What is the safe usage of Suboxone (buprenorphine/naloxone) in pregnancy?

From the Guidelines

Suboxone (buprenorphine/naloxone) can be safely used in pregnancy under medical supervision, with buprenorphine alone or in combination with naloxone, as the risks of neonatal abstinence syndrome are less severe compared to methadone or untreated addiction. The decision to use Suboxone during pregnancy should be made on a case-by-case basis, considering the individual patient's needs and medical history. According to a recent study 1, buprenorphine has been shown to be safe and effective in pregnant women with opioid use disorder, with fewer maternal and neonatal adverse events compared to methadone.

Key Considerations

• The typical dosing range for buprenorphine is 4-24 mg daily, adjusted to control withdrawal symptoms and cravings 1.
• Treatment should continue throughout pregnancy and postpartum, with dose adjustments as needed due to pregnancy-related metabolic changes.
• Regular prenatal care is essential, including monitoring for potential complications such as neonatal abstinence syndrome (NAS).
• NAS from buprenorphine exposure typically presents with milder symptoms, shorter hospital stays, and less medication needed compared to methadone 1.

Benefits of Medication-Assisted Treatment

• Preventing withdrawal, which can cause fetal distress or miscarriage
• Reducing illicit drug use
• Improving prenatal care adherence
• Stabilizing maternal opioid levels
• Protecting both mother and baby from the dangers of untreated opioid use disorder and the cycle of intoxication and withdrawal 1.

Important Notes

• Buprenorphine monotherapy (e.g., Subutex) and combination therapy with buprenorphine and naloxone (e.g., Suboxone) have similar safety profiles during pregnancy 1.
• The FDA recommends careful medication management for women concurrently using benzodiazepines or other central nervous system depressants while taking buprenorphine 1.

From the FDA Drug Label

Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome Available data with buprenorphine hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage Reproductive and developmental studies in rats and rabbits identified adverse events at approximately 2 times the maximum recommended human dose (MRHD) of 1.8 mg/day of buprenorphine hydrochloride. The safety of buprenorphine hydrochloride given during labor and delivery has not been established. 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.

The safe usage of Suboxone (buprenorphine/naloxone) in pregnancy is not well established due to insufficient data. However, it is known that:

• Neonatal opioid withdrawal syndrome may occur with extended use during pregnancy.
• Respiratory depression in the newborn is a potential risk if used prior to delivery.
• Monitoring of neonates for signs of respiratory depression and neonatal opioid withdrawal syndrome is recommended.
• The safety during labor and delivery has not been established 2.

From the Research

Safe Usage of Suboxone in Pregnancy

The safe usage of Suboxone (buprenorphine/naloxone) in pregnancy is a topic of interest due to the increasing prevalence of opioid use disorder (OUD) among pregnant women.

• Studies have shown that buprenorphine is a safe and effective option for the treatment of OUD in pregnancy 3, 4.
• Buprenorphine has been associated with more favorable neonatal outcomes, including lower rates of neonatal abstinence syndrome (NAS) and fewer cases of fetal growth restriction, compared to methadone 5, 6, 7.
• The American College of Obstetricians and Gynecologists (ACOG) recommends that women with OUD be treated with medication-assisted treatment (MAT), either methadone or buprenorphine, as part of a comprehensive treatment plan 3, 4.

Dosage and Administration

• The optimal dosage of buprenorphine for pregnant women with OUD is not well established, but studies suggest that low to moderate doses (≤16 mg/day) may be associated with more favorable neonatal outcomes 5.
• Buprenorphine/naloxone is typically administered sublingually, and the dosage may need to be adjusted during pregnancy to ensure adequate treatment of OUD symptoms 4.

Breastfeeding and Postpartum Care

• Breastfeeding is recommended for women with OUD who are being treated with buprenorphine, as it has been shown to be safe and beneficial for the infant 3, 4.
• Postpartum care for women with OUD should include comprehensive treatment, including MAT, counseling, and social support, to reduce the risk of relapse and improve maternal and infant outcomes 3, 4.

Comparison with Methadone

• Studies have compared the safety and efficacy of buprenorphine and methadone for the treatment of OUD in pregnancy, with some studies suggesting that buprenorphine may be associated with more favorable neonatal outcomes 6, 7.
• However, methadone is still a commonly used treatment for OUD in pregnancy, and the choice of medication should be individualized based on the woman's specific needs and medical history 3, 4.