Sublocade (Buprenorphine) Use During Pregnancy
Sublocade (extended-release buprenorphine) is not contraindicated in pregnancy and may be considered a safe treatment option for pregnant women with opioid use disorder. Based on available evidence, the safety profile appears consistent with other buprenorphine formulations that are considered standard of care for pregnant women with opioid use disorder.
Evidence on Buprenorphine in Pregnancy
- The FDA label for buprenorphine states that "available data with buprenorphine hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage" 1
- However, human data from trials, observational studies, and case reports "have not shown an increased risk of major malformations" with buprenorphine use in pregnancy 1
- The American College of Obstetricians and Gynecologists and other societies recognize medication-assisted treatment (MAT) with either methadone or buprenorphine as the standard of care for pregnant women with opioid use disorder 2
Specific Evidence on Sublocade in Pregnancy
- Recent data from 2025 examining monthly buprenorphine depot injection (Sublocade) during pregnancy found that over 300 pregnancies have been reported through postmarketing surveillance with 68 known outcomes "consistent with the established safety profile of buprenorphine" 3
- Clinical practice case studies of four pregnant patients who received monthly Sublocade reported all four neonates were delivered full-term with normal birthweight, no fetal anomalies, and no medication required for neonatal opioid withdrawal syndrome 3
- These findings support "consideration of implementing BUP-XR (Sublocade) as part of evidence-based practice that prioritizes OUD treatment access, patient stability, and patient choice during the perinatal period" 3
Important Considerations for Pregnant Women on Sublocade
Benefits of Continuing Treatment
- Discontinuing buprenorphine treatment during pregnancy is not recommended due to high risk of relapse and associated maternal and fetal harms 2
- "Because of the risk of acute maternal withdrawal and relapse, which are 2 conditions that can be harmful or fatal to both mother and fetus/neonate, acute detoxification or attempting to wean or stop opioids before delivery is not recommended for most women" 2
Neonatal Considerations
- Neonatal Opioid Withdrawal Syndrome (NOWS) is a known risk with all forms of buprenorphine during pregnancy 1
- NOWS "presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and/or failure to gain weight" 1
- Newborns should be monitored for signs of NOWS, which typically occur in the first days after birth 1
Labor and Delivery Management
- "The safety of buprenorphine given during labor and delivery has not been established" 1
- Close monitoring of neonates for respiratory depression is recommended, with naloxone available for reversal if needed 1
- Women should remain on their daily dose of MAT medication throughout labor to treat the underlying substance use disorder and prevent acute withdrawal 2
Clinical Recommendation
For pregnant women already on Sublocade:
- Continue treatment rather than discontinuing, as the risks of withdrawal and relapse outweigh potential risks of continued treatment
- Ensure close monitoring during pregnancy with regular prenatal care
- Prepare for potential NOWS in the neonate and have appropriate monitoring and treatment protocols in place
For pregnant women considering starting Sublocade:
- While data specifically on Sublocade in pregnancy is emerging and positive, more extensive data exists for sublingual buprenorphine formulations
- Either formulation appears to be a reasonable option based on the most recent evidence 3, 4
The decision to use Sublocade during pregnancy should be made with informed consent regarding the limited but reassuring data available, weighing the clear benefits of treating opioid use disorder against theoretical risks.