Assessment of Non-Cardiac Congenital Malformations and in Utero Exposure to Modafinil/Armodafinil in the Sentinel Distributed Database

PROVIGIL® (modafinil, approved by the U.S. FDA in 1998) and NUVIGIL® (armodafinil, approved by the U.S. FDA in 2007) are wakefulness promoting agents. Some but not all previous studies have reported an association between in utero exposure to modafinil/armodafinil and increased risk of major congenital malformations. 

This presentation compares the risk of non-cardiac malformations among pregnancies exposed to modafinil/armodafinil in the first trimester to pregnancies exposed to methylphenidate, amphetamines, or unexposed to the drugs of interest. It was presented at the 2024 ISPE Annual Meeting.