CLINICAL QUESTION

In pregnant patients with opioid use disorder, is buprenorphinenaloxone as safe and effective as buprenorphine?

EVIDENCE-BASED ANSWER

Buprenorphine-naloxone can be used to treat opioid use disorder in pregnant patients. It has an obstetric safety profile similar to those of alternative treatments for this disorder and is associated with a lower rate of neonatal opioid withdrawal syndrome (NOWS). (Strength of Recommendation: B, consistent meta-analyses not limited to randomized controlled trials [RCTs].)

EVIDENCE SUMMARY

A 2020 systematic review and meta-analysis identified five retrospective cohort trials with 1,875 pregnant patients receiving various therapies, including buprenorphine-naloxone, for opioid use disorder in pregnancy.¹ Alternative treatments included buprenorphine, methadone, and long-acting opioids.

Compared with other treatment groups, the buprenorphinenaloxone groups had similar rates of full-term delivery (three trials; n = 729; odds ratio [OR] = 1.04; 95% CI, 0.64–1.7), vaginal delivery (three trials; n = 405; OR = 0.87; 95% CI, 0.56–1.34), and neonatal intensive care unit admission (three trials; n = 405; OR = 1.04; 95% CI, 0.68–1.60). Newborns of patients in the buprenorphine-naloxone groups had lower rates of NOWS compared with newborns of patients prescribed other opioid agonist medications (four trials; n = 634; OR = 0.52; 95% CI, 0.36–0.75). Researchers noted that three of the studies had a high risk of bias. This review did not directly compare buprenorphine-naloxone with buprenorphine.