Even More About Maternal Modafinil During Pregnancy

The U.S. Provigil/Nuvigil voluntary pregnancy registry was established in 2010 to collect data on exposure to modafinil and armodafinil (the R-enantiomer of modafinil) during pregnancy. These FDA-approved, nonnarcotic prescription drugs are used to treat patients with excessive daytime sleepiness (due to narcolepsy, obstructive sleep apnea, or shiftwork sleep disorder) but are increasingly used off label. By 2019, this industry-funded registry had accumulated data on 148 pregnant women with exposure to modafinil, armodafinil, or both drugs. Most exposures (96%) occurred during the first trimester.

Major congenital malformations affected 13% of 116 prospectively enrolled pregnancies and 18% of 26 retrospectively enrolled pregnancies with know…