Zolpimist and Pregnancy

Is Zolpimist Safe During Pregnancy?

Zolpimist^™ (zolpidem oral spray) is a prescription sleep medication. Based on the results of animal studies, this medication may not be safe for use in pregnancy (although the full risks are not currently known).

 

Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.

 

When given to pregnant rats at high doses, zolpidem (the active ingredient in Zolpimist) caused problems in bone formation of the fetal skull. When given to pregnant rabbits at high doses in early pregnancy, zolpidem increased the risk of miscarriages and problems in bone formation. When given later in pregnancy (and during lactation), zolpidem decreased the pup survival and growth.

 

None of the animal studies suggested that Zolpimist caused birth defects.

 

It is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to pregnant women if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.