Marketed under the name of Modiodal, this drug prescribed against narcolepsy, as well as its generics, are suspected of being the cause of congenital malformations, alerts the Medicines Agency.
Used in the management of narcolepsy, modafinil should not be used during pregnancy. In a statementthe National Agency for the Safety of Medicines (ANSM), relays a warning from the European Medicines Agency which requests that “the risk of congenital malformations be added to the leaflet of the medicine”.
A rare sleep disorder, narcolepsy is characterized by bouts of drowsiness occurring suddenly during the day, often accompanied by attacks of loss of muscle tone.
Prioritize non-drug alternatives
People with narcolepsy can be prescribed modafanil, but only by neurologists or sleep centers. This treatment, marketed under the name Modiodal, is therefore now the subject of new recommendations for pregnant women after cases of malformations occurring in children in the United States are suspected of being linked to it, as well as to its generics.
Until now, it was specified in the instructions that Modiodal was “not recommended” during pregnancy. From now on, doctors are asked to “not prescribe modafinil in pregnant women and to favor non-drug alternatives (behavioral approaches, sleep hygiene and scheduled naps during the day)”.
The ANSM also specifies that “women of childbearing age and treated with modafinil must use effective contraception”, while advising them to use other contraceptive methods than those based on hormones (pills of any dosage confused, implants, hormonal IUDs and patches), the latter of which may be less effective because of modafinil.
Finally, the health agency recommends continuing contraception for two months after stopping modafinil treatment to rule out any risk of malformation in the event of pregnancy.
.
