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Modafinil Use in Pregnancy Tied to Congenital Malformations

Key clinical point: Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Major finding: Modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

Study details: A retrospective registry-based study of 828,644 unexposed pregnancies, 32,466 methylphenidate-exposed (active comparator) pregnancies, and 49 modafinil-exposed pregnancies.

Disclosures: The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.


Damkier P, Broe A. JAMA. 2020;323(4):374-6.