Drug Safety Update

Volume 4, Issue 1 August 2010

Latest advice for medicines users

Modafinil: European Medicines Agency recommends restricted use

Article date: August 2010

Modafinil (Provigil) is a wakefulness-promoting agent.

The European Medicines Agency has recommended that the use of modafinil should be restricted to treat only sleepiness associated with narcolepsy, and that it should no longer be used for the treatment of excessive sleepiness associated with obstructive sleep apnoea or chronic shift work sleep disorder.

On the basis of the available data, the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines only outweighed their risks in the therapeutic indication narcolepsy. For all other indications the Committee found that the risks outweighed the benefit shown in clinical trials. Therefore, the Committee concluded that all other indications should be withdrawn from the marketing authorisations of these medicines.

Further information is available from the European Medicines Agency website http://www.ema.europa.eu/ema/index.jsp

See also previous advice for modafinil from Drug Safety Update March 2008.


Article citation: Drug Safety Update Aug 2010, vol 3 issue 1: S1.


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Page last modified: 17 September 2010