# Safety of Benzodiazepines and Non-Benzodiazepine Sedative Hypnotics in Pregnancy

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2022 · $678,853

## Abstract

Anxiety disorders comprise a spectrum of conditions, including panic disorder, generalized anxiety disorder,
obsessive-compulsive disorder, posttraumatic stress disorder, social anxiety disorder, and phobias. Their
lifetime prevalence among women has been reported to be as high as 30%, so these disorders frequently
complicate pregnancy. Insomnia is also very common during pregnancy, with a prevalence of nearly 40%.
Pharmacological treatment with benzodiazepines or non-benzodiazepine sedative hypnotics is frequently
indicated for severe anxiety and insomnia; approximately 4% of pregnant women uses one of these classes of
medication during their pregnancy. Polytherapy among women using these medications is common, with 30-
40% being co-prescribed at least two additional psychotropic medications. Benzodiazepines and non-
benzodiazepine sedative hypnotics cross the human placenta and may therefore have the potential to alter
normal intrauterine development of fetal growth, anatomic structures, physical functioning, and postnatal
development.
The American College of Obstetricians and Gynecologists recommends that decisions regarding mental health
treatment during pregnancy be made jointly between a woman and her mental and obstetrical health providers
prior to pregnancy. Unfortunately, rigorous and comprehensive safety data to inform the risk-benefit trade-off
are sparse, evidence is conflicting, and numerous safety concerns have been raised. The objective of the
proposed studies is to address this critical information gap by generating high-quality evidence on the safety of
benzodiazepines and non-benzodiazepine sedative hypnotics during pregnancy considering a broad range of
clinically relevant adverse pregnancy outcomes, including major congenital malformations, spontaneous
abortion, preterm birth, low birth weight, small for gestational age, hypoglycemia, respiratory problems, NICU
admission, and neurodevelopmental disorders.
The use of large, population-based cohorts of publicly and privately insured pregnant women (N ≈ 4.5 million)
will enable quantification of effects with great precision, as well as exploration of the effects for specific drugs,
doses, gestational timing of exposure, and polytherapy. As is the case for all studies evaluating drug safety in
pregnancy given that they are observational in nature by necessity, the most important challenges relate to the
potential for confounding, as well as misclassification of exposures and outcomes as documented in existing
healthcare data. The project will benefit from the multidisciplinary team’s deep experience and established
track record overcoming these challenges in perinatal psychiatry research using highly innovative design and
advanced computational approaches. The findings will have a direct and large public health impact by enabling
treatment to be tailored for the large number of women that struggle with perinatal anxiety and sleep disorders.

## Key facts

- **NIH application ID:** 10519176
- **Project number:** 1R01HD107772-01A1
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** Brian Thomas Bateman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $678,853
- **Award type:** 1
- **Project period:** 2022-08-01 → 2027-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10519176

## Citation

> US National Institutes of Health, RePORTER application 10519176, Safety of Benzodiazepines and Non-Benzodiazepine Sedative Hypnotics in Pregnancy (1R01HD107772-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10519176. Licensed CC0.

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