buprenorphine naloxone
Last reviewed 2026-02-12
Reviewed by PsychMed Editorial Team.
Brands: Suboxone
Sources updated 2026 • 4 references
General Information
Buprenorphine-naloxone (brand Suboxone; generics) is a combination medication used to treat opioid use disorder (OUD) (label).
Buprenorphine is a partial μ-opioid receptor agonist that reduces withdrawal and cravings; naloxone is included primarily to discourage injection misuse (low bioavailability with sublingual use) (label).
Buprenorphine induction timing is clinically important because starting too soon after recent opioid use can trigger precipitated withdrawal; programs typically use structured induction approaches aligned with objective withdrawal (label/guideline).
Safety planning often focuses on sedation/respiratory depression with other CNS depressants, diversion risk, and co-occurring mental health symptoms (label/guideline).
The compare view, buprenorphine-naloxone evidence feed, and buprenorphine-naloxone print page support documentation and counseling when opioid treatment decisions overlap with anxiety, insomnia, and depression symptoms.
U.S. approvals
- Opioid use disorder treatment (label) ()
Formulations & strengths
- Sublingual film and sublingual tablets (multiple strengths) (label).
Generic availability
- Generic equivalents available in the U.S.
Often used in office-based or program-based opioid use disorder (OUD) treatment. Access, induction logistics (especially with fentanyl exposure), and co-prescribed sedatives are common determinants of safety and outcomes.
View labelExactMechanism of Action
Refer to the Glossary entry on Neurotransmitters for background on receptor systems involved in serious mental illness.
Buprenorphine is a partial μ-opioid receptor agonist with high receptor affinity; it reduces withdrawal and cravings and has a ceiling effect on respiratory depression compared with full agonists (label/guideline).
Naloxone is an opioid antagonist added to discourage parenteral misuse. With sublingual use, naloxone bioavailability is low; if injected, it can trigger precipitated withdrawal (label).
- Buprenorphine partial μ-opioid agonism (high affinity); naloxone opioid antagonism.
Metabolism and Pharmacokinetics
- Buprenorphine is metabolized primarily by CYP3A4 and by glucuronidation pathways (UGT), with elimination via feces and urine (label).
- Naloxone undergoes extensive first-pass metabolism and has low bioavailability via the sublingual route (label).
- Hepatic impairment can increase exposure; labeling includes cautions and clinicians often monitor liver-related risk when baseline disease is present (label/clinical).
Dosing and Administration
- Treatment is often structured in phases (induction, stabilization, maintenance) with dose changes guided by withdrawal symptoms, cravings, and safety (guideline/clinical).
- Induction timing is individualized by opioid type and timing of last use; objective withdrawal assessment is commonly used to reduce precipitated withdrawal risk (label/guideline).
- Follow-up frequency is often higher early in treatment and then adjusted as stability improves (guideline/clinical).
Monitoring & Labs
- Early follow-up to assess withdrawal control, cravings, sedation, and adherence (guideline/clinical).
- Review concurrent CNS depressants at each visit and reassess risk when new sedating medications are started (label/clinical).
- Monitor for diversion/misuse as clinically indicated (structured follow-up, PDMP review, urine drug testing depending on setting) (guideline/clinical).
- Consider hepatic monitoring when baseline liver disease is present or when symptoms emerge (label/clinical).
Induction and early stabilization are the highest-risk periods; programs often document induction timing decisions to reduce precipitated withdrawal risk (label/guideline).
Adverse Effects
FDA boxed warnings
Common side effects (≥10%)
- Sedation / dizziness: Can impair driving and work safety, especially early in treatment or with other sedatives (label/clinical).
- Constipation / nausea: Opioid-related GI effects can occur; management is commonly discussed as part of retention planning (label/clinical).
- Headache / sleep disturbance: Sleep disruption can reflect withdrawal recovery, co-occurring insomnia/anxiety, or medication effects; monitoring often focuses on functional impact (clinical).
Other notable effects
- Respiratory depression risk increases with alcohol, benzodiazepines, sedating sleep agents, gabapentinoids, or other opioids (label/clinical).
- Precipitated withdrawal can occur if started too soon after full agonist opioid use; induction planning is intended to reduce this risk (label/guideline).
- Diversion and misuse risks are part of routine care planning (guideline/clinical).
Interactions
- CNS depressants (alcohol, benzodiazepines, sedative-hypnotics, gabapentinoids) can increase sedation and respiratory depression risk (label/clinical).
- CYP3A4 inhibitors or inducers can alter buprenorphine exposure; regimen changes often prompt monitoring for withdrawal or over-sedation (label/clinical).
Other Useful Information
- Systematic reviews show buprenorphine maintenance improves retention and reduces illicit opioid use compared with placebo/no medication (review/guideline).
- Guidelines emphasize that medication for opioid use disorder is a core treatment and can be effective with or without formal counseling, though many people benefit from additional supports when available (guideline/clinical).
- Choice among buprenorphine, methadone, and naltrexone is typically individualized by opioid tolerance, withdrawal severity, access/logistics, and medical risk (guideline/clinical).
References
- SUBOXONE (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film prescribing information — DailyMed (2026)
- The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update — Journal of Addiction Medicine (2020)
- TIP 63: Medications for Opioid Use Disorder — SAMHSA (2021)
- Buprenorphine maintenance versus placebo or methadone maintenance for opioid dependence — Cochrane Database of Systematic Reviews (2014)
