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Buprenorphine + Naloxone

A film dissolved under the tongue to treat opioid dependence.

Clinical information

Common uses

  • opioid dependence, with counselling and support

Common side effects

  • mouth numbness, soreness or redness
  • headache
  • feeling sick and vomiting
  • constipation
  • sweating and trouble sleeping

Cautions

  • life-threatening slowed breathing, especially with sedatives or alcohol
  • can be misused — risk of dependence
  • dangerous to children — store safely out of reach
  • liver problems can occur — liver tests recommended

Interactions

  • benzodiazepines, alcohol and other sedatives — risk of fatal breathing problems
  • CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) — effects increase
  • CYP3A4 inducers (e.g. rifampicin, carbamazepine) — effects decrease
  • antidepressants and other serotonergic drugs — serotonin syndrome risk
  • MAOI antidepressants — not recommended within 14 days
  • muscle relaxants — breathing may slow further

Pregnancy: dose may need adjusting; newborn withdrawal can occur

Reference information, not medical advice — always follow your doctor or pharmacist. Source: DailyMed, dailymed.nlm.nih.gov, buprenorphine and naloxone sublingual film label, setid 58d2c995-c0cf-a007-e063-6394a90a3f77 (accessed 2026-08-16)

Approved brands & formulations3

Brand nameDosage formStrengthImporterCategory
Addnok N Tablets 2/0.5Tablet2mg + 0.5mgcontrolled
Buprenorphine + NaloxoneTablet2mg + 0.5mgMFDA designated importers with Pre Authorization approval before importcontrolled
Buprenorphine + NaloxoneTablet8mg + 2mgMFDA designated importers with Pre Authorization approval before importcontrolled
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