Opioid partial agonist (μ-receptor partial agonist, κ-antagonist) Pregnancy: No adequate data in pregnancy; use only if potential benefit outweighs risk to the foetus. May cause respiratory depression in the newborn near term; long-term use in the last three months may cause neonatal withdrawal syndrome (delayed onset). Consider neonatal monitoring for several days at end of pregnancy. Breast-feeding is contraindicated.

Buprenorphine

Brand names: BuTrans (transdermal), Transtec (transdermal), Subutex (sublingual), Suboxone (with naloxone), Sublocade (depot SC monthly), Temgesic (sublingual)

Buprenorphine is an opioid used as transdermal patches for stable chronic pain and sublingually for opioid dependence (often with naloxone); it is a controlled drug.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Opioid dependence (sublingual): induction 0.8 mg to 4 mg as a single daily dose, then titrate progressively to maintenance

Route: Sublingual

Frequency: Once daily

Max: 32 mg maximum single daily dose

For opioid dependence in adults and adolescents aged 16 years or over. Induction: initial dose 0.8-4 mg as a single daily dose; begin only when objective signs of withdrawal appear (e.g. COWS score >12) and not less than 6 hours after last use of heroin/short-acting opioids. For patients on methadone, reduce methadone to a maximum of 30 mg/day first, and give the first buprenorphine dose only when objective withdrawal signs appear, generally not less than 24 hours after the last methadone dose. Maintenance: increase progressively according to clinical effect, not exceeding a maximum single daily dose of 32 mg; then reduce gradually to a lower maintenance dose when a satisfactory stabilisation period has been achieved. Tablet is held under the tongue until dissolved (usually 5-10 minutes); sublingual is the only effective and safe route. Baseline liver function tests and viral hepatitis status recommended before starting. Elderly (>65 y): safety and efficacy not established. Severe renal impairment (CrCl <30 mL/min): caution, may require dose adjustment.

Dose adjustments

Renal

Modification not generally required; caution and possible dose adjustment in severe renal impairment (creatinine clearance <30 mL/min).

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

US labelling (FDA)

Reference — US labelling, may differ from UK

Administer buprenorphine sublingual tablet sublingually as a single daily dose. (2.1) Strongly consider prescribing naloxone at the time buprenorphine sublingual tablet is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. (2.2) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablet should be undertaken when objective and clear signs of withdrawal are evident. (2.3) Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is generally initiated after two days of buprenorphine sublingual tablet titration. (2.4) Administer …

Source: US FDA prescribing information (openFDA / DailyMed), label dated 2025-02-03. Accessed 2026-06-12. US dosing and indications can differ from UK practice — use UK sources for prescribing decisions.

Contraindications

Hypersensitivity to buprenorphine or any excipient
Children and adolescents under 16 years of age
Severe respiratory insufficiency
Severe hepatic insufficiency
Acute alcoholism or delirium tremens
Breast-feeding

Side effects

Insomnia (very common)
Headache (very common)
Nausea; abdominal pain, constipation, vomiting (common)
Hyperhidrosis (very common); pain, drug withdrawal syndrome, asthenia (common)
Anxiety, depression, nervousness (common); dizziness, somnolence (common)

Interactions

Benzodiazepines — risk of death from respiratory depression when combined; use with caution
Other CNS depressants including alcohol and other opioids — additive respiratory depression; deaths reported
Methadone / other opioids — buprenorphine (partial agonist) may precipitate withdrawal in dependent patients

Clinical monograph

How it works

It is a partial agonist at opioid (mu) receptors with high receptor affinity, giving a degree of ceiling on respiratory depression but firm receptor binding.

Prescribing in practice

Because of its high affinity and partial agonism, it can precipitate withdrawal if given too soon to someone dependent on full opioid agonists — timing matters in dependence treatment.
Patches are for opioid-tolerant patients with stable pain; heat increases absorption.
Respiratory depression is still possible, especially combined with sedatives; counsel on dependence and safe storage.

Monitoring

Review pain or dependence-treatment response, sedation and bowel habit; with patches review at each change.

Counselling the patient

With a patch, avoid heat over it and follow the change schedule; dispose of used patches safely.
Do not combine it with alcohol or other sedatives.
In dependence treatment, take it exactly as directed regarding timing.

Evidence & guidelines

Used for chronic pain (patches) and as a first-line option in opioid-dependence treatment (NICE TA114), with a relative ceiling on respiratory depression.

Reference: SmPC BuTrans / Suboxone / Sublocade; NICE TA114 / TA354; UK Drug Misuse and Dependence Guidelines 2017 ('Orange Book'); MOTHER trial NEJM 2010; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways