Is Suboxone Safe in Pregnancy?

Suboxone is a brand name for a medication containing a combination of buprenorphine and naloxone, which is used to treat Opioid Use Disorder (OUD). Buprenorphine is a partial opioid agonist that helps manage withdrawal symptoms and cravings, while naloxone is added to deter misuse. For a person who is pregnant and has OUD, medical consensus holds that treatment with a medication like buprenorphine is the recommended standard of care. Managing OUD throughout pregnancy is a necessary step toward improving outcomes for both the parent and the developing fetus.

The Necessity of Medication-Assisted Treatment During Pregnancy

Untreated Opioid Use Disorder poses far greater risks to a pregnant person and the fetus than exposure to the treatment medication itself. Without Medication-Assisted Treatment (MAT), the pregnant person faces an increased chance of relapse, which carries an elevated risk of overdose and death, particularly after a period of abstinence. The fluctuating levels of opioids associated with active use can cause repeated cycles of withdrawal and intoxication for the fetus, leading to significant fetal distress.

Abrupt cessation of opioids, or forced detoxification, is not recommended during pregnancy. This practice dramatically increases the risk of relapse and can trigger preterm labor or fetal death. Untreated OUD is also strongly linked to poor prenatal care attendance, infectious disease transmission, and adverse outcomes like poor fetal growth, stillbirth, and preterm delivery. Major medical organizations advocate for MAT as the foundation of care for OUD in pregnant individuals. By stabilizing the parent’s health and reducing illicit opioid use, MAT allows for consistent prenatal care.

Buprenorphine vs. Methadone: Clinical Treatment Standards

The two primary medications used in MAT for OUD during pregnancy are buprenorphine and methadone. Both medications are considered effective and safe, falling under the category of opioid agonist pharmacotherapy, which reduces cravings and withdrawal. Clinical preference often leans toward buprenorphine due to several advantages in management and neonatal outcomes.

Buprenorphine is associated with less severe symptoms of Neonatal Opioid Withdrawal Syndrome (NOWS) in newborns compared to methadone. Infants exposed to buprenorphine generally require less pharmacological treatment for withdrawal and have shorter hospital stays. While buprenorphine monotherapy was historically the preferred form during pregnancy, recent large-scale studies suggest the combination product, buprenorphine/naloxone (Suboxone), is an acceptable alternative.

The naloxone component of Suboxone is minimally absorbed when the medication is taken as directed, meaning its effect on the fetus is negligible. This evidence supports the use of either formulation, offering flexibility in treatment, though the goal remains to achieve stability on the lowest effective dose.

Understanding Neonatal Opioid Withdrawal Syndrome

Neonatal Opioid Withdrawal Syndrome (NOWS), sometimes referred to as Neonatal Abstinence Syndrome (NAS), is an expected outcome when any opioid, including MAT medications, is used during pregnancy. NOWS occurs because the fetus becomes physically dependent on the opioid while in the womb and then experiences withdrawal after birth when the drug supply is cut off. This condition is a result of prenatal opioid exposure, not a failure of the medication-assisted treatment.

Symptoms of NOWS typically begin within the first 72 hours after birth, though onset can vary depending on the specific drug. Common signs involve dysfunction of the central nervous system, including tremors, irritability, a high-pitched cry, and sleep disturbances. Gastrointestinal issues like vomiting, diarrhea, and difficulty feeding are also frequent, alongside autonomic symptoms such as sweating and a stuffy nose.

Treatment for NOWS involves a tiered approach, starting with non-pharmacological care based on the “Eat, Sleep, Console” method. This involves supportive measures like skin-to-skin contact, swaddling, and a quiet environment to help the newborn feed well and sleep undisturbed. If symptoms are severe and affect the infant’s ability to thrive, pharmacological treatment, often with small, tapered doses of morphine or methadone, may be necessary. NOWS is a temporary, treatable condition, and affected infants generally recover fully within days or weeks.

Clinical Management and Postpartum Care

Effective management of OUD during pregnancy requires a coordinated care model involving obstetricians, addiction medicine specialists, and pediatric teams. Throughout the pregnancy, medication dosage may need adjustment, particularly during the third trimester, to maintain stability and account for changes in the person’s metabolism and drug distribution. Dosage adjustments are always individualized and based on a thorough clinical assessment.

The postpartum period is a time of increased risk for relapse, making continued MAT necessary for long-term recovery and parental stability. Breastfeeding is strongly encouraged for parents maintained on buprenorphine, as only minimal amounts of the medication pass into the breast milk. Breastfeeding is beneficial because it helps soothe the newborn, reduces the severity of NOWS symptoms, and can decrease the need for pharmacological treatment in the infant. If a parent is stable on their MAT regimen, the benefits of breastfeeding for both parent and child outweigh the minimal exposure risk.