On July 22, 2010, the European Medicines Agency recommended restricting the use of modafinil. Doctors and patients should be advised to use the drug only for the treatment of narcolepsy and all other indications should be withdrawn from market authorization, the press release said.
In addition to the brand-name, Provigil, marketed by Cephalon in the US, modafinil is also sold as Alertec, Modalert, Modavigil, Modiodal, Provake, and Vigil.
A review by the Agency's Committee for Medicinal Products for Human Use (CHMP), began in May 2009, because of safety concerns relating to psychiatric disorders, such as suicidal thoughts, depression, and psychotic episodes, and life threatening skin reactions, as well as significant off-label use and potential for abuse.
CHMP looked at all the clinical trial data on modafinil for narcolepsy, obstructive sleep apnoea, shift-work sleep disorder and idiopathic hypersomnia, and articles from the published literature. CHMP also reviewed all the side effects reported on modafinil-containing medicines, and convened a group of experts on clinical neurosciences to provide advice, according to a Q&A document on EMA's website.
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