Can a pregnant woman safely use Suboxone (buprenorphine/naloxone) for opioid dependence?

Can a Pregnant Female Take Suboxone?

Yes, pregnant women can safely take Suboxone (buprenorphine/naloxone) for opioid use disorder, and women already on Suboxone who become pregnant should continue it throughout pregnancy rather than switching to buprenorphine monotherapy. 1

Current Guideline Recommendations

The American College of Obstetricians and Gynecologists (ACOG), Society for Maternal-Fetal Medicine (SMFM), and American Society of Addiction Medicine (ASAM) explicitly state that available data do not support the theoretical concern about naloxone precipitating fetal withdrawal, and recommend continuation of buprenorphine/naloxone combination for women already taking Suboxone who become pregnant. 2, 1

• For women initiating treatment during pregnancy, either buprenorphine monotherapy or buprenorphine/naloxone combination are both appropriate options. 1
• Buprenorphine/naloxone should not be withheld from pregnant women based solely on the naloxone component, as the theoretical risk is not supported by clinical evidence. 1

Safety Profile and Outcomes

Maternal Safety

• The most recent high-quality evidence from a 2024 population-based cohort study of 8,695 pregnant women found similar or more favorable outcomes with buprenorphine/naloxone compared to buprenorphine alone, with no increased risk of maternal morbidity (2.6% vs 2.9%). 3
• A 2023 Finnish study confirmed that buprenorphine-naloxone and buprenorphine monotherapy showed similar outcomes and did not significantly differ in terms of maternal health during pregnancy or delivery. 4

Fetal and Neonatal Safety

• Neither methadone nor buprenorphine (with or without naloxone) has been associated with an increase in birth defects. 2
• The 2024 study found no differences in major congenital malformations, low birth weight, preterm birth, or respiratory symptoms between buprenorphine/naloxone and buprenorphine alone. 3
• Buprenorphine/naloxone was actually associated with lower rates of neonatal abstinence syndrome (37.4% vs 55.8%) and modestly lower rates of NICU admission (30.6% vs 34.9%) compared to buprenorphine alone. 3

Advantages Over Methadone

• Infants exposed to buprenorphine require less medication for neonatal opioid withdrawal syndrome, have shorter treatment duration, and shorter hospital stays compared to methadone. 1
• In the landmark MOTHER trial, buprenorphine-exposed neonates required significantly less morphine (mean 1.1 mg vs 10.4 mg), had shorter hospital stays (10.0 vs 17.5 days), and shorter treatment duration for withdrawal (4.1 vs 9.9 days) compared to methadone. 5

Practical Prescribing Guidelines

Dosing Considerations

• Typical maintenance dosing is 16 mg daily, though doses can range from 4-24 mg daily depending on individual needs. 2, 1
• Higher or split doses (2-4 times daily) may be required as pregnancy progresses due to increased metabolism and physiological changes. 2, 1
• Monitor for withdrawal symptoms at each visit and adjust dosing accordingly. 5

Treatment Initiation

• For women not currently on treatment, buprenorphine induction requires the patient to be experiencing opioid withdrawal before administration. 2
• Women should abstain from short-acting opioids for 12-24 hours and long-acting opioids for 36-48 hours before induction. 2
• Verify at least mild withdrawal symptoms using a validated opioid withdrawal scale before administering the first dose. 2

Critical Pitfalls to Avoid

• Never abruptly discontinue methadone or buprenorphine during pregnancy, as withdrawal poses significant risks to both mother and fetus. 6
• Do not attempt medication-assisted withdrawal or detoxification during pregnancy—medication-assisted treatment with opioid agonists is the only recommended approach. 1, 6
• Do not switch women from buprenorphine/naloxone to buprenorphine monotherapy solely because of pregnancy, as this is not supported by current evidence. 2, 1
• Avoid opioid agonist/antagonists like nalbuphine or butorphanol, as they can precipitate withdrawal. 6

Expected Neonatal Outcomes

• Neonatal opioid withdrawal syndrome (NOWS) occurs in approximately 40-60% of neonates born to women receiving opioid agonist therapy, though there is no correlation between NOWS and medication dosage. 2
• NOWS typically becomes apparent within 2-5 days after birth and requires monitoring and potential pharmacological treatment. 2, 5
• Breastfeeding should be encouraged as it decreases NOWS severity. 2
• Longitudinal studies demonstrate minimal to no long-term neurodevelopmental impact when comparing opioid agonist-exposed versus non-exposed children from similar socioeconomic groups. 2

Labor and Postpartum Management

• Women on buprenorphine maintenance therapy should continue their prescribed medication throughout labor and delivery. 6, 5
• Neuraxial analgesia (epidural) should be encouraged for labor pain management. 6
• Additional analgesia with full opioid agonists (fentanyl or hydromorphone) may be required for acute pain, as buprenorphine's partial agonist properties may reduce effectiveness of other opioids. 6, 5
• Continue maintenance therapy throughout the postpartum period to prevent relapse. 6