Suboxone Safety in Pregnancy for Opioid Use Disorder
Suboxone (buprenorphine/naloxone) is safe for treating opioid use disorder during pregnancy and can be used when Subutex (buprenorphine monotherapy) is not available. 1, 2
Evidence Supporting Suboxone Use in Pregnancy
The historical preference for buprenorphine monotherapy (Subutex) over combination therapy with naloxone (Suboxone) during pregnancy was based on theoretical concerns about the naloxone component potentially causing fetal withdrawal. However, current evidence does not support this theoretical concern 1:
- Recent data show similar or even more favorable outcomes with buprenorphine/naloxone compared to buprenorphine alone during pregnancy 2
- For women who become pregnant while already on Suboxone, continuation of the combination therapy is recommended by experts 1
Comparative Safety Data
A 2024 population-based cohort study published in JAMA examined 3,369 pregnant individuals exposed to buprenorphine/naloxone and 5,326 exposed to buprenorphine alone, finding 2:
- Lower risk of neonatal abstinence syndrome with Suboxone (37.4% vs 55.8%)
- Modestly lower risk for NICU admission (30.6% vs 34.9%)
- Lower risk for small-for-gestational-age infants (10.0% vs 12.4%)
- No differences in major congenital malformations, low birth weight, preterm birth, respiratory symptoms, or cesarean delivery
- Similar rates of maternal morbidity (2.6% vs 2.9%)
Benefits of Buprenorphine Treatment in Pregnancy
Compared to methadone, buprenorphine treatment (either formulation) offers several advantages 1, 3:
- Less medication required to treat neonatal opioid withdrawal syndrome (NOWS)
- Shorter duration of NOWS treatment and hospital stays
- More favorable outcomes for birthweight, birth length, and gestational age
- Lower risk of preterm birth (14.4% vs 24.9%)
Management Considerations
When using Suboxone in pregnancy:
- Dosing requirements may increase during pregnancy, particularly with advancing gestational age 1
- A daily dosage of 16 mg is sufficient to suppress illicit opioid use in most pregnant women, though dosages can range from 4-24 mg daily 1
- Higher and more frequent doses (2-4 times daily) may be required during pregnancy 1
- Induction requires careful monitoring for withdrawal symptoms using validated scales 1
Important Caveats
- Patients should be informed that while historical practice favored buprenorphine monotherapy, current evidence supports the safety of Suboxone in pregnancy 2
- The FDA label for buprenorphine notes that available data in pregnant women are insufficient to determine a drug-associated risk for major birth defects and miscarriage, but animal studies have shown adverse events at approximately 2 times the maximum recommended human dose 4
- Neonatal opioid withdrawal syndrome may occur and should be monitored for after birth 4
Conclusion
The most recent and highest quality evidence indicates that Suboxone is a safe option for pregnant women with opioid use disorder when Subutex is not available. The theoretical concerns about naloxone causing fetal harm have not been supported by clinical data, and in some measures, outcomes may actually be better with the combination product.