Ambien CR During Pregnancy

There have been no human studies conducted on the effects of taking Ambien CR during pregnancy. In pregnant animal studies, however, the sleep medicine showed no negative long-term effects on fetuses. There have been cases of newborns having withdrawal symptoms when their mother took Ambien CR late in pregnancy, but these symptoms generally improved after several days.

 

Ambien CR During Pregnancy: An Overview

Ambien CR™ (zolpidem tartrate extended-release tablets) is considered a pregnancy Category B medicine by the U.S. Food and Drug Administration (FDA), which means that Ambien CR has not been studied in pregnant women. However, when studied in pregnant animals, Ambien CR showed no negative long-term effects on unborn babies.
 
There have been cases of newborns having Ambien CR withdrawal symptoms when their mother took Ambien CR late in pregnancy. These symptoms generally improved after several days and usually did not require any treatment. There have also been cases of sedation of the unborn baby when Ambien CR is used during the last weeks of pregnancy.
 

Ambien CR and Pregnancy Category B

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 B is given to medicines that have not been studied in humans but show no harm to the fetus in pregnant animal studies.
 
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category B 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.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;