Modafinil in First Trimester Associated with Birth Defects

By Amy Orciari Herman

Edited by David G. Fairchild, MD, MPH, and Lorenzo Di Francesco, MD, FACP, FHM

Use of the stimulant modafinil during the first trimester of pregnancy is associated with increased risk for congenital malformations, according to research reported in JAMA.

Using Danish registries, researchers identified roughly 50 pregnancies in which women received prescriptions for modafinil during the first trimester, 960 in which women were prescribed the stimulant methylphenidate, and nearly 830,000 unexposed pregnancies.

Major congenital malformations occurred in 12% of modafinil-exposed pregnancies, 4.5% of methylphenidate-exposed pregnancies, and 3.9% of unexposed pregnancies. After multivariable adjustment, modafinil was associated with significantly increased risk relative to methylphenidate or no exposure.

The researchers write, "Although further research is needed, women contemplating pregnancy should currently avoid or discontinue modafinil."