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While zolpidem crosses the placenta, little is known about its safety in pregnancy. We assessed associations between self\u2010reported zolpidem use 1\u2009month before pregnancy through to the end of the third month (\u201cearly pregnancy\u201d) and specific birth defects using data from two multi\u2010site case\u2013control studies: National Birth Defects Prevention Study and Slone Epidemiology Center Birth Defects Study. Analysis included 39,711 birth defect cases and 23,035 controls without a birth defect. For defects with \u2265\u20095 exposed cases, we used logistic regression with Firth's penalised likelihood to estimate adjusted odds ratios and 95% confidence intervals, considering age at delivery, race\/ethnicity, education, body mass index, parity, early\u2010pregnancy antipsychotic, anxiolytic, antidepressant use, early\u2010pregnancy opioid use, early\u2010pregnancy smoking, and study as potential covariates. For defects with three\u2013four exposed cases, we estimated crude odds ratios and 95% confidence intervals. Additionally, we explored differences in odds ratios using propensity score\u2010adjustment and conducted a probabilistic bias analysis of exposure misclassification. Overall, 84 (0.2%) cases and 46 (0.2%) controls reported early\u2010pregnancy zolpidem use. Seven defects had sufficient sample size to calculate adjusted odds ratios, which ranged from 0.76 for cleft lip to 2.18 for gastroschisis. Four defects had odds ratios &gt;\u20091.8. All confidence intervals included the null. Zolpidem use was rare. We could not calculate adjusted odds ratios for most defects and estimates are imprecise. Results do not support a large increase in risk, but smaller increases in risk for certain defects cannot be ruled out.<\/jats:p>","DOI":"10.1111\/jsr.13958","type":"journal-article","created":{"date-parts":[[2023,6,3]],"date-time":"2023-06-03T06:29:26Z","timestamp":1685773766000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Maternal exposure to zolpidem and risk of specific birth defects"],"prefix":"10.1111","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8420-5040","authenticated-orcid":false,"given":"Meredith M.","family":"Howley","sequence":"first","affiliation":[{"name":"New York State Department of Health Birth Defects Registry  Albany New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martha M.","family":"Werler","sequence":"additional","affiliation":[{"name":"Department of Epidemiology Boston University School of Public Health  Boston Massachusetts 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