ARTICLE | Clinical News

Provigil modafinil regulatory update

July 26, 2010 7:00 AM UTC

The European Medicines Agency's CHMP recommended 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. The committee also recommended that Provigil not be used in children and in patients with uncontrolled moderate to severe hypertension or cardiac arrhythmias. Cephalon plans to request a reexamination of CHMP's opinion. ...