More on Maternal Modafinil During Pregnancy

As the number of young women treated with the stimulant modafinil (Provigil) has grown, a registry established by the manufacturer has indicated possible teratogenic effects; moreover, a Danish study reported a 12% risk for major malformations among 49 modafinil-exposed infants. Given these concerns, researchers conducted the largest retrospective cohort study to date with pooled data from birth registries in Norway and Sweden.

Pregnant women who received modafinil were more likely to have been smokers and overweight or obese. However, among the infants of 133 women with first-trimester exposure to modafinil, prevalence of major malformations was 2.6% — similar to that in unexposed pregnancies.