European Medicines Agency – Restriction to the Use of Modafinil

On 22 July, 2010 the European Medicines Agency recommended restricting the use of modafinil.

Doctors and patients are advised to use modafinil for treatment of narcolepsy only; all other indications to be removed from product information

The European Medicines Agency has recommended restricting the use of modafinil-containing medicines. The medicine should only be used to treat sleepiness associated with narcolepsy. Doctors and patients should no longer use the medicine for the treatment of idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnoea and chronic shift work sleep disorder.

The review by the Agency’s Committee for Medicinal Products for Human Use (CHMP) was initiated because of a number of safety concerns, relating to psychiatric disorders, skin and subcutaneous tissue reactions as well as significant off-label use and potential for abuse.

On the basis of the available data the Committee concluded that the benefits of these medicines only outweighed their risks in the therapeutic indication narcolepsy, a chronic sleep disorder characterised by excessive daytime sleepiness. For all other indications the Committee found that the risk for development of skin or hypersensitivity reactions and neuropsychiatric disorders outweighed the evidence for clinically important efficacy. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorisations of these medicines.

The SMC Advice has been removed from the website.

Medicine details

Medicine name:
modafinil (Provigil)
Excessive sleepiness associated with obstructive sleep apnoea / hypopnoea syndrome
Pharmaceutical company
Cephalon UK Ltd
BNF chapter
Central nervous system
Submission type
Date advice published:
13 March 2006