patient to patient, typically 60–120 mg. Adequate dosing, often at higher therapeutic ranges, is associated with improved retention and reduced relapse. Methadone (Methadose) is relatively safe during pregnancy and breastfeeding. Short-term treatment (less than 12 months) is associated with high relapse risk; duration should be individualized, and many patients benefit from long-term or indefinite maintenance (Chang & Welsh, 2026; SAMHSA, 2025b; Strain, 2026b).

Naltrexone (Vivitrol) is an opioid antagonist (prevents opioids from binding to/activating receptors) used for OUD and alcohol use disorder (AUD) treatment. It is available as an LA injection every 4 weeks, can be prescribed by any licensed prescriber, and has minimal misuse or diversion potential, particularly in its ER injectable form (SAMHSA, 2025c). Before starting naltrexone (Vivitrol), the patient should be opioid-free for 7–10 days to prevent opioid withdrawal syndrome, which is a treatment initiation challenge. Despite its convenient delivery method and the fact that any licensed prescriber can prescribe it, it is used less commonly than methadone (Methadose) and buprenorphine (Sublocade) for the treatment of OUD. Naltrexone (Vivitrol) is generally not appropriate for patients who require opioid analgesia, limiting its use in those with significant pain. ER naltrexone (Vivitrol) has comparable effectiveness to buprenorphine-based treatment among patients who are able to complete withdrawal and initiate therapy; however, fewer patients are able to successfully start naltrexone due to the initial abstinence requirement (HHS, 2019b; SAMHSA, 2025c; Strain, 2026b).

For individuals with BZD or barbiturate use disorder, abrupt discontinuation should be avoided because withdrawal can be severe and, in some cases, life-threatening. Detoxification from these CNS depressants often requires medical supervision, particularly in patients with chronic or high-dose use. BZD withdrawal may manifest as cravings, tremors, anxiety, agitation, insomnia, perceptual disturbances, hallucinations, autonomic instability (e.g., tachycardia, hypertension, hyperthermia), hyperreflexia, and seizures. Patients should be screened for cooccurring psychiatric conditions, and treatment of these conditions should be optimized to improve engagement and outcomes during SUD treatment. Current clinical practice guidelines by the American Society of Addiction Medicine (2025) recommend a slow, individualized tapering approach, frequently achieved by transitioning patients to a longer-acting BZD such as diazepam (Valium) or chlordiazepoxide (Librium) prior to dose reductions. Initial tapering typically involves 5%–10% dose reductions every 1–2 weeks, with the pace adjusted based on withdrawal severity, duration of prior use, and patient tolerance. Tapering often extends over several months, and temporary pauses or further slowing may be required if symptoms worsen. Withdrawal severity can be monitored using structured tools such as the Clinical Institute Withdrawal Assessment–Benzodiazepines (CIWA-B). Pharmacologic management prioritizes BZDs themselves as first-line therapy. Phenobarbital-based protocols may be considered in closely monitored inpatient settings for severe or refractory withdrawal, but require clinical expertise due to a narrow therapeutic index and risks including oversedation and respiratory depression. Flumazenil (Romazicon) is generally not recommended for routine BZD withdrawal management because it may precipitate seizures in BZD-dependent patients. Adjunctive treatments such as melatonin for insomnia may provide symptomatic relief, and behavioral therapies, including CBT, are recommended to support long-term recovery from sedative-hypnotic use disorders (Brunner et al., 2025; Park, 2026).

