ARTICLE | Clinical News

Provigil modafinil regulatory update

November 22, 2010 8:00 AM UTC

CHMP completed a re-examination procedure and reaffirmed a July recommendation limiting the use of sleep disorder drug Provigil modafinil based on safety concerns, including psychiatric disorders, subcutaneous tissue reactions, significant off-label use and a potential for abuse. The committee said Provigil should no longer be used for idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnea and chronic shift work sleep disorder, which would restrict its use to patients with narcolepsy (see BioCentury, July 26). CHMP is part of the European Medicines Agency (EMA). ...