Edluar and Pregnancy
When the active ingredient of Edluar (zolpidem sublingual tablet) was given to pregnant animals, it caused a number of problems, including miscarriages, delayed bone formation, and delayed growth. However, it is not known if the same problems may occur in humans. If you are taking Edluar and pregnancy occurs, talk to your healthcare provider about the potential risks.
Is Edluar Safe During Pregnancy?
Edluar® (zolpidem sublingual tablet) is a prescription sleep medication. This medicine may not be safe for use in pregnancy, although the full risks are currently unknown.
Edluar and Pregnancy Category C
The U.S. Food and Drug Administration (FDA) uses a 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 that 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.
Animal studies have not suggested that zolpidem (the active ingredient in Edluar) causes birth defects. However, when given to pregnant rats at high doses, zolpidem caused delayed bone formation of the fetal skull. When given to pregnant rabbits at high doses in early pregnancy, it increased the risk of miscarriages and delayed bone formation. In later pregnancy and during lactation, zolpidem decreased pup survival and growth.
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 a healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Chronic use of sedative-hypnotic medications like Edluar near the end of pregnancy may cause withdrawal symptoms in the newborn.