Stimulant withdrawal can be uncomfortable, although it is generally less medically dangerous than withdrawal from CNS depressants. Withdrawal signs and symptoms may include fatigue, sleep disturbances, increased appetite, agitation, bradycardia, and slowed motor activity, and typically occur within hours to days following stimulant cessation (ANA, 2022). Initial management of SUD focuses on psychosocial interventions, such as individual or group drug counseling for mild SUD, and intensive outpatient treatment incorporating contingency management for moderate to severe presentations. Motivational interviewing is also commonly integrated into treatment. Although several pharmacologic agents have been studied as adjunctive treatments for cocaine and methamphetamine use disorders, none are FDA-approved, and these agents are not indicated for the treatment of misuse of prescribed stimulants (Kampman, 2026). Management should include reassessment of the original indication for stimulant therapy (e.g., ADHD), evaluation for comorbid psychiatric conditions, and determination of whether continued stimulant treatment is clinically appropriate. When discontinuing a prescribed stimulant medication, gradual tapering is often recommended to reduce rebound symptoms; however, tapering is not routinely used for illicit stimulant withdrawal. If stimulant discontinuation is necessary, nonstimulant alternatives may be considered for treatment of underlying conditions (e.g., ADHD), such as atomoxetine (Stratter), viloxazine (Qelbree), and bupropion (Wellbutrin). If stimulant therapy is continued, risk-mitigation strategies noted above for other controlled substances, such as frequent follow-up, pill counts, UDTs, and routine PDMP review, should all be considered. Treatment should also address any underlying psychiatric disorders or misuse of other substances (Becker & Starrels, 2026; Brent et al., 2026).

Federal MATE Act Training

The MATE Act, enacted as part of the Consolidated Appropriations Act of 2023, was designed to expand access to evidence-based treatment for SUDs and to strengthen clinician preparedness in managing opioid and other substance-related conditions. Effective June 27, 2023, the Act eliminated the former DATA “X-waiver" (as mentioned above) while simultaneously requiring most DEA-registered practitioners (excluding veterinarians) to attest to completing at least 8 hours of training in the treatment and management of opioid or other SUDs, or in the safe pharmacologic management of pain and related screening and referral practices. This training may be completed cumulatively and through various accredited organizations, or satisfied through qualifying board certification or recent graduation from approved medical, nursing, or physician assistant programs. Importantly, the MATE Act establishes a one-time training requirement tied to DEA registration or renewal. While the MATE Act establishes a national baseline for training and prescribing authority, several states maintain additional or differing requirements—such as scope-of-practice rules, state-specific continuing education mandates, or prescribing regulations—which clinicians must also follow to remain compliant (DEA Diversion Control Division, 2023; SAMHSA, 2026).

Specific Rules and Regulations for the State of New York

All prescribers licensed under Title Eight of the Education Law in New York to treat humans and who have a DEA registration number to prescribe controlled substances, as well as medical residents who prescribe controlled substances under a facility DEA registration number, must complete at least 3 hours of coursework or training in pain management, palliative care, and addiction every 3 years. The Rules and Regulations on Controlled Substances in NYS (Part 80) specifies that:

• Physicians and other authorized practitioners, in the course of their professional practice, may dispense, administer, or prescribe controlled substances for legitimate medical purposes or treatment other than treatment intended solely to maintain addiction to controlled substances, when the practitioner regulates the dosage and prescribes or administers a quantity of such drugs no greater than that ordinarily recognized by members of their profession as sufficient for proper treatment in a given case. Such practitioners shall maintain a written patient record of administering, dispensing, and prescribing all controlled substances. The patient record shall contain sufficient information to justify the diagnosis and warrant the treatment. The record shall include at least the following information: patient identification data; chief complaint; present illness; physical examination as indicated; diagnosis; other data which support the diagnosis or treatment; and the regimen, including the amount, strength, and directions for the use of the controlled substance. This subdivision shall not be construed to require a record distinct from the patient's medical record (NYSDoH, 2025b, Section 80.62).
• The use of preprinted prescriptions that indicate the controlled substance or the strength, dosage, and/or quantity of the controlled substance is prohibited. Such prohibition shall not apply to printed prescriptions generated using a computer or an electronic medical record system, provided such printed prescriptions are generated when a practitioner prescribes a controlled substance for a patient (NYSDoH, 2025b, Section 80.63).
• No such prescription shall be made for a quantity of substances exceeding a 30-day supply if the substance were used per the directions for use specified on the prescription unless an applicable statutory exception code is used. A practitioner may issue no additional prescriptions for a controlled substance to an ultimate user within 30 days of the date of any prescription previously issued unless and until the ultimate user has exhausted all but a 7-day supply of that controlled substance provided by any previously issued prescription. A practitioner may issue a prescription for up to a 3-month supply of a controlled substance, including chorionic gonadotropin, or up to a 6-month supply of an anabolic steroid if used per the directions for use, provided that the prescription has been issued for the treatment of:

