What is the recommended dosing for Suboxone (buprenorphine/naloxone) film in a patient with opioid use disorder?

Suboxone Film Dosing for Opioid Use Disorder

For standard induction, start Suboxone at 2-4 mg on day 1 when the patient is in mild-to-moderate withdrawal, then rapidly titrate to a target maintenance dose of 16-32 mg daily, as doses below 16 mg are often inadequate for treatment retention and reducing illicit opioid use.

Induction Dosing

Standard Induction Protocol

• Begin induction only when the patient demonstrates objective signs of opioid withdrawal to avoid precipitating withdrawal, as the naloxone component will cause severe withdrawal if administered to someone with full agonist opioids still occupying receptors 1.
• Start with 2-4 mg sublingual buprenorphine/naloxone on day 1, observing for 1-2 hours 2.
• If tolerated without precipitated withdrawal, give additional 2-4 mg doses every 2-4 hours as needed on day 1, up to 8 mg total 2.
• On day 2, increase to 8-16 mg once daily or divided into twice-daily dosing 2.

Micro-Dosing Alternative (For Patients Unable to Abstain)

• For patients using high-potency fentanyl or unable to tolerate withdrawal, consider a 7-day micro-dosing protocol 3:
  • 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 other opioids at this point) 3
• This approach allows continued use of other opioids during the first 6 days without precipitating withdrawal 3.

Maintenance Dosing

Target Dose Range

• The optimal maintenance dose is 16-32 mg daily, not the outdated 16 mg limit 4.
• Fixed doses of at least 16 mg daily are clearly superior to placebo and lower doses for treatment retention and reducing illicit opioid use 2.
• Doses up to 32 mg daily demonstrate dose-dependent benefits including reduced withdrawal symptoms, craving, opioid reward, and improved retention in care 4.
• The FDA's current 16 mg target dose recommendation is outdated given the fentanyl epidemic and should not limit prescribing 4.

Dose Titration

• After induction, titrate upward by 2-4 mg every few days based on patient-reported withdrawal symptoms, cravings, and continued illicit use 2.
• Do not maintain patients on inadequate doses below 16 mg simply to comply with outdated guidelines 4.
• Sporadic opioid use in the first few months is common and should prompt dose optimization rather than treatment discontinuation 2.

Special Considerations for Chronic Pain

Buprenorphine for Dual Diagnosis (OUD + Chronic Pain)

• For patients on buprenorphine maintenance who develop chronic pain, increase the dose in divided doses (every 8 hours) as the initial management step 5.
• Dosing ranges of 4-16 mg divided into 8-hour doses have shown benefit for chronic non-cancer pain, though higher total daily doses (up to 32 mg) may be needed 5.
• If maximal buprenorphine dosing is inadequate for pain control, add a long-acting potent opioid such as fentanyl, morphine, or hydromorphone 5.
• Higher doses of the additional opioid may be required due to buprenorphine's high binding affinity blocking mu-opioid receptors 5.

Administration and Monitoring

Proper Administration

• Place film under the tongue until completely dissolved; do not chew or swallow 6.
• The naloxone component has no clinically significant effect when taken sublingually as prescribed 6, 1.

Follow-Up Schedule

• Week 1-4: Visit 1-2 times weekly for dose adjustments, urine drug testing, and assessment of withdrawal/cravings 2.
• After stabilization: Monthly visits are appropriate for stable patients 2.
• Document any relapses, cravings, withdrawal symptoms, and check state prescription drug monitoring programs at each visit 2.

Common Pitfalls to Avoid

• Underdosing is the most common error: Maintaining patients on 8-12 mg daily often leads to treatment failure and dropout 4, 2.
• Premature induction: Starting buprenorphine before adequate withdrawal develops will precipitate severe withdrawal due to the naloxone component 1.
• Ignoring continued use: Sporadic illicit opioid use early in treatment requires dose optimization and increased behavioral support, not treatment termination 2.
• Arbitrary dose limits: The 16 mg "ceiling" is not evidence-based; many patients require 24-32 mg for optimal outcomes 4.