What is the recommended treatment and dosage of Suboxone (buprenorphine/naloxone) for a patient with opioid use disorder?

Suboxone (Buprenorphine/Naloxone) for Opioid Use Disorder

For patients with opioid use disorder, initiate buprenorphine/naloxone at 4 mg/1 mg sublingually and titrate to a target maintenance dose of 16-24 mg/4-6 mg daily, with evidence supporting doses up to 32 mg/8 mg for improved outcomes in patients with ongoing opioid use. 1, 2

Standard Induction Protocol

Traditional Induction Approach

• Wait for objective withdrawal symptoms (Clinical Opioid Withdrawal Scale [COWS] ≥8-12) before administering the first dose to avoid precipitated withdrawal, as buprenorphine's partial agonist properties can displace full opioids from receptors 3, 1
• Start with 4 mg/1 mg buprenorphine/naloxone sublingually on day 1 1
• Observe for 1-2 hours and administer additional 4 mg if withdrawal persists 1
• Day 2: Administer 8-16 mg/2-4 mg based on response 1
• Titrate to maintenance dose of 16-24 mg/4-6 mg daily by day 3-7 1

Micro-Dosing Alternative (For Patients Unable to Achieve Abstinence)

For patients using high-potency illicit opioids (fentanyl) or unable to tolerate withdrawal, micro-dosing allows induction while continuing other opioids:

• Day 1: 0.5 mg once daily 4
• Day 2: 0.5 mg twice daily 4
• Day 3: 1 mg twice daily 4
• Day 4: 2 mg twice daily 4
• Day 5: 3 mg twice daily 4
• Day 6: 4 mg twice daily 4
• Day 7: 12 mg once daily and discontinue all other opioids 4
• This approach prevents precipitated withdrawal in 100% of patients in case series 4

Maintenance Dosing

Target Dose Range

• Most patients stabilize on 16-24 mg/4-6 mg daily 1
• The buprenorphine/naloxone combination uses a 4:1 ratio (e.g., 16 mg/4 mg, 24 mg/6 mg) 1
• Higher doses (32 mg/8 mg) demonstrate superior outcomes: 78.7% retention versus 50% at 24 mg, with reduced opioid use (59.5% vs 68.5%), decreased frequency of use (1.15 vs 1.58 times/week), and elimination of physiologic triggers for use (7% vs 38.2%) 2

Dose Optimization

• If patients report inadequate control of cravings or continue opioid use on standard doses, increase to 32 mg/8 mg daily 2
• Doses above 24 mg are safe and effective, despite FDA labeling suggesting 24 mg as maximum 2
• For chronic pain management in patients on buprenorphine maintenance, divide doses into 8-hour intervals (e.g., 4-16 mg total daily dose split three times daily) 5

Managing Inadequate Response

Stepwise Approach for Breakthrough Pain or Cravings

1. First step: Increase buprenorphine dose in divided doses up to 32 mg daily 5, 2
2. Second step: If maximal buprenorphine dose fails, add a long-acting full opioid agonist (fentanyl, morphine, or hydromorphone) 5
3. Critical caveat: Due to buprenorphine's high receptor binding affinity, higher doses of additional opioids may be required to achieve effect 5
4. Alternative: Transition from buprenorphine/naloxone to buprenorphine transdermal patch alone 5
5. Last resort: If all strategies fail, transition to methadone maintenance 5

Transition to Long-Acting Injectable (Sublocade)

• Stabilize patients on sublingual buprenorphine first to ensure tolerability and establish appropriate dosing needs before transitioning to monthly injectable formulations 3
• This stabilization period minimizes precipitated withdrawal risk and confirms the patient can tolerate buprenorphine 3
• Individualize transition timing based on current sublingual dose, relapse risk, and treatment history 3

Critical Safety Considerations

Overdose Prevention

• Prescribe naloxone rescue kits to all patients receiving buprenorphine, particularly those also taking benzodiazepines, gabapentinoids, or other sedating agents 5
• Educate patients and caregivers on naloxone administration, including its short half-life requiring continued monitoring 5
• Intranasal (2 mg) or intramuscular naloxone formulations are available 5

Managing Naloxone-Precipitated Withdrawal

• If excessive naloxone causes precipitated withdrawal in opioid-dependent patients, buprenorphine 4 mg/1 mg sublingual can rapidly reverse symptoms (COWS reduction from 10 to 3-4 within 30-60 minutes) 6
• Use cautiously: Risk exists for buprenorphine to worsen or sustain precipitated withdrawal in some patients 6

Special Populations and Situations

Patients Failing Opioid Taper

• For patients on high-dose prescription opioids with poor pain control, poor functioning, and poor taper response without opioid use disorder, consider trial of buprenorphine/naloxone as it may reduce urges for dose escalation and is demonstrably safer than high-dose mu agonists 5
• Alternative: Very slow opioid taper over months to years for patients intolerant to buprenorphine 5

Patients with Opioid Use Disorder Diagnosis

• Treatment with medication-assisted therapy is essential 5
• Clinicians must have DEA Drug Addiction Treatment Act waiver to prescribe buprenorphine/naloxone for OUD, or refer to addiction specialist 5
• OUD diagnosis can be difficult in chronic pain patients; consultation with addiction specialist is helpful 5

Common Pitfalls

• Never initiate buprenorphine in patients with full opioid agonists still active in their system without using micro-dosing protocol, as this precipitates severe withdrawal 3, 1
• Do not underdose: Evidence shows 32 mg provides better outcomes than 24 mg, yet many clinicians stop at FDA-suggested maximum of 24 mg 2
• Avoid abrupt discontinuation: If withdrawal from buprenorphine is needed, use gradual dose reduction rather than rapid taper or abrupt cessation 1
• The buprenorphine/naloxone combination (not buprenorphine alone) should be used for OUD treatment due to abuse-deterrent properties 5, 1