Z-Drug Use in the First Trimester of Pregnancy and Risk of Congenital Malformations

Is exposure to nonbenzodiazepine sedative hypnotics (Z-drugs) in the first trimester of pregnancy associated with increased risk of congenital malformations?In this cohort study of 4.3 million pregnancies in the United States, there was no difference in risk of congenital malformations overall among infants exposed to Z-drugs in the first trimester compared with unexposed infants. The risk of some rare, individual malformations was higher among infants exposed to Z-drugs, but estimates were imprecise.First-trimester Z-drug exposure was not associated with a higher risk of congenital malformations, which provides reassurance on the use of Z-drugs for sleep dysregulation during pregnancy.

Corresponding Author: Kelly Fung, MS, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (kfung@bwh.harvard.edu).

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