Suboxone (Buprenorphine/Naloxone) for Opioid Use Disorder
Buprenorphine/naloxone (Suboxone) is the preferred first-line medication for treating opioid use disorder and must be combined with behavioral therapies to achieve optimal outcomes. 1, 2
Medication Selection
- Prescribe buprenorphine/naloxone (Suboxone) rather than buprenorphine alone (Subutex) for most patients because the naloxone component prevents misuse by crushing and injecting the medication. 1, 3
- The only exceptions where buprenorphine alone may be appropriate are pregnancy, documented naloxone allergy, or severe chronic pain requiring divided dosing. 1
- Target a maintenance dose of 16 mg daily for most patients, with a therapeutic range of 8-16 mg daily. 1, 2
Initiation Protocol: Critical Safety Steps
Buprenorphine must only be started when patients are in active opioid withdrawal to prevent precipitated withdrawal. 1, 2, 3 This is the most common pitfall in treatment initiation.
Timing Requirements Before First Dose:
- Short-acting opioids (heroin, oxycodone): Wait >12 hours since last use 1
- Extended-release formulations: Wait >24 hours since last use 1
- Methadone maintenance: Wait >72 hours since last use 1
Confirm Withdrawal Using COWS:
- Use the Clinical Opiate Withdrawal Scale (COWS) to objectively assess withdrawal severity before administering the first dose. 1
Dosing Schedule:
Essential Treatment Components Beyond Medication
Medication alone has poor long-term outcomes—buprenorphine must be combined with counseling and behavioral therapies. 4, 1, 2 This "whole-patient" approach is non-negotiable for success.
Additional required elements:
- Provide overdose prevention education and take-home naloxone kit at treatment initiation, as patients remain at overdose risk if they relapse. 2
- Offer hepatitis C and HIV screening as part of comprehensive care. 1, 2
Managing Concomitant Benzodiazepine Use
Do not categorically deny buprenorphine treatment to patients taking benzodiazepines, as prohibiting treatment poses greater mortality risk from untreated opioid use disorder. 3
Risk Mitigation Strategy:
- Educate patients about the increased risk of respiratory depression, overdose, and death when combining buprenorphine with benzodiazepines or other CNS depressants. 4, 3
- Gradually taper benzodiazepines when possible, using evidence-based psychotherapies (CBT) and non-benzodiazepine medications for anxiety. 4
- If tapering both medications is necessary, taper opioids first as it is safer and more practical; benzodiazepine withdrawal can cause seizures, delirium tremens, and rarely death. 4
- Do not impose arbitrary dose caps on buprenorphine as a strategy to address benzodiazepine use—there is no evidence supporting this approach. 3
- If a patient is sedated at dosing time, delay or omit the buprenorphine dose. 3
Monitoring Requirements:
- Check the prescription drug monitoring program (PDMP) for concurrent controlled medications. 4
- Coordinate care with mental health professionals managing the patient's anxiety or other conditions. 4
- Consider involving pharmacists and addiction specialists as part of the management team. 4
Monitoring and Follow-Up Schedule
- Reassess within 1-4 weeks of starting buprenorphine to evaluate benefits and harms. 2
- Regular urine drug testing to assess for illicit opioid use and medication adherence. 1, 2
- Reassess at least every 3 months using DSM-5 criteria to monitor for sustained improvement in pain/function and signs of opioid use disorder. 4
- Patients at higher risk (depression, history of substance use disorder, history of overdose, taking ≥50 MME/day of other opioids, or taking CNS depressants) require more frequent monitoring than every 3 months. 4
Managing Chronic Pain in Patients on Buprenorphine Maintenance
For patients on buprenorphine maintenance who develop acute or chronic pain:
- First step: Increase buprenorphine dose in divided doses (every 6-8 hours) rather than switching medications. Doses of 4-16 mg divided into 8-hour intervals have shown benefit. 4
- Second step: Consider switching from sublingual buprenorphine/naloxone to transdermal buprenorphine patch, which bypasses hepatic first-pass metabolism and may provide better analgesia. 4
- Third step: Add a long-acting potent opioid (fentanyl, morphine, or hydromorphone) if maximal buprenorphine dose is reached. 4
- Important caveat: Buprenorphine's high binding affinity for μ-opioid receptors may block lower doses of other opioids from working, so higher doses of additional opioids may be required with close monitoring. 4
- Last resort: Transition from buprenorphine to methadone maintenance if pain remains inadequately controlled despite above strategies. 4
Treatment Duration and Discontinuation
Encourage indefinite continuation of buprenorphine treatment, as discontinuation substantially increases overdose risk if patients return to illicit opioid use. 5, 6 Longer treatment duration allows restoration of social connections and is associated with better outcomes. 6
Special Populations
Pregnancy:
- Use buprenorphine without naloxone (Subutex) in pregnant women with opioid use disorder, as medication-assisted therapy improves maternal outcomes. 4
- Advise pregnant women of neonatal opioid withdrawal syndrome (NOWS) risk and ensure appropriate neonatal treatment will be available. 3
Pediatric Safety:
- Store buprenorphine safely out of sight and reach of children, as accidental exposure can cause severe, possibly fatal respiratory depression. 3
Common Pitfalls to Avoid
- Never initiate buprenorphine while patients are still under the influence of full opioid agonists—this causes precipitated withdrawal. 1, 2
- Do not withhold treatment from abstinent patients with cravings—cravings indicate active disease requiring treatment, and delaying increases relapse and overdose risk. 2
- Avoid concomitant use with QT-prolonging agents due to cardiac arrhythmia risk. 1, 2
- Do not prescribe multiple early refills without appropriate follow-up visits, especially early in treatment. 3