Version June 2024
| Considerations | Buprenorphine | Methadone |
| Patient selection | May be preferable for patients who are new to treatment because it is easier to transfer from buprenorphine to methadone (it can be very difficult to transfer from methadone to buprenorphine), who do not like or want methadone, or who have requested this medication. | May be preferable for patients who do not like or want buprenorphine treatment or who have requested this medication. |
| Care | Includes a prenatal health care professional, parenting classes, and SUD treatment. | Includes a prenatal health care professional, parenting classes, and SUD treatment. |
| Dispensing | May be prescribed in an office setting with weekly or biweekly prescribing/dispensing or provided in an opioid treatment program. | Requires daily visits to a federally certified opioid treatment program; take-home medication is provided for patients meeting specific requirements. |
| Treatment retention | Some studies show treatment dropout is higher than that for methadone. | Some studies show treatment retention is higher than that for buprenorphine. |
| Risk of medication interaction | Few known interactions with other medications; risk of interaction is greatest with CNS depressants and CYP3A4 inhibitors (eg, clarithromycin, itraconazole, ketoconazole, atazanavir). If these medications must be used, the clinic should monitor the patient daily for increased effect of buprenorphine; health care professionals should be aware that the development of sign and symptom varies and depends on a variety of factors. Other agonist/antagonist medications (eg, butorphanol, dezocine, nalbuphine, pentazocine) and full antagonists will result in precipitated withdrawal. | Medications that use CYP450 enzymes are commonly involved in a methadone-medication interaction. Methadone is metabolized primarily by CYP3A4 and CYP2B6. There is evidence that other CYP450 enzymes are also involved including CYP2D6. Known interactions with other medications in pregnant women are detailed elsewhere.[1] If these medications must be used, the clinic should monitor the patient daily for increased or decreased effect of methadone; health care professionals should be aware that the development of sign and symptom varies and depends on a variety of factors. Other agonist/antagonist medications (eg, butorphanol, dezocine, nalbuphine, pentazocine) and full antagonists will result in precipitated withdrawal. |
| Starting dose | 2 to 4 mg sublingually. | 20 to 30 mg orally. |
| Target dose | Daily, 16 mg sublingually or product equivalent to 16 mg sublingually, is the most common dose. The optimal dose will be determined by regular assessment of the individual and her response to treatment. | Daily, 80 to 120 mg orally. The optimal dose will be determined by regular assessment of the individual and her response to treatment. |
| Interval at which dose may be increased | Daily, but dose changes should not be made without patient assessment. | Three days is a common interval in a clinical practice, but dose changes should not be made without patient assessment. |
| Risk of overdose and death | Generally lower risk compared with full opioid agonists; overdose is possible when combined with other CNS depressants. Continued buprenorphine treatment reduces mortality after release from incarceration.[2] Buprenorphine treatment reduces the risk of death in people dependent on opioids[3] and drug-related mortality in the first four weeks of treatment, a high-risk period.[4] | Generally greater risk of overdose compared with mixed agonist/antagonist opioids; overdose is possible when combined with other CNS depressants. Continued methadone treatment reduces mortality after release from incarceration.[2] Methadone significantly reduces the risk of drug-related mortality compared with no treatment.[5] Methadone treatment reduces the risk of death in people dependent on opioids[3] and drug-related mortality in the first four weeks of treatment, a high-risk period.[4] |
| Risk of sedation | Sedation is possible but typically milder than that with full mu opioid agonists. | Sedation is possible and may be greater than that with partial agonist opioids.[6] |
| Ability to fill a prescription at a local pharmacy | Is possible depending on pharmacy availability. | Can be filled in a certified pharmacy to treat pain, but methadone for the treatment of OUD cannot generally be obtained from a pharmacy in the United States. It must be administered or dispensed for treatment of OUD at a certified opioid treatment program. |
| Treatment in a health care professional's office | Can be prescribed by any provider who is licensed under state law and possesses schedule III authority on their valid Drug Enforcement Administration registration. | May be possible under federal regulation if specific program criteria are fulfilled and relevant state and federal permission is sought. |
| Risk of NAS | Approximately 50% of exposed neonates are treated for NAS; NAS may be milder with buprenorphine compared with full mu opioid agonists such as most opioid analgesics and methadone. | Approximately 50% of exposed neonates are treated for NAS. |
| Time to NAS onset | The AAP recommends monitoring prenatally opioid-exposed neonates for a minimum of four to seven days after delivery.[7] | The AAP recommends monitoring prenatally opioid-exposed neonates for a minimum of four to seven days after delivery.[7] |
| Duration of NAS | Most studies show shorter NAS duration compared with methadone. | Most studies show longer NAS duration compared with buprenorphine. |
| Breastfeeding considerations | Generally safe if the mother is stable and the ABM clinical protocol #21 breastfeeding with SUD guidelines[8] are met. | Generally safe if the mother is stable and the ABM clinical protocol #21 breastfeeding with SUD guidelines[8] are met. |
| Neurodevelopmental outcomes of exposed children | Available research suggests there is not a linear cause and effect relationship between prenatal buprenorphine exposure and developmental problems when compared with other opioids; the research base is limited. | Available research suggests there is not a linear cause and effect relationship between prenatal methadone exposure and developmental problems when compared with other opioids; the research base is limited. |
Reproduced from: Substance Abuse and Mental Health Services Administration. Clinical Guidance for Treating Pregnant and Parenting Women With Opioid Use Disorder and Their Infants. HHS Publication No. (SMA) 18-5054. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2018.
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