The licence for Provigil (modafinil) has been revised to restrict use of the drug to the treatment of excessive sleepiness associated with narcolepsy, with or without cataplexy.
The change to the licence follows a review by the Committee for Medicinal