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U.S. Department of Health and Human Services

Safety

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Ambien IR and Ambien CR (zolpidem tartrate)tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2010

 

Summary View

 

USE IN SPECIFIC POPULATIONS

Neonatal Complications
  • Studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other CNS depressants.