Provigil and Pregnancy
It is currently not known whether it is safe for pregnant women to take Provigil. Pregnancy problems may occur if an unborn child is exposed to the medication. In clinical studies, the drug increased the risk of miscarriages and birth defects when it was given to pregnant rabbits and rats. Thus, notify your healthcare provider if you are taking Provigil and pregnancy occurs.
Provigil® (modafinil) is a prescription medicine used to promote wakefulness in people with certain sleep disorders. Based on information from animal studies, Provigil may not be safe for use during pregnancy.
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.
In studies, giving Provigil to pregnant rabbits and rats increased the risk of miscarriages and 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 her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
If you are pregnant or are thinking of becoming pregnant while taking Provigil, let your healthcare provider know. He or she will consider both the benefits and risks of taking the drug during pregnancy before making a recommendation in your particular situation.