Maternal exposure to zolpidem and risk of specific birth defects

Details

• Alternative Title:
  J Sleep Res
• Personal Author:
  Howley, Meredith M. ; Werler, Martha M. ; Fisher, Sarah C. ; Tracy, Melissa ; Van Zutphen, Alissa R. ; Papadopoulos, Eleni A. ; Hansen, Craig ; Ailes, Elizabeth C. ; Reefhuis, Jennita ; Wood, Mollie E. ; Browne, Marilyn L.
• Corporate Authors:
  National Birth Defects Prevention Study
• 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.
• Subjects:
  Case-Control Studies Female Gastroschisis Humans Logistic Models Maternal Exposure Odds Ratio Pregnancy Risk Factors Zolpidem
• Keywords:
  Birth Defects Medications Pregnancy Sleep Aid Zolpidem
• Source:
  J Sleep Res. 33(1):e13958
• Pubmed ID:
  37269133
• Pubmed Central ID:
  PMC10926928
• Document Type:
  Journal Article
• Funding:
  FOA #DD13-003/DD/NCBDD CDC HHSUnited States/ ; CDP 13-003/HX/HSRD VAUnited States/ ; U01 DD001304/DD/NCBDD CDC HHSUnited States/ ; PA #02081/DD/NCBDD CDC HHSUnited States/ ; U01 DD001227/DD/NCBDD CDC HHSUnited States/ ; CC999999/ImCDC/Intramural CDC HHSUnited States/ ; FOA #DD09-001/DD/NCBDD CDC HHSUnited States/ ; U01 DD001032/DD/NCBDD CDC HHSUnited States/ ; U01 DD001037/DD/NCBDD CDC HHSUnited States/ ; PA #96043/DD/NCBDD CDC HHSUnited States/ ; U01 DD001224/DD/NCBDD CDC HHSUnited States/ ; EP-D-18-001/EPA/EPAUnited States/ ; U01 DD001300/DD/NCBDD CDC HHSUnited States/
• Volume:
  33
• Issue:
  1
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:0d267d01a86c939d1198a104e403b4d2dba7cbb4d22ff0d01fd27a67a17c1302cb45a4b187d2128e467fae7b0cb6c266dd8d9cb4b2f2e4f78ff210321d5d9716
• Download URL:
  https://stacks.cdc.gov/view/cdc/151669/cdc_151669_DS1.pdf
• File Type:
  [PDF - 220.98 KB ]