Treating Opioid Use Disorder During Pregnancy: Are Suboxone and Subutex Safe?
Key takeaways:
Suboxone (buprenorphine / naloxone) and Subutex (buprenorphine) are both first-choice medications for treating opioid use disorder (OUD) during pregnancy. When comparing Suboxone versus Subutex, they’re both considered equally safe and effective.
Treating OUD during pregnancy is essential. For the mother, treatment for OUD decreases the risk of overdose, death, and pregnancy complications. For the fetus, treatment decreases the risk of being born early and possibly with birth defects.
Research hasn’t shown that Suboxone or Subutex causes long-term, negative effects for babies born to mothers who took these medications. But in the short term, neonatal opioid withdrawal syndrome is possible.
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Medications are the gold standard for treating opioid use disorder (OUD). One first-choice medication option is Suboxone (buprenorphine / naloxone), which has been used to treat OUD for over two decades.
Treating OUD during pregnancy is important because it can significantly improve health outcomes for you and your baby. Suboxone is a good option in pregnancy, but so is Subutex — which contains buprenorphine without naloxone. When it comes to taking Suboxone versus Subutex during pregnancy, there are some important differences to consider.
Subutex tablets used to be available as a brand-name medication, but it’s no longer available. However, generic buprenorphine tablets still are. Still, we’ll refer to buprenorphine tablets as Subutex throughout this article since this name is well known.
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Can you take Suboxone while pregnant?
Yes. Suboxone is a first-choice medication for treating OUD during pregnancy.
For example, a review of seven studies found Suboxone to be safe and effective. In this review, taking Suboxone during pregnancy didn’t increase a baby’s risk of low birth weight, being born early (preterm delivery), or birth defects.
Taking Suboxone also decreased opioid use by the mother. Reduced opioid use is known to decrease the risk of overdose and death.
Suboxone vs. Subutex in pregnancy: Is one better than the other?
During pregnancy, both Suboxone and Subutex are reasonable options for treating OUD. They both can reduce cravings and opioid withdrawal symptoms. This reduces the risk of overdose and death.
The American Society of Addiction Medicine (ASAM) considers Suboxone or Subutex treatment during pregnancy to be equally safe and effective. In the U.S., ASAM is the go-to organization for treatment recommendations for OUD. But there’s more to this discussion than you might think.
Historically, Subutex was preferred over Suboxone. This is because we had limited research on naloxone use during pregnancy. But as years have passed, we’ve gained more experience with Suboxone treatment during pregnancy. This includes the review discussed previously. One study from this review even compared Suboxone directly to Subutex and found they worked equally well. They were also considered equally safe.
Suboxone is available as a film that dissolves under the tongue (sublingual). Another product that contains the same ingredients as Suboxone (called Zubsolv) is available as a sublingual tablet, as is Subutex.
What are the benefits of taking Suboxone or Subutex during pregnancy?
If you have OUD, treating it during pregnancy leads to better health outcomes.
Treating OUD during pregnancy can decrease your risk of:
Overdose deaths during pregnancy
Death during hospitalization
Needing a C-section
Preeclampsia (a serious condition in pregnancy that involves high blood pressure and organ damage)
Needing a blood transfusion
Treating OUD also improves health outcomes for your baby. It can decrease your baby’s risk of:
Preterm delivery
Experiencing severe opioid withdrawal symptoms
Potential birth defects, including cleft palate, heart defects, and clubfoot (where the foot is turned down and inward)
Stillbirth
Knowing these risks, it’s essential to treat OUD during pregnancy. Suboxone and Subutex are both safe options that increase your chances of quitting opioids compared to not using medication at all. They also stabilize the environment for your baby in the womb by helping you avoid the repetitive cycle of opioid withdrawal.
Suboxone and Subutex increase your chances of quitting opioids compared to not taking medication. They also stabilize your baby's environment in the womb by helping you avoid the repetitive cycle of opioid withdrawal.
What are the risks of taking Suboxone or Subutex during pregnancy?
Common Suboxone and Subutex side effects include nausea and constipation. These are typical opioid side effects. But they may be less intense with Suboxone or Subutex compared to other opioids. You may also experience lower blood pressure, trouble sleeping, and anxiety.
Buprenorphine doesn’t usually cause severe side effects. But if it’s misused, serious risks are possible, including slowed breathing and overdose. Liver damage is rare, but also possible.
To minimize these risks, only take Suboxone or Subutex exactly as prescribed. And don’t use other medications or substances that can slow down breathing, such as benzodiazepines and alcohol.
Good to know: If you or a loved one has OUD, it’s a good idea to carry Narcan (naloxone) on you at all times. This is true even if your OUD is being treated. Narcan is a fast-acting medication that reverses the effects of an opioid overdose. It comes as a nasal spray and injection. You can get a prescription from your prescriber, but it’s also available over the counter.
