Rozerem and Pregnancy

Rozerem is classified as a pregnancy Category C medicine, which means Rozerem and pregnancy are potentially a dangerous combination. Although the sleep medicine has not been studied in pregnant humans, animal studies show possible side effects to a developing fetus. A pregnant woman may still use Rozerem during pregnancy if her healthcare provider believes the benefits outweigh any possible risks to the unborn child.

 

Rozerem and Pregnancy: An Overview

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

Rozerem 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.
 
In animals, very large doses of Rozerem were shown to cause birth defects. However, 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 a healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child.
 

Recommendations for Rozerem and Pregnancy

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of Rozerem during pregnancy before making a recommendation for your particular situation.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;