Use in Pregnancy: This drug should only be administered to pregnant women or women suspected of being pregnant, if the expected therapeutic benefits are evaluated to exceed the possible risks of treatment. [The safety of zolpidem in pregnant women has not been established. Children born to mothers who took a zolpidem tartrate formulation during late pregnancy may develop withdrawal symptoms such as respiratory depression, convulsions, tremors, irritability, and nursing difficulties. These symptoms have presented as birth asphyxia in some cases.]
Use in Lactation: It is desirable to avoid the administration of this drug to nursing mothers. However, if the administration is indispensable, nursing should be discontinued. [Transfer to breast milk has been reported and may lead to lethargy in newborns.]