• panic disorders (code A)
• attention deficit disorder (code B)
• chronic debilitating neurological conditions characterized as a movement disorder or exhibiting seizure, convulsive, or spasm activity (code C)
• relief of pain in patients suffering from conditions or diseases known to be chronic or incurable (code D)
• narcolepsy (code E)
• hormone deficiency states in male patients, gynecologic conditions that are responsive to treatment with anabolic steroids or chorionic gonadotropin, metastatic breast cancer in female patients, anemia, and angioedema (code F; NYSDoH, 2025b, Section 80.67)

• No refills are allowed on schedule II medications or BZDs under New York law, even though BZDs are classified as schedule IV under federal law. For non-BZD schedule III–V controlled substances, no more than five refills are allowed (NYSDoH, 2025b, Section 80.67 and 80.69).
• Emergency prescriptions may be called into pharmacies by prescribers for schedule II medications or BZDs for no more than a 5-day supply, as long as the official written or electronic prescription is delivered to the pharmacist within 72 hours. For schedule IV (except BZDs) medications, this limit is a 30-day supply, or quantity #100, whichever is less (NYSDoH, 2025b, Section 80.68 and 80.70).
• Before prescribing for or dispensing to a patient any controlled substance listed on schedule II, III, or IV of section 3306 of the public health law, every practitioner shall consult the prescription monitoring program registry to review that patient’s controlled substance history. The patient’s controlled substance history shall be obtained from the prescription monitoring program registry no more than 24 hours before the practitioner prescribes or dispenses any controlled substance to that patient. A practitioner shall document such consultation in the patient’s medical chart, or if the practitioner does not consult the prescription monitoring program registry, the practitioner shall document in the patient's medical chart why such consultation was not performed (NYSDoH, 2025b, Section 80.63).

• A practitioner (or any prescriber) is prohibited from providing any prescriptions of controlled substances to an addict or habitual user not in the course of professional treatment but to provide the user with medication sufficient to keep them comfortable by maintaining their customary use except when prescribing FDA-approved medications for the legitimate treatment of SUD or when withdrawal would be dangerous to life (NYSDoH, 2025b, Section 80.85).
• According to New York State Public Health Law section 3331, a 7-day supply limit exists for any opioid prescriptions at an initial consultation or treatment for acute pain. Upon any subsequent consultations for the same pain, the practitioner may issue, per existing rules and regulations, any appropriate renewal, refill, or new prescription for an opioid (New York State Senate, 2025).

• Within the state of New York, naloxone (Narcan) can be accessed without a healthcare provider’s prescription, and sometimes with reduced or no out-of-pocket cost to the patient, via an authorized opioid overdose program or at a participating pharmacy via the voluntary standing order program (currently includes CVS, Duane Reade, Rite Aid, WalMart, Stop and Shop, and Walgreens, among many others; NYSDoH, 2025a).

For additional training on addiction, please refer to the NursingCE.com activity titled Substance Abuse and Addiction for APRNs.

For additional training on the effective management of pain, please refer to the NursingCE.com three-part series titled Pain Management for APRNs.

For additional training on palliative care, please refer to the NursingCE.com activity titled Palliative Care for APRNs.

For additional training on care at the end of life, please refer to the NursingCE.com activity titled Ethical Issues in End-of-Life Care.

For additional training on the management of anxiety, please refer to the NursingCE activity titled Anxiety Disorders for APRNs

For additional training on medical cannabis, please refer to the NursingCE.com course titled Medical Cannabis Nursing CE Course for APRNs

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