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Prenatal Exposure to Modafinil and the Risk of Major Congenital Anomalies and Other Adverse Neonatal and Pediatric

Melinda Kanoun1,2, Naïm Bouazza1,2,3, Jean-Marc Treluyer1,2,3

  • 1Unité de Recherche Clinique Necker Cochin, AP-HP, Paris, France.

Pharmacoepidemiology and Drug Safety
|August 2, 2026
PubMed

Insights

Prenatal exposure to modafinil may be linked to a moderate risk of major congenital anomalies (MCAs), but no increased neurodevelopmental risks were observed in this large-scale study.

Area of Science:

  • Obstetrics and Gynecology
  • Pediatrics
  • Pharmacology

Background:

  • Prenatal exposure to medications requires careful risk assessment.
  • Modafinil is increasingly prescribed, necessitating evaluation of its safety during pregnancy.

Purpose of the Study:

  • To evaluate the association between prenatal modafinil exposure and major congenital anomalies (MCAs).
  • To assess risks of neurodevelopmental disorders (NDs) and specialized consultations following prenatal modafinil exposure.

Main Methods:

  • Retrospective cohort study using the French national healthcare database (SNDS).
  • Included singleton births between January 2009 and September 2024.
  • Compared modafinil-exposed children to methylphenidate-exposed and unexposed controls using propensity-score matching (PSM).

Main Results:

  • A statistically significant, though wide, increased risk of MCA was observed with first-trimester modafinil exposure compared to methylphenidate (aRR=1.77 [1.01-3.07]).
  • Comparison with unexposed controls showed a possible modest MCA risk increase, but the confidence interval crossed the null (aRR=1.23 [0.76-1.99]).
  • No significant association was found for neurodevelopmental disorders (NDs) or specialized consultations in modafinil-exposed children versus unexposed controls.

Conclusions:

  • A moderate risk of major congenital anomalies (MCAs) following prenatal modafinil exposure cannot be excluded.
  • No increased risk of neurodevelopmental disorders was identified.
Abstract

Keywords:
birth defectsnational healthcare databasepharmacoepidemiologypregnancyretrospective study

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