Are there long-term effects for babies born to mothers taking Suboxone or Subutex?
Research hasn’t shown that Suboxone or Subutex increase the risk of birth defects or long-term developmental problems. The more likely risk is neonatal opioid withdrawal syndrome (NOWS).
The term NOWS is often used interchangeably with NAS, or neonatal abstinence syndrome.
What is NOWS and what are the risks?
NOWS is a condition where a developing fetus exposed to opioids has opioid withdrawal after they’re born. This is because after birth, when they’re not exposed to opioids, their opioid blood levels quickly drop and cause withdrawal.
It may seem confusing that a medication taken to treat OUD could cause opioid withdrawal. But buprenorphine products, such as Suboxone or Subutex, are actually considered opioids – though they’re partial opioids. This means that they don’t produce the full effects of a typical opioid. But by having opioid characteristics, developing NOWS is possible for a fetus exposed to buprenorphine in the womb.
NOWS usually happens after long-term opioid exposure. Withdrawal symptoms in your baby may include irritability, crying, and jitteriness. They may also experience diarrhea, vomiting, and faster breathing.
It’s possible that NOWS can have long-term effects on your baby, including learning and behavioral problems later in life. But these effects are hard to study, so the research isn’t clear. One small study showed that taking Subutex during pregnancy didn’t cause long-term problems to the infant, even if they experienced NOWs.
If you’ve been taking Suboxone or Subutex for OUD during pregnancy, you may be monitored in the hospital for longer than usual. This is to make sure your baby is recovering from NOWS if they have it. NOWS is treatable, and there are several treatment options available.
Good to know: While Suboxone or Subutex can cause NOWS, untreated OUD is even more likely to cause NOWS due to continued opioid use. And untreated OUD during pregnancy has many more risks for your baby than NOWS.
Can you take Suboxone or Subutex while breastfeeding?
Suboxone and Subutex may pass into breast milk in very low amounts. Both ASAM and the Substance Abuse and Mental Health Services Administration (SAMHSA) recommend breastfeeding for most people taking Suboxone or Subutex. Breastfeeding can improve NOWS, minimize the need for medications to treat NOWS, and shorten the time your baby needs to be in the hospital.
Still, it’s a good idea to talk to your prescriber and OB-GYN about breastfeeding if you’re taking Subutex or Suboxone. If they give you the go-ahead, make sure to monitor your baby for signs of increased drowsiness or slowed breathing. These effects are unlikely, but if they do occur, call 911 or seek emergency care.
What other medications are used to treat OUD during pregnancy?
Methadone (Methadose) is another first choice option for treating OUD in pregnancy. But Vivitrol (naltrexone) — another OUD medication option — isn’t recommended during pregnancy, unless you were taking it before becoming pregnant. In this case, it may be reasonable to continue taking it. However, in many instances your prescriber will recommend switching to methadone or a buprenorphine-containing product.
There are several differences between methadone and Suboxone or Subutex. For example, methadone is a full opioid, meaning it’s more likely to cause typical opioid side effects such as nausea and constipation. There’s also some research showing that taking methadone while pregnant is more likely to cause NOWS than taking Suboxone or Subutex.
Additionally, methadone is only prescribed and obtained through a certified opioid treatment program (OTP). Methadone doses are only dispensed at an OTP, which requires daily visits to the OTP clinic initially. On the other hand, Suboxone and Subutex can be prescribed by any prescriber with a Drug Enforcement Administration license.
When it comes to choosing Suboxone, Subutex, or methadone for OUD in pregnancy, they’re all effective options. The best choice for you is often the medication you’re most likely to stick with. Talk with your healthcare team to weigh your options.
The bottom line
Suboxone (buprenorphine / naloxone) and Subutex (buprenorphine) are first-choice medications for treating opioid use disorder (OUD) in pregnancy. When comparing Suboxone versus Subutex, they’re considered equally safe and effective.
Current research hasn’t found negative long-term effects in babies born to mothers who took Suboxone or Subutex. And although a more short-term side effect called neonatal opioid withdrawal syndrome (NOWS) is possible in infants whose mothers took Suboxone or Subutex, the risks associated with NOWS are considered much less severe than the risks of continued opioid use.
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References
American College of Obstetricians and Gynecologists. (2017). Opioid use and opioid use disorder in pregnancy.
American Society of Addiction Medicine. (2020). The ASAM National Practice Guideline for the treatment of opioid use disorder: 2020 focused update.
Anbalagan, S., et al. (2023). Neonatal abstinence syndrome. StatPearls.
Blazes, C. K., et al. (2020). Reconsidering the usefulness of adding naloxone to buprenorphine. Frontiers in Psychiatry.
Dr. Reddys Laboratories Inc. (2024). Buprenorphine and naloxone- buprenorphine and naloxone film, soluble [package insert].
