Is Suboxone Safe in Pregnancy? What Research Shows

Suboxone, the combination of buprenorphine and naloxone, is considered safe to use during pregnancy based on current evidence. Multiple studies comparing it to both buprenorphine alone and methadone have found no adverse effects on fetal development, and outcomes for mothers and infants are similar whether the combination product or buprenorphine alone is used. If you’re already on Suboxone and become pregnant, staying on your medication is far safer than stopping it, which can trigger relapse and put both you and your baby at serious risk.

Why Suboxone Was Once Avoided in Pregnancy

Suboxone contains two active ingredients: buprenorphine, which treats opioid cravings and withdrawal, and naloxone, which blocks opioid effects and is included to discourage misuse by injection. The concern during pregnancy was always about the naloxone component. If someone injects the combination product rather than taking it under the tongue as directed, naloxone can trigger severe withdrawal, and withdrawal during pregnancy is dangerous for the fetus.

Because of this theoretical risk, the buprenorphine-only version (Subutex) was traditionally recommended for pregnant patients. But here’s the key detail: naloxone is not absorbed into the bloodstream in meaningful amounts when the medication is taken under the tongue as prescribed. It passes through the digestive system without becoming active. This means that for patients using their medication correctly, the naloxone component doesn’t actually reach the fetus in significant quantities. The American College of Obstetricians and Gynecologists now acknowledges that recent studies show no adverse effects from the combination product, with outcomes similar to buprenorphine alone.

What the Research Shows for Newborns

Babies exposed to any opioid medication during pregnancy, including buprenorphine-based treatments, can experience neonatal abstinence syndrome (NAS) after birth. This is a temporary withdrawal period where the newborn adjusts to no longer receiving the medication through the placenta. Symptoms can include irritability, difficulty feeding, tremors, and sleep problems.

Not every exposed baby develops NAS severe enough to need treatment. Across seven studies examining Suboxone-exposed pregnancies, the percentage of newborns who needed medication for withdrawal symptoms ranged widely, from 0% in one study to 64% in another. In most studies, the rate fell between 19% and 40%. When treatment was needed, it typically lasted 7 to 11 days, and hospital stays averaged 6 to 10 days. These numbers compare favorably to methadone, the other main medication used for opioid use disorder in pregnancy. In studies directly comparing the two, Suboxone-exposed infants consistently had lower rates of NAS requiring treatment, shorter treatment courses, and shorter hospital stays.

The landmark MOTHER trial, published in the New England Journal of Medicine, found that buprenorphine-exposed infants needed less medication to treat withdrawal, spent less time in the hospital, and showed significantly fewer withdrawal signs than methadone-exposed infants. Infants in the buprenorphine group had 30% lower odds of needing pharmacologic treatment for withdrawal compared to the methadone group (47% versus 57%).

Long-Term Effects on Child Development

A population-based study tracking children born to mothers with opioid use disorder found that buprenorphine exposure during pregnancy carried minimal long-term neurodevelopmental impact. Among children exposed to buprenorphine early in pregnancy, 17% were later diagnosed with a neurodevelopmental condition, compared to 36% in children exposed to methadone during the same period. Children exposed to methadone were roughly 2.3 to 2.8 times more likely to have a neurodevelopmental diagnosis than those exposed to buprenorphine, depending on the timing of exposure. The researchers concluded that buprenorphine is a strong treatment option during pregnancy specifically because of these more favorable developmental outcomes.

Your Dose May Need Adjusting

Pregnancy changes how your body processes buprenorphine. Blood volume increases, liver metabolism speeds up, and the net result is that the same dose produces lower drug levels in your bloodstream than it would outside of pregnancy. Research measuring plasma concentrations in pregnant women found that dose-adjusted levels of buprenorphine drop significantly compared to the non-pregnant state, particularly by the third trimester.

This means you may start feeling withdrawal symptoms creeping in before your next scheduled dose, especially later in pregnancy. If that happens, the solution isn’t always simply taking a higher dose. Splitting your total daily dose into three or four smaller doses taken at regular intervals can keep drug levels more stable throughout the day. For example, women on a twice-daily regimen often see their blood levels dip below therapeutic thresholds within 8 hours of a dose. Switching to three or four times daily can prevent those dips without necessarily increasing the total amount of medication. This is something to discuss with your prescriber if you notice your medication wearing off sooner than usual.

Pain Management During Labor

One practical concern many women on Suboxone have is how labor pain will be managed. Buprenorphine partially blocks opioid receptors, which means standard opioid pain medications may be less effective during labor and delivery. An epidural or spinal block is typically the most reliable option for pain relief, since these work through a completely different mechanism. If you’re delivering at a hospital, let your care team know about your Suboxone use early so they can plan accordingly. You should continue taking your Suboxone through labor and after delivery to prevent withdrawal and protect your recovery.

Breastfeeding on Suboxone

Breastfeeding while taking Suboxone is generally supported. Studies measuring drug levels in breast milk found that only very small amounts of buprenorphine pass through. In women taking doses between 12 mg and 20 mg daily, buprenorphine concentrations in milk were low, averaging between about 2.4 and 8.4 micrograms per liter. When researchers tested the infants’ blood at two weeks of age, buprenorphine was either undetectable or below measurable thresholds in all samples. The tiny amounts that do transfer through breast milk may actually help ease the baby’s transition by providing a very gradual tapering effect, potentially reducing withdrawal severity.

Why Stopping Suboxone Is Riskier Than Continuing

The most important thing to understand is the comparison that actually matters: Suboxone versus untreated opioid use disorder. Stopping medication during pregnancy dramatically increases the risk of relapse, and returning to illicit opioid use carries dangers that far outweigh the manageable risks of continued treatment. Illicit opioids expose the fetus to unpredictable doses, contaminants like fentanyl, and cycles of intoxication and withdrawal that are harmful to fetal development. Overdose is a leading cause of maternal death during and after pregnancy.

Medication-assisted treatment with buprenorphine products stabilizes both mother and baby. It allows consistent prenatal care, reduces the risk of preterm birth, and leads to better birth weights compared to untreated opioid use disorder. If you’re on Suboxone and find out you’re pregnant, continuing your medication and connecting with prenatal care is the safest path forward for both of you.