Suboxone (Buprenorphine/Naloxone) Treatment for Opioid Use Disorder
For individuals with opioid use disorder, initiate Suboxone after stabilization on sublingual buprenorphine 8-24 mg daily for at least 7 consecutive days, with target maintenance doses of 16-32 mg daily, combined with behavioral therapies to reduce mortality and improve treatment retention. 1, 2
Patient Selection and Assessment
Ideal candidates for buprenorphine treatment include:
- Patients with prior good response to buprenorphine 3
- Those with access to a buprenorphine prescriber and ability to engage with care 3
- Patients with inadequate response to methadone 3
- Individuals seeking less restrictive treatment compared to methadone programs 4
Key assessment considerations:
- Evaluate risk of relapse, expected withdrawal severity, and comorbid conditions before initiating treatment 2
- Screen for concurrent benzodiazepine or CNS depressant use (methadone may be more appropriate, though buprenorphine should not be withheld if it's the only accessible option with careful medication management) 3
- Assess for QT-prolonging medications, as concomitant use is contraindicated 1, 2
Induction Protocol
Critical requirement: Patients must be in mild opioid withdrawal before first dose to avoid precipitated withdrawal. 3, 2
Abstinence periods required:
- Short-acting opioids: 12-24 hours before induction 3
- Long-acting opioids: 36-48 hours before induction 3
- Verify mild withdrawal symptoms using a validated opioid withdrawal scale before administering first dose 3
Standard induction approach:
- Administer initial buprenorphine dose when patient demonstrates mild withdrawal 3
- Reassess with validated withdrawal scale 30 minutes after initial dose 3
- If tolerated, give another 2-4 mg dose of buprenorphine 3
- Titrate to 8-24 mg daily over first week 1, 2
Alternative micro-dosing approach (for patients unable to abstain):
- Day 1: 0.5 mg once daily 5
- Day 2: 0.5 mg twice daily 5
- Day 3: 1 mg twice daily 5
- Day 4: 2 mg twice daily 5
- Day 5: 3 mg twice daily 5
- Day 6: 4 mg twice daily 5
- Day 7: 12 mg once daily, discontinue all full opioid agonists 5
- This approach allows induction while continuing other opioids and avoids precipitated withdrawal 5
Maintenance Dosing
Target daily dose: 16 mg is sufficient to suppress illicit opioid use in most patients, though effective doses range from 4-24 mg daily. 3
Higher dosing considerations:
- Doses up to 32 mg/day are safe and effective 6
- Increasing from 24 mg to 32 mg significantly reduces opioid use (68.5% to 59.5%), frequency of use per week (1.58 to 1.15 episodes), and physiologic triggers for use (38.2% to 7.0%) 6
- Retention rates are significantly higher with 32 mg dosing (78.7%) compared to 24 mg (50.0%) 6
- For patients with continued opioid use on 24 mg, increase to 32 mg rather than accepting suboptimal outcomes 6
Pregnancy-specific dosing:
- Higher and more frequent doses (2-4 times daily) may be required during pregnancy, increasing with gestational age 3
- Daily dose of 16 mg suppresses illicit opioid use in most pregnant women, with range of 4-24 mg daily 3
Formulation Selection
Suboxone (buprenorphine/naloxone combination) vs. Subutex (buprenorphine alone):
- Historically, buprenorphine monotherapy was recommended for pregnancy due to theoretical naloxone risks 3
- Current evidence does not support this theoretical concern—women already on Suboxone who become pregnant should continue combination therapy 3
- The naloxone component reduces abuse potential when taken as prescribed sublingually, as naloxone exerts no clinically significant effect 7
- If administered parenterally in opioid-dependent patients, naloxone causes withdrawal, deterring misuse 7
Long-acting injectable buprenorphine (Sublocade):
- Indicated for patients stabilized on transmucosal buprenorphine 8-24 mg daily for minimum 7 days 1, 2
- First two monthly doses: 300 mg subcutaneous injection 1, 2
- Maintenance doses: 100 mg monthly 1, 2
- Benefits include decreased diversion risk and improved adherence 4
- Never attempt removal after administration—risks include surgical complications, infection, and tissue damage 1, 2
Integration with Comprehensive Care
Behavioral therapy is mandatory:
- All medication-assisted treatment must be combined with behavioral therapies 1
- This integrated approach improves outcomes for substance use disorders 1
Provider requirements:
- Prescribers must have appropriate training and certification 1
- Physicians can obtain waiver from SAMHSA to prescribe buprenorphine in office-based settings 1
- Identify community treatment resources and ensure sufficient treatment capacity 1
Special Populations
Pregnant women:
- Buprenorphine demonstrates safety and tolerability in pregnancy 3
- Compared to methadone, buprenorphine-exposed newborns require less medication for neonatal opioid withdrawal syndrome, have shorter treatment duration and hospital stays, and better birth outcomes (weight, length, gestational age) 3
- No differences in maternal relapse rates, cesarean delivery rates, or serious adverse events between buprenorphine and methadone 3
- Methadone shows higher study completion rates 3
- Continue buprenorphine throughout postpartum year—establish feasibility during pregnancy 3
Patients requiring surgery:
- Buprenorphine's high mu-opioid receptor binding affinity may interfere with perioperative pain management 2
- Plan ahead with surgical and anesthesia teams 2
Critical Drug Interactions and Contraindications
Absolute contraindication:
Significant interactions resulting in:
- QT-interval prolongation 1, 2
- Serotonin syndrome 1, 2
- Paralytic ileus 1, 2
- Reduced analgesic effect 1, 2
- Precipitation of withdrawal symptoms 1, 2
Monitoring and Follow-up
Initial monitoring:
- Monitor closely after first dose for precipitated withdrawal, especially in patients recently using full opioid agonists 2
- For long-acting injectable formulations, monitor after first injection 1
Ongoing assessment:
- Track opioid use through patient report and urine drug screens 6
- Assess frequency of use and triggers 6
- Monitor retention in treatment 6
Common Pitfalls to Avoid
- Do not initiate buprenorphine before patient is in withdrawal—this precipitates acute withdrawal 3, 2
- Do not underdose—16 mg is the evidence-based target, with many patients benefiting from 24-32 mg 3, 6
- Do not withhold buprenorphine from pregnant women on combination therapy—continue Suboxone rather than switching to monotherapy 3
- Do not accept continued opioid use on 24 mg without increasing to 32 mg—higher dosing significantly improves outcomes 6
- Do not prescribe buprenorphine without arranging behavioral therapy—combination treatment is the standard of care 1