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Research Letter
September 1, 2020

Incidence of Malformations After Early Pregnancy Exposure to Modafinil in Sweden and Norway

Author Affiliations
  • 1Centre for Pharmacoepidemiology, Karolinska Institutet, Stockholm, Sweden
  • 2Department of Chronic Diseases and Aging, Norwegian Institute of Public Health, Bergen, Norway
  • 3Centre for Fertility and Health, Norwegian Institute of Public Health, Oslo, Norway
JAMA. 2020;324(9):895-897. doi:10.1001/jama.2020.9840

Modafinil is used to improve wakefulness in adults with excessive sleepiness due to narcolepsy, for fatigue related to multiple sclerosis, and for the treatment of attention-deficit/hyperactivity disorder. In 2018, an interim report from a manufacturer-established pregnancy registry reported a prevalence of 15% for major malformation in infants exposed to modafinil during pregnancy, spurring regulatory bodies to amend product information.1-3 Recently, a Danish study reported a major malformation rate of 12% (n = 6) among 49 infants exposed to modafinil during early pregnancy compared with 3.9% (n = 32 466) among 828 644 unexposed to modafinil (adjusted odd ratio, 2.7; 95% CI, 1.1-6.9).4 To add to the emerging evidence, we investigated if modafinil use during early pregnancy was associated with major malformations in Norway and Sweden.