What is the indication for Suboxone (buprenorphine)?

Indications for Suboxone (Buprenorphine/Naloxone)

Suboxone (buprenorphine/naloxone) is primarily indicated for the treatment of opioid use disorder (OUD) and should be used as part of a complete treatment plan that includes counseling and psychosocial support. 1

Primary Indications

• FDA-approved indication: Treatment of opioid dependence 1
• Preferred medication for:
  • Opioid use disorder treatment in adults 2, 3
  • Adolescents and young adults 16 years and older with severe opioid use disorder 2
  • Management of opioid withdrawal symptoms in emergency department settings 2

Dosing and Administration

Initial Treatment (Induction)

1. Verify patient is in mild-moderate withdrawal (COWS score >8) before first dose to avoid precipitated withdrawal 3
2. Initial dosing:
   • Start with 2-4 mg sublingual buprenorphine/naloxone based on withdrawal severity 3
   • Reassess after 30-60 minutes 2
   • Additional doses may be administered based on continued withdrawal symptoms
   • Target dose: 16 mg daily (range 4-24 mg based on individual response) 3

Maintenance Treatment

• Standard maintenance: 16 mg daily (range 4-24 mg) 3
• Less frequent dosing possible (e.g., thrice weekly) without compromising efficacy 4
• For pregnant women: Use buprenorphine alone (Subutex) instead of combination product 3

Treatment Setting Options

1. Office-based treatment: Available through physicians with special DEA waiver (X-waiver) 2, 5
2. Emergency department initiation:
   • Non-waivered physicians may administer (but not prescribe) buprenorphine for up to 72 hours while arranging referral 2
   • Limited to one day's medication at a time 2
3. Inpatient initiation: May be used to start treatment during hospitalization 6

Clinical Benefits

• Reduces opioid cravings and withdrawal symptoms 7
• Decreases risk of opioid overdose 3
• Reduces emergency department visits and hospitalizations (45% and 23% respectively) 6
• Improves quality of life in patients who remain in treatment 6
• Safer than full opioid agonists due to ceiling effect on respiratory depression 3

Medication Formulation Considerations

• Suboxone: Combination of buprenorphine with naloxone (4:1 ratio) 4
  • Naloxone has no significant effect when taken sublingually as prescribed
  • If injected, naloxone causes withdrawal in opioid-dependent individuals, reducing abuse potential
• Subutex: Buprenorphine alone, primarily used for induction or in pregnant women 1, 3

Important Precautions

• Contraindications:

  • Concurrent use with benzodiazepines (increased risk of respiratory depression) 3
  • Use with QT-prolonging agents (risk of QT-interval prolongation) 3
  • Duplicate therapy (e.g., using Suboxone and Butran patch together) 3

• Monitoring requirements:

  • Frequent visits initially (weekly for first month)
  • Monthly visits once stable
  • Urine drug testing to verify adherence
  • Review of prescription drug monitoring program data 3

Common Clinical Pitfalls to Avoid

1. Precipitated withdrawal: Administering buprenorphine too soon after last opioid use can cause severe withdrawal due to buprenorphine's high receptor affinity 3
2. Inadequate dosing: Underdosing may lead to continued cravings and relapse 3
3. Lack of comprehensive care: Medication alone is less effective than combined with counseling and psychosocial support 1, 3
4. Abrupt discontinuation: Gradual dose reduction is recommended over rapid reduction or abrupt cessation 8
5. Missing concurrent mental health disorders: Screen for depression and other comorbid conditions 3

Suboxone represents an effective, office-based treatment option for opioid use disorder that, when properly administered as part of a comprehensive treatment plan, can significantly reduce morbidity and mortality associated with opioid addiction.