Silenor and Pregnancy
When pregnant animals were given high amounts of the active ingredient in Silenor (doxepin tablets), it increased the risk of problems, such as low fetal weight, structural abnormalities, and decreased newborn survival. However, it is unclear whether these problems would occur in humans. If you become pregnant while using this medication, your healthcare provider will weigh the benefits and potential risks before making a recommendation.
Can Pregnant Women Take Silenor?Silenor® (doxepin tablets) is a prescription insomnia medication. At this point, it is unclear if Silenor is safe for use during pregnancy.
What Is 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.
Animal studies have not shown any negative effects to a fetus, except when doxepin (the active ingredient in Silenor) was used at very high doses. When high doses of doxepin were given to pregnant laboratory animals, it increased the risk of low fetal weight, structural abnormalities, and decreased newborn survival.
One small study showed that doxepin use during pregnancy in humans might be associated with certain birth defects (including heart defects, cleft palate, and too many fingers or toes), although this has not been confirmed in other studies.
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.