Can Suboxone (buprenorphine/naloxone) be prescribed to pregnant women with opioid use disorder?

Can Suboxone Be Prescribed to Pregnant Women?

Yes, Suboxone (buprenorphine/naloxone combination) can be prescribed to pregnant women with opioid use disorder, and recent evidence demonstrates it is safe and effective for both maternal and neonatal outcomes. 1

Historical Context vs Current Evidence

While buprenorphine monotherapy (Subutex) was historically preferred over the combination product due to theoretical concerns about naloxone precipitating fetal withdrawal, current guidelines from ACOG, SMFM, and ASAM explicitly state that available data do not support this theoretical concern. 1 For women already taking Suboxone who become pregnant, continuation of the buprenorphine/naloxone combination is recommended by experts rather than switching formulations. 1

Safety Profile Supporting Use

Recent high-quality research directly comparing buprenorphine/naloxone to buprenorphine alone in 8,695 pregnancies found:

• Similar or more favorable outcomes with the combination product, including lower rates of neonatal abstinence syndrome (37.4% vs 55.8%), lower NICU admissions (30.6% vs 34.9%), and lower rates of small for gestational age infants (10.0% vs 12.4%) 2
• No differences in major congenital malformations, preterm birth, or maternal morbidity between the two formulations 2
• Naloxone crosses the placenta with concordant maternal-fetal levels, but this has not translated to adverse outcomes in clinical practice 2, 3

Why Buprenorphine-Based Treatment Should Be Offered

Buprenorphine (with or without naloxone) demonstrates clear advantages over methadone:

• Reduced neonatal morbidity: Infants require less medication for neonatal opioid withdrawal syndrome, have shorter treatment duration, and shorter hospital stays 1, 4
• Better neonatal growth parameters: More favorable birthweight, birth length, and gestational age compared to methadone 1
• Greater accessibility: Can be prescribed in office-based settings rather than requiring daily visits to opioid treatment programs 1
• Lower risk of preterm birth (14.4% vs 24.9% with methadone) and low birth weight (8.3% vs 14.9%) 5

Practical Prescribing Considerations

For women already on Suboxone:

• Continue the current formulation throughout pregnancy rather than switching to monotherapy 1
• Do not abruptly discontinue, as withdrawal poses risks to both mother and fetus 4

For initiating treatment in pregnancy:

• Either buprenorphine monotherapy or buprenorphine/naloxone combination are appropriate options 1, 2
• Induction requires the patient to be in mild opioid withdrawal (12-24 hours from short-acting opioids, 36-48 hours from long-acting opioids) 1
• Typical maintenance dosing is 16 mg daily, though range is 4-24 mg daily 1
• Higher or split doses may be needed as pregnancy progresses due to increased metabolism 1

Critical Pitfalls to Avoid

• Do not withhold buprenorphine/naloxone from pregnant women based solely on the naloxone component - the theoretical risk is not supported by clinical evidence 1, 2
• Do not attempt detoxification during pregnancy - medication-assisted treatment with opioid agonists is the only recommended approach 4, 6, 7
• Ensure postpartum continuation plans are established during pregnancy - treatment should continue throughout the postpartum period 1, 4
• Prescribers must have DEA waiver (though recent regulatory changes have modified these requirements) 1

FDA Labeling Acknowledgment

The FDA label for buprenorphine notes that available data are "insufficient to inform a drug-associated risk for major birth defects and miscarriage" but also states that "limited published data on malformations from trials, observational studies, case series, and case reports on buprenorphine use in pregnancy have not shown an increased risk of major malformations." 8 The label warns about neonatal opioid withdrawal syndrome, which occurs with all opioid agonist therapies but is clinically manageable and expected. 8