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Am J Perinatol. 1999;16(4):157-60.

Pregnancy outcome following first-trimester exposure to zopiclone: a prospective controlled cohort study.

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  • 1Department of Pediatrics, Research Institute, the Hospital for Sick Children and the University of Toronto, Ontario, Canada.

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.

PMID:
10458526
[PubMed - indexed for MEDLINE]
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