Although results of animal studies have shown reproductive toxic effects with use of modafinil and armodafinil, data on exposure during pregnancy in humans are limited.1,2 The US Provigil/Nuvigil Pregnancy Registry, a postmarketing requirement with data annually reported to the US Food and Drug Administration, was established to evaluate pregnancy and fetal outcomes in individuals who could become pregnant and received these drugs during pregnancy. This report provides results from cumulative data as of February 2019.
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Kaplan S, Braverman DL, Frishman I, Bartov N. Pregnancy and Fetal Outcomes Following Exposure to Modafinil and Armodafinil During Pregnancy. JAMA Intern Med. 2021;181(2):275–277. doi:10.1001/jamainternmed.2020.4009
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