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Research Letter
January 28, 2020

First-Trimester Pregnancy Exposure to Modafinil and Risk of Congenital Malformations

Author Affiliations
  • 1Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Odense, Denmark
JAMA. 2020;323(4):374-376. doi:10.1001/jama.2019.20008

Modafinil is a stimulant drug used in the treatment of excessive daytime sleepiness associated with narcolepsy.1 In Denmark, it is also sometimes used off-label for fatigue in multiple sclerosis. Modafinil has been discouraged during pregnancy because of a lack of safety data. In June 2019, the manufacturer alerted health care professionals that an interim analysis of postmarketing surveillance data detected major malformations among 15% of children exposed to modafinil during pregnancy compared with 3% in the background population.2