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Am J Perinatol 1999; 16(4): 157-160
DOI: 10.1055/s-2007-993850
ORIGINAL ARTICLE

© 1999 by Thieme Medical Publishers, Inc.

Pregnancy Outcome Following First-Trimester Exposure To Zopiclone: A Prospective Controlled Cohort Study

Orna Diav-Citrin, Bunmi Okotore, Kristen Lucarelli, Gideon Koren
  • Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Research Institute, the Hospital for Sick Children and the University of Toronto, Ontario, Canada
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Publikationsdatum:
04. März 2008 (online)

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ABSTRACT

Background & Aim: Zopiclone, a cyclopyrrolone derivative, is a short-acting hypnotic. To date, no published data exist regarding human pregnancy experience with zopiclone. The purpose of this study was to compare pregnancy outcome following first-trimester exposure to zopiclone with that of a matched control group of women, who were counseled for nonteratogenic exposure. Methods: The Motherisk Program, the Toronto Teratogen Information Service, prospectively collected and followed up 40 women exposed to zopiclone during pregnancy. Pregnancy outcome was compared with that of a matched control group of women, who were counseled for nonteratogenic exposure. Results: There was no increase in the rate of major malformations (0 of 31 [0%] for zopiclone vs. 1 of 37 [2.7%] for nonteratogenic controls; p = 1). Conclusions: Our study, which is the first cohort on zopiclone use during embryogenesis, albeit small, suggests that zopiclone does not appear to be a major human teratogen. Larger studies are needed to establish its safety during pregnancy.

Keywords

Zopiclone - insomnia - human pregnancy