Potential teratogenicity of modafinil - Conflicting evidence, need for research

• Published in: Gynécologie, obstétrique, fertilité & sénologie Vol. 51; no. 3; p. 186
• Main Authors: Marin, B, Arnulf, I, Latour, M, Vauzelle, C, Coulm, B, Beghin, D, Dauvilliers, Y, Elefant, E
• Format: Journal Article
• Language: French
• Published: France 01.03.2023
• Subjects: Central Nervous System Stimulants - adverse effects; Disorders of Excessive Somnolence - chemically induced; Disorders of Excessive Somnolence - complications; Disorders of Excessive Somnolence - drug therapy; Female; Humans; Idiopathic Hypersomnia - complications; Idiopathic Hypersomnia - drug therapy; Modafinil - adverse effects; Narcolepsy - drug therapy; Narcolepsy - etiology; Narcolepsie; Pregnancy; Grossesse; Major congenital malformation; Modafinil; Teratogenicity; Tératogénicité; Malformation congénitale majeure; Narcolepsy
• ISSN: 2468-7189; 2468-7189
• DOI: 10.1016/j.gofs.2023.01.003

Central disorders of hypersomnolence include narcolepsy type 1, narcolepsy type 2, idiopathic hypersomnia and hypersomnia associated with medical or mental disorders. Treatment is both non-pharmacological and pharmacological, including wake enhancing drugs and stimulants. One of the first-line treatment (modafinil, MODIODAL®) was the subject of a health authority alert in 2019 concerning a risk of major congenital malformations when taken during organogenesis. Since this date, three epidemiological studies have presented contradictory results. Given their methodological weaknesses, it is not possible at this stage to confirm or deny such a risk for the embryo and its nature if there is one. In clinical practice, because of these uncertainties, it is preferable if possible to suspend the treatment of a pregnant woman during the first 10 weeks from last menstrual period (organogenesis). There is an unmet clinical need for research to clarify the potential teratogenic impact of modafinil.