What are the recommended dosages of Suboxone (buprenorphine/naloxone) film for a patient with opioid use disorder?

Suboxone Film Dosing for Opioid Use Disorder

For opioid use disorder, the standard maintenance dose of Suboxone (buprenorphine/naloxone) film is 16 mg daily, but doses up to 24-32 mg daily are safe, effective, and increasingly necessary in the fentanyl era, with higher doses (32 mg) showing superior retention and reduced opioid use. 1, 2

Induction Protocol

Critical Pre-Induction Requirement:

• Patients MUST be in mild-to-moderate opioid withdrawal before the first dose to avoid precipitated withdrawal 1
• Objective withdrawal signs must be documented before initiating treatment 1
• Never initiate in patients NOT in withdrawal—this causes severe precipitated withdrawal due to buprenorphine displacing full agonists from receptors 1

Standard Induction Approach:

• Fixed dosages of at least 7 mg per day are effective; dosages of 16 mg per day are clearly superior to placebo 3
• The medication is generally well tolerated when taken sublingually as prescribed 4, 5

Alternative Micro-Dosing Protocol (for patients unable to achieve withdrawal):

• Day 1: 0.5 mg once daily
• Day 2: 0.5 mg twice daily
• Day 3: 1 mg twice daily
• Day 4: 2 mg twice daily
• Day 5: 3 mg twice daily
• Day 6: 4 mg twice daily
• Day 7: 12 mg once daily, discontinue all full opioid agonists 6

This approach allows induction while continuing other opioids and avoids precipitated withdrawal 6

Maintenance Dosing

Standard Maintenance:

• 16 mg daily is the typical maintenance dose 1, 3
• Doses up to 24-32 mg daily are safe and increasingly necessary, particularly with fentanyl-contaminated opioid supply 1, 2

Evidence for Higher Dosing:

• Within patients increased from 24 mg to 32 mg, opioid use declined from 68.5% to 59.5% (P = 0.02) 2
• Frequency of use per week decreased from 1.58 to 1.15 times (P = 0.0002) 2
• Physiologic triggers for use dropped from 38.2% to 7.0% (P < 0.0001) 2
• Retention rates were significantly higher at 32 mg (78.7%) compared to 24 mg (50.0%, P = 0.02) 2

Chronic Pain Management (Alternative Indication)

When using Suboxone for chronic pain:

• Divide total daily dose into 8-hour intervals (e.g., 16 mg daily given as 6 mg/6 mg/4 mg) 1
• Dosing range: 4-16 mg divided every 8 hours has demonstrated benefit 1
• 86% of patients achieved moderate-to-substantial pain relief with mean dose of 8 mg daily (range 4-16 mg) in divided doses 1

Transition to Long-Acting Formulations

• Minimum 7 consecutive days on transmucosal buprenorphine (8-24 mg daily) is required before considering long-acting formulations like Sublocade 1
• Never give Sublocade to patients not already on sublingual buprenorphine—this precipitates withdrawal 1

Critical Safety Considerations

Drug Interactions:

• Avoid QT-prolonging agents when prescribing buprenorphine 1
• Monitor for serotonin syndrome with concurrent serotonergic medications 1
• Avoid mixed agonist-antagonist opioids (pentazocine, nalbuphine, butorphanol) as they precipitate withdrawal by displacing buprenorphine 1

Respiratory Safety:

• Buprenorphine has a ceiling effect on respiratory depression even at doses up to 70 times normal analgesic doses, making it safer than full agonists 1
• However, no proven ceiling effect exists for analgesia, supporting use of higher doses for pain 1

Common Adverse Effects:

• Anxiety, constipation, dizziness, drowsiness, headache, nausea, and sedation 3
• These are generally well tolerated 4, 3

Follow-Up Management

• Sporadic opioid use is not uncommon in the first few months and should be addressed by increased visit frequency and more intensive behavioral therapies 3
• Follow-up visits should include documentation of relapses, reemergence of cravings or withdrawal, random urine drug testing, pill or wrapper counts, and checks of state prescription drug database records 3

Mechanism of Abuse Deterrence

• When taken sublingually as prescribed, naloxone exerts no clinically significant effect, leaving buprenorphine's opioid agonist effects to predominate 4
• When parenterally administered in opioid-dependent patients, naloxone causes withdrawal effects, reducing abuse potential 4, 5
• Intramuscular injection of buprenorphine/naloxone precipitates withdrawal in opioid-dependent persons, giving it low abuse potential by injection 5