Buprenorphine + naloxone

Partial Opioid Agonist·Addiction Medicine

Maintenance treatment for Opioid Use Disorder

S8PBSOUD / S8SuboxoneTGA

Max Dose

32 mg/day

Half-life

24–42 h

Precip. W/D

RISK

Resp. Depression

CEILING

Rapid Summary

Overview

Buprenorphine/naloxone soluble film for opioid-dependence treatment within medical, social and psychological care. Buprenorphine provides partial mu-agonist activity; naloxone is included to reduce injection misuse.

Maximum Dose

Max 32 mg/day (based on the Buprenorphine component).

Clinical Focus

Start only when withdrawal is established enough to reduce precipitated-withdrawal risk. Severe hepatic impairment is contraindicated; moderate hepatic impairment requires caution because naloxone exposure rises disproportionately.

Bottom Line

Useful OAT option with lower overdose risk than full agonists, but induction timing, hepatic function, CNS depressants, dental effects, and acute-pain planning need active management.

Formulation & Access

Brand Names

Suboxone

Oral Routes

Soluble films for sublingual or buccal administration. Supplied strengths include 2/0.5 mg and 8/2 mg in Australia; films are not designed to be split or swallowed whole.

Prescribing & PBS

S8. PBS search confirms Suboxone Film listings under S100 HSD Community Access for 2/0.5 mg and 8/2 mg films; confirm current jurisdictional OAT authority and PBS restriction details before prescribing.

Indications & Use

Primary

PBSTGA

Maintenance treatment for Opioid Use Disorder.

Clinical Place

Safer than Methadone due to lower overdose risk and less QTc prolongation.

Quick reference

Class & Role

Partial Opioid Agonist — Sublingual partial mu-opioid agonist combined with an antagonist (Naloxone).

Route / Formulation

Sublingual/buccal films (2/0.5 mg and 8/2 mg supplied in Australia). Do not swallow whole, cut, chew, or split films; allow complete dissolution.

Usual Dose & Max

Induct only when objective opioid withdrawal is present. Initial dosing is individualised; adjust by clinical response. Maintenance commonly 8-24 mg/day; max 32 mg/day buprenorphine.

Key Indication Doses

Opioid Use Disorder (Induction): SL 2-4 mg to start, once the patient is in OBJECTIVE moderate withdrawal (COWS score > 12). Titrate up over days. Maintenance: SL 8-24 mg OD (placed strictly under the tongue, let dissolve).

Best Uses

Buprenorphine + naloxone is the standard opioid substitution therapy for opioid dependence with built-in misuse deterrent, but initiation requires the patient to be in mild withdrawal to avoid precipitated withdrawal.

Avoid / Cautions

Contraindicated in severe respiratory insufficiency, severe hepatic impairment, and hypersensitivity. Moderate hepatic impairment may be inappropriate and needs cautious specialist review. Use caution in severe renal impairment, pregnancy, lactation, and with CNS depressants.

Key Risks

Neurological: Precipitated withdrawal if given while full agonists are still on the receptors. HIGH — Headache, insomnia, sweating. Gastrointestinal: Constipation, nausea. Dental: Chronic sublingual use of acidic films causes severe dental decay/cavities.

Key Interactions

CNS depressants including benzodiazepines, alcohol, gabapentinoids and other opioids increase sedation, respiratory depression, coma and death risk. Full opioid agonist analgesia may be blunted but can still cause toxicity; manage acute pain with specialist input.

Monitoring

Monitor induction response, sedation/respiratory status, precipitated withdrawal, LFTs before and during treatment, hepatic status, renal impairment, dental health, and interacting CNS depressants.

Clinical Pearl

Patients often fear the Naloxone in Suboxone. Reassure them: when dissolved under the tongue, the Naloxone is 100% destroyed by first-pass metabolism. It is only there to punish them if they try to melt it down and inject it into a vein.

Access

Suboxone

Brand: Suboxone
Formulation: Soluble films for sublingual or buccal administration

Buprenorphine + naloxone

Partial Opioid Agonist·Addiction Medicine

Maintenance treatment for Opioid Use Disorder

S8PBSOUD / S8SuboxoneTGA

Max Dose

32 mg/day

Half-life

24–42 h

Precip. W/D

RISK

Resp. Depression

CEILING

Rapid Summary

Overview

Maximum Dose

Max 32 mg/day (based on the Buprenorphine component).

Clinical Focus

Bottom Line

Useful OAT option with lower overdose risk than full agonists, but induction timing, hepatic function, CNS depressants, dental effects, and acute-pain planning need active management.

Formulation & Access

Brand Names

Suboxone

Oral Routes

Soluble films for sublingual or buccal administration. Supplied strengths include 2/0.5 mg and 8/2 mg in Australia; films are not designed to be split or swallowed whole.

Prescribing & PBS

Indications & Use

Primary

PBSTGA

Maintenance treatment for Opioid Use Disorder.

Clinical Place

Safer than Methadone due to lower overdose risk and less QTc prolongation.

Quick reference

Class & Role

Partial Opioid Agonist — Sublingual partial mu-opioid agonist combined with an antagonist (Naloxone).

Route / Formulation

Sublingual/buccal films (2/0.5 mg and 8/2 mg supplied in Australia). Do not swallow whole, cut, chew, or split films; allow complete dissolution.

Usual Dose & Max

Induct only when objective opioid withdrawal is present. Initial dosing is individualised; adjust by clinical response. Maintenance commonly 8-24 mg/day; max 32 mg/day buprenorphine.

Key Indication Doses

Best Uses

Avoid / Cautions

Key Risks

Key Interactions

Monitoring

Monitor induction response, sedation/respiratory status, precipitated withdrawal, LFTs before and during treatment, hepatic status, renal impairment, dental health, and interacting CNS depressants.

Clinical Pearl

Access

Suboxone

Brand: Suboxone
Formulation: Soluble films for sublingual or buccal administration