The MHRA published in the Drug Safety Update (Dec 2014, updated November 2020) an update on the safety of modafinil, in regard to its effect on unborn children. Modafinil potentially increases the risk of congenital malformations when used in pregnancy.

Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.

Modafinil was added to the PAD for non-licensed indications in 2014, and the initial MHRA alert was taken into consideration when the decisions were made.  Feedback from specialists is to retain the option to use in the non-narcolepsy approved indications on PAD.  See link to the MHRA information for further information   https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/936767/Nov-2020-DSU-PDF-1.pdf

Modafinil is not licensed for this indication. The PCN advised a RED traffic light status. There are a number of neurologists who may decide that modafinil is appropriate in a small cohort of patients in whom other treatments have been unsuccessful. In these circumstances, prescribing should remain with the specilaist.

Prescribe generically