Ambien CR During Pregnancy

Ambien CR During Pregnancy: An Overview

Based on studies in animals, Ambien CR™ (zolpidem tartrate extended-release tablets) may not be safe for use during pregnancy. If you are pregnant, check with your healthcare provider before taking Ambien.

 

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 rabbits at high doses in early pregnancy, zolpidem (the active ingredient in Ambien CR) 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. When given to pregnant rats at high doses, zolpidem caused problems in bone formation of the fetal skull. It should be noted that the high doses of zolpidem used in these animal studies caused toxicity (such as poor weight gain) in the mothers. It is probably this toxicity that indirectly caused the problems for the fetuses, not the medication directly.

 

None of the animal studies suggested that Ambien CR 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 a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.