From the Guidelines
Buprenorphine is the safest opioid to use during pregnancy, as it has been shown to have a more favorable safety and tolerability profile compared to other opioids, such as methadone, in pregnant women with opioid use disorder. When opioid use is medically necessary during pregnancy, buprenorphine is the preferred option due to its partial mu-opioid receptor agonist properties, which reduce the risk of neonatal abstinence syndrome and other adverse outcomes 1. The Maternal Opioid Treatment Experimental Research trial, a double-blind, double-dummy, randomized controlled trial, found that newborn infants exposed to buprenorphine during pregnancy required less medication to treat neonatal abstinence syndrome and had a shorter duration of treatment and hospital stays compared to those exposed to methadone 1.
Some key points to consider when using buprenorphine during pregnancy include:
- Ideal candidates for treatment with buprenorphine include those with a history of a good past response to buprenorphine, availability of a buprenorphine prescriber, and an inadequate response to methadone 1.
- Buprenorphine monotherapy is recommended for pregnant women, although combination therapy with buprenorphine and naloxone may also be safe 1.
- Pregnant women requiring opioid use should work closely with their obstetrician and addiction specialist to develop an individualized treatment plan that considers both maternal and fetal safety, with regular monitoring throughout pregnancy.
It is essential to note that while buprenorphine is considered the safest opioid option during pregnancy, all opioids carry risks, and non-opioid alternatives should be considered first 1. However, when opioid use is necessary, buprenorphine is the preferred choice due to its favorable safety profile and effectiveness in managing opioid use disorder in pregnant women 1.
From the FDA Drug Label
The data on use of buprenorphine, the active ingredient in Buprenorphine Sublingual Tablets, in pregnancy, are limited; however, these data do not indicate an increased risk of major malformations specifically due to buprenorphine Limited data from trials, observational studies, case series, and case reports on buprenorphine use in pregnancy do not indicate an increased risk of major malformations specifically due to buprenorphine In a multicenter, double-blind, randomized, controlled trial [Maternal Opioid Treatment: Human Experimental Research (MOTHER)] designed primarily to assess neonatal opioid withdrawal effects, opioid-dependent pregnant women were randomized to buprenorphine (n=86) or methadone (n=89) treatment, with enrollment at an average gestational age of 18. 7 weeks in both groups. Buprenorphine-exposed neonates required less morphine (mean total dose, 1.1 mg vs. 10.4 mg), had shorter hospital stays (10.0 days vs. 17. 5 days), and shorter duration of treatment for NOWS (4.1 days vs. 9. 9 days) compared to the methadone-exposed group.
Safest Opioid in Pregnancy: Based on the available data, buprenorphine appears to be a safer option for use during pregnancy compared to other opioids, as it does not indicate an increased risk of major malformations specifically due to buprenorphine exposure 2. Additionally, buprenorphine-exposed neonates required less morphine and had shorter hospital stays compared to methadone-exposed neonates 2. However, it is essential to note that the data is limited, and the safest approach would be to use the lowest effective dose and closely monitor the patient and the fetus for any potential adverse effects.
- Key Points:
- Buprenorphine does not indicate an increased risk of major malformations specifically due to buprenorphine exposure.
- Buprenorphine-exposed neonates required less morphine and had shorter hospital stays compared to methadone-exposed neonates.
- Use the lowest effective dose and closely monitor the patient and the fetus for any potential adverse effects.
From the Research
Safest Opioid in Pregnancy
The safest opioid to use during pregnancy is a topic of ongoing research and debate. Several studies have compared the safety and efficacy of different opioids, including buprenorphine and methadone, in pregnant women.
- Buprenorphine vs. Methadone: A study published in The New England Journal of Medicine in 2022 found that buprenorphine may be associated with more favorable neonatal and maternal outcomes than methadone 3. Another study published in the same journal in 2010 found that buprenorphine was associated with a lower risk of neonatal abstinence syndrome and shorter hospital stays for neonates compared to methadone 4.
- Fetal Growth and Neonatal Abstinence Syndrome: A retrospective cohort study published in the American Journal of Perinatology in 2021 found that low- to moderate-dose buprenorphine (≤16 mg/day) was associated with the most favorable neonatal outcomes, including larger head circumference and lower odds of neonatal abstinence syndrome requiring treatment 5.
- Opioid Use in Pregnancy: A review article published in Best Practice & Research: Clinical Obstetrics & Gynaecology in 2022 highlighted the complexities of opioid use in pregnancy and the need for universal screening and treatment programs that meet the specific needs of women 6.
- Medication-Assisted Treatment: A study published in the American Journal of Obstetrics and Gynecology in 2019 emphasized the importance of medication-assisted treatment during pregnancy and the need for a new paradigm of care that includes both medication-assisted treatment and medically supervised opioid withdrawal for select women 7.
Overall, the current evidence suggests that buprenorphine may be a safer option than methadone for pregnant women, particularly at low to moderate doses. However, more research is needed to fully understand the risks and benefits of opioid use in pregnancy and to develop effective treatment strategies for women with opioid use disorders.