buprenorphine

Adjunctive therapy

Brands: Subutex

Last reviewed 2025-12-31

Reviewed by PsychMed Editorial Team.

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Quick answers

What is buprenorphine?
Buprenorphine (brand Subutex; generics) is a partial opioid agonist used to treat opioid use disorder (OUD). It can reduce withdrawal symptoms and cravings and is intended to be used as part of a comprehensive treatment plan with counseling and psychosocial support (label/guideline).
What is Subutex?
Subutex is a brand name for buprenorphine.
What is Subutex (buprenorphine) used for?
Label indications include: Opioid use disorder treatment (induction; selected maintenance scenarios) (label).
What drug class is Subutex (buprenorphine)?
Partial μ-opioid receptor agonist used for opioid use disorder (OUD) treatment; reduces withdrawal and cravings and is commonly used for induction, with transition to buprenorphine/naloxone preferred for unsupervised maintenance when appropriate (label/guideline).
What strengths does Subutex (buprenorphine) come in?
Sublingual tablets (label): buprenorphine 2 mg and 8 mg.

Snapshot

Class: Adjunctive therapy
Common US brands: Subutex
Therapeutic drug monitoring not routinely recommended.
Last reviewed: 2025-12-31

Label indications

Opioid use disorder treatment (induction; selected maintenance scenarios) (label).

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Clinical Highlights

Buprenorphine (brand Subutex; generics) is a partial opioid agonist used to treat opioid use disorder (OUD). It can reduce withdrawal symptoms and cravings and is intended to be used as part of a comprehensive treatment plan with counseling and psychosocial support (label/guideline). A key safety/implementation point is buprenorphine induction timing: starting too soon after recent opioid use can trigger precipitated withdrawal. The label recommends initiating when there are objective signs of moderate opioid withdrawal (label).

Sublingual buprenorphine tablets do not contain naloxone. Labeling describes the monoproduct as preferred during induction, with buprenorphine/naloxone generally preferred for unsupervised maintenance because the naloxone component can deter injection misuse (label/clinical).
Like other opioids, buprenorphine can cause respiratory depression, especially when combined with alcohol, benzodiazepines, or other CNS depressants. Many care plans include take-home naloxone access for opioid overdose emergencies (label/guideline).
Systematic-review and guideline evidence supports buprenorphine-based treatment for improving retention and reducing illicit opioid use compared with placebo/no medication (review/guideline).
The compare view, buprenorphine evidence feed, and buprenorphine print page support shared decision-making when opioid use disorder treatment is discussed alongside anxiety, sleep disruption, and co-prescribed sedatives.

Dosing & Formulations

Sublingual tablets in two strengths: buprenorphine 2 mg and 8 mg (label). Induction is individualized to opioid type and dependence severity. For short-acting opioids, labeling recommends the first dose only once moderate withdrawal is present and not less than 4 hours after the last opioid use (label).

During induction, dosing may be given in 2 mg to 4 mg increments based on symptoms (label).
After stabilization, the label describes a typical maintenance range of 4 mg to 24 mg per day, with a target of 16 mg once daily; doses above 24 mg have not been shown to provide additional clinical benefit (label).
When transitioning from methadone, labeling emphasizes a higher risk of precipitated withdrawal at higher methadone doses and with short intervals since the last methadone dose; induction plans are often individualized (label/clinical).

Monitoring & Risks

Sedation and respiratory depression risk increases with concurrent CNS depressants (alcohol, benzodiazepines, sedative sleep agents). Clinical monitoring typically includes overdose risk review and avoidance of combining sedatives when possible (label/clinical). Precipitated withdrawal is the key early risk; clinicians often document the withdrawal assessment and induction plan, especially when fentanyl exposure is suspected (label/clinical).

Transmucosal buprenorphine has been associated with dental problems (caries, infections, tooth loss). Counseling about rinsing and oral hygiene is commonly included (label/clinical).
Diversion and misuse remain possible. Follow-up intensity and prescription quantities are commonly adjusted to stability and safety considerations (label/clinical).
If buprenorphine is stopped, tolerance can drop and overdose risk can rise if opioids are resumed; relapse prevention planning is part of longitudinal care (clinical).

Drug Interactions

CNS depressants (benzodiazepines, alcohol, sedatives) can increase respiratory depression risk when combined with buprenorphine (label/clinical). CYP3A4 inhibitors can increase buprenorphine exposure and CYP3A4 inducers can decrease exposure, which can affect opioid effects and withdrawal control; medication list review is important when antiretrovirals, certain antifungals, or anticonvulsants are present (label/clinical).

Buprenorphine blocks other opioids’ effects to some degree; pain management plans for procedures or acute injury often require advance coordination (clinical).

Practice Notes

Guidelines generally recommend offering medication for opioid use disorder (MOUD) (buprenorphine or methadone) because it improves treatment engagement and reduces illicit opioid use compared with non-medication approaches (guideline/review). The monoproduct is commonly reserved for induction or for scenarios where naloxone-containing formulations are not tolerated; long-term maintenance is often done with buprenorphine/naloxone when appropriate (label/clinical).

Follow-up typically focuses on withdrawal control, cravings, ongoing opioid use, and safety (sedatives, overdose risk). Many clinicians also integrate harm-reduction counseling and naloxone access planning (clinical).

References

Buprenorphine Sublingual C III Tablet Prescribing Information — DailyMed (2024)
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)