Sonata and Pregnancy

While there have been no human studies conducted on Sonata and pregnancy, animal studies show that the sleep medicine may potentially cause harm to a developing fetus. Sonata is a pregnancy Category C medicine, meaning it can be prescribed if a healthcare provider believes that the benefits to the pregnant woman outweigh the possible risks to the unborn child.

 

Sonata and Pregnancy: An Overview

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

Sonata 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.
 
Sonata was given a pregnancy Category C rating based on studies in pregnant animals. Very large doses of Sonata given to pregnant rats have been shown to cause miscarriages and decreased survival of newborn rats. Also, the baby rats showed decreased growth and development. Because it is generally considered unethical to study most medications in women who are pregnant, Sonata has not been studied in pregnant women.
 
It is also 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.
 
(Sonata and Pregnancy Continued: Page 2)
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;