{"doi":"10.1111/jsr.13958","title":"Maternal exposure to zolpidem and risk of specific birth defects","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","year":2023,"id":360744,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":9,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9573,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2023-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":379338,"name":"Martha M. Werler","orcid":"0000-0003-3392-6814","position":1,"is_corresponding":false},{"id":275141,"name":"Sarah C. Fisher","orcid":"0000-0002-4702-1007","position":2,"is_corresponding":false},{"id":715325,"name":"Melissa Tracy","orcid":"0000-0003-3209-0197","position":3,"is_corresponding":false},{"id":448855,"name":"Alissa R. Van Zutphen","orcid":"0000-0002-3599-8857","position":4,"is_corresponding":false},{"id":968670,"name":"Eleni A. Papadopoulos","orcid":"0000-0003-4355-7557","position":5,"is_corresponding":false},{"id":492953,"name":"Craig Hansen","orcid":null,"position":6,"is_corresponding":false},{"id":385365,"name":"Elizabeth C. Ailes","orcid":"0000-0003-2062-8148","position":7,"is_corresponding":false},{"id":385369,"name":"Jennita Reefhuis","orcid":"0000-0002-4747-4831","position":8,"is_corresponding":false},{"id":824027,"name":"Mollie E. Wood","orcid":"0000-0002-9302-2641","position":9,"is_corresponding":false},{"id":275140,"name":"Marilyn L. Browne","orcid":"0000-0002-1872-2787","position":10,"is_corresponding":false},{"id":924444,"name":"for the National Birth Defects Prevention Study","orcid":null,"position":11,"is_corresponding":false},{"id":644680,"name":"Meredith M. Howley","orcid":"0000-0002-8420-5040","position":0,"is_corresponding":true}],"reference_count":49,"raw_metadata":null,"created_at":"2026-07-19T01:14:06.433417Z","pmid":"37269133","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}