EMEA says modafinil can only be used for treatment of narcolepsy; all other indications to be removed

23 July 2010

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

Modafinil is a wakefulness promoting agent, currently licensed in 21 countries in Europe, most notably as Provigil from USA-based Cephalon. It is also available under the brand names Modasomil, Modiodal and Vigil, and as well as a generic.

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