{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Howley MM"],"funding":["NCBDD CDC HHS","ACL HHS","EPA","HSRD VA","National Center on Birth Defects and Developmental Disabilities","Intramural CDC HHS"],"pagination":["e13958"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10926928"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["33(1)"],"pubmed_abstract":["Zolpidem is a non-benzodiazepine agent indicated for treatment of insomnia. While zolpidem crosses the placenta, little is known about its safety in pregnancy. We assessed associations between self-reported zolpidem use 1 month before pregnancy through to the end of the third month (\"early pregnancy\") and specific birth defects using data from two multi-site case-control 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 ≥ 5 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-pregnancy antipsychotic, anxiolytic, antidepressant use, early-pregnancy opioid use, early-pregnancy smoking, and study as potential covariates. For defects with three-four exposed cases, we estimated crude odds ratios and 95% confidence intervals. Additionally, we explored differences in odds ratios using propensity score-adjustment and conducted a probabilistic bias analysis of exposure misclassification. Overall, 84 (0.2%) cases and 46 (0.2%) controls reported early-pregnancy 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 > 1.8. 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."],"journal":["Journal of sleep research"],"pubmed_title":["Maternal exposure to zolpidem and risk of specific birth defects."],"pmcid":["PMC10926928"],"funding_grant_id":["U01 DD001304","U01 DD001227","FOA #DD09-001","FOA #DD09‐001","PA #96043","CC999999","CDP 13-003","U01DD001227","PA #02081","U01 DD001037","FOA #DD13‐003","U01 DD001224","EP-D-18-001","U01 DD001300","FOA #DD13-003","U01 DD001032"],"pubmed_authors":["Hansen C","Fisher SC","Van Zutphen AR","National Birth Defects Prevention Study","Werler MM","Papadopoulos EA","Ailes EC","Reefhuis J","Howley MM","Wood ME","Browne ML","Tracy M"],"additional_accession":[]},"is_claimable":false,"name":"Maternal exposure to zolpidem and risk of specific birth defects.","description":"Zolpidem is a non-benzodiazepine agent indicated for treatment of insomnia. While zolpidem crosses the placenta, little is known about its safety in pregnancy. We assessed associations between self-reported zolpidem use 1 month before pregnancy through to the end of the third month (\"early pregnancy\") and specific birth defects using data from two multi-site case-control 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 ≥ 5 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-pregnancy antipsychotic, anxiolytic, antidepressant use, early-pregnancy opioid use, early-pregnancy smoking, and study as potential covariates. For defects with three-four exposed cases, we estimated crude odds ratios and 95% confidence intervals. Additionally, we explored differences in odds ratios using propensity score-adjustment and conducted a probabilistic bias analysis of exposure misclassification. Overall, 84 (0.2%) cases and 46 (0.2%) controls reported early-pregnancy 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 > 1.8. 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.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Feb","modification":"2026-06-27T03:20:19.289Z","creation":"2025-04-05T10:19:07.829Z"},"accession":"S-EPMC10926928","cross_references":{"pubmed":["37269133"],"doi":["10.1111/jsr.13958"]}}