Lunesta and Pregnancy

There are a number of complications and side effects that are associated with the use of Lunesta, and pregnancy problems are a potential risk. Although the sleep medicine has not been studied in pregnant humans, animal studies show possible complications to a developing fetus. Lunesta is classified as a pregnancy Category C medicine, meaning it should only be given to a pregnant woman if the healthcare provider believes the benefits outweigh the possible risks to an unborn child.

 

Lunesta and Pregnancy: An Overview

For women who are pregnant, Lunesta® (eszopiclone) may not be safe. This is based on animal studies that looked at the effects of Lunesta during pregnancy.
 

Lunesta and 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.
 
Lunesta was given a pregnancy Category C rating based on studies in pregnant animals. Very large doses of Lunesta given to pregnant rats have been shown to cause miscarriage, decreased weight of newborn rats, and decreased survival of newborn rats. Because it is generally considered unethical to study most medications in women who are pregnant, Lunesta has not been studied in pregnant women.
 
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 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;