Modafinil is indicated in adults for the treatment of excessive sleepiness associated with narcolepsy, with or without cataplexy.
Based on post-marketing reports from the US Nuvigil and Provigil Pregnancy Registry and other spontaneous sources, use of modafinil during pregnancy is suspected to cause congenital malformations (including congenital heart defects, hypospadias, and orofacial clefts)
As per results from the study regulators stated “Modafinil should not be used during pregnancy.
Alternative treatment options should be used during pregnancy, including behaviour modifying measures, sleep hygiene, and scheduled daytime naps.
Women of childbearing potential must use effective contraception during treatment with, and for 2 months after stopping, modafinil”.
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