Last reviewed 2026-04-20 · How we verify

Subutex (Buprenorphine Hydrochloride)

Subutex (generic name: Buprenorphine Hydrochloride) is a partial opioid agonist Small molecule drug developed by Indivior. It is currently FDA-approved (first approved 1981) for Acute postoperative pain, Chronic Pain with Opioid Tolerance, Chronic pain.

Buprenorphine is a partial agonist at mu-opioid receptors and antagonist at kappa-opioid receptors.

Buprenorphine sublingual tablets are indicated for treatment of opioid dependence and are preferred for induction as part of a complete treatment plan including counseling and psychosocial support. The drug is a partial mu-opioid agonist with a long half-life of 31-35 hours and high protein binding of 96%. Major risks include respiratory depression and death when combined with CNS depressants, particularly benzodiazepines, requiring careful monitoring and consideration of naloxone co-prescription. The medication's partial agonist mechanism and favorable pharmacokinetic profile support its use as a safer alternative to full opioid agonists in opioid use disorder treatment.

At a glance

Mechanism of action

Buprenorphine sublingual tablets contain buprenorphine, which functions as a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. The partial agonist activity at the mu-opioid receptor provides therapeutic effects for opioid dependence treatment while the antagonist activity at kappa-opioid receptors contributes to its overall pharmacological profile. This dual mechanism of action distinguishes buprenorphine from full mu-opioid agonists and contributes to its safety profile in opioid use disorder treatment.

Approved indications

• Acute postoperative pain
• Chronic Pain with Opioid Tolerance
• Chronic pain
• Opioid dependence
• Prevention of opioid abuse
• Severe pain

Common side effects

• Emergency department visit
• Nausea
• Constipation
• Vomiting
• Anxiety
• Headache
• Injection site pain
• Insomnia
• Nasopharyngitis
• Restlessness
• Hyperhidrosis
• Injection site erythema

Drug interactions

• Benzodiazepines or other CNS depressants (including alcohol, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids)
• CYP3A4 inhibitors

Key clinical trials

• Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
• Chicago Data-driven Opioid Use Disorder Screening, Engagement, Treatment and Planning System (NA)
• Integrated Outpatient Treatment of Opioid Use Disorder and Severe Injection Related Infections (PHASE2)
• Outcome Inference in the Sensory Preconditioning Task in Opioid-Use Disorder
• Open Trial of Technology-Enhanced Behavioral Intervention for Buprenorphine Retention in Pregnant and Postpartum People (EARLY_PHASE1)
• Extended-release Buprenorphine as a Novel Low-dose Induction Strategy (PHASE2)
• Pain Management Teams Using Whole Health to Optimize Function and Safety in Veterans: The TEAMWORK Trial (NA)
• Evaluation of Tirzepatide as an Adjunct to Buprenorphine for the Treatment of Opioid Use Disorder (PHASE2)

Patents

Primary sources

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Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Subutex CI brief — competitive landscape report
• Subutex updates RSS · CI watch RSS
• Indivior portfolio CI

Frequently asked questions about Subutex

Related

• Drug class: All partial opioid agonist drugs
• Target: All drugs targeting mu-opioid receptor, kappa-opioid receptor
• Manufacturer: Indivior — full pipeline
• Therapeutic area: All drugs in Pain
• Indication: Drugs for Acute postoperative pain
• Indication: Drugs for Chronic Pain with Opioid Tolerance
• Indication: Drugs for Chronic pain
• Compare: Subutex vs similar drugs
• Pricing: Subutex cost, discount & access