Table 3. FDA-approved medications for OUD, with typical dosing paradigms for each of the approved formulations.
Treatment | Dose range | Considerations |
Methadone (PO) | 80–150 mg/day (typical range) |
Maintenance dosing is determined during the early weeks of treatment following upward titration. Individual genetic and drug history differences may lead to requirement of higher doses than the typical range. FDA approved in 1972. |
Buprenorphine- naloxone (SL or BUC) |
8–24 mg/day buprenorphine (1–6 mg/day naltrexone) (typical range) |
4:1 ratio (w/w) of buprenorphine- naloxone. Because of partial agonist nature of buprenorphine, no further treatment effect to be gained by doses greater than 24 mg/day. FDA approved in 2002. |
Buprenorphine extended-release formulation (SQ) |
80–300 mg/monthly injection |
Two formulations available. FDA approved in 2016 and 2017. |
Naltrexone tablets (PO)/extended- release formulation (IM) |
50 or 100 mg/day orally; 380 mg/ monthly IM injection |
Requires a patient to be opioid free for 7–10 days before administration. FDA approved in 1984 (tablets, no longer marketed); 2010 (extended release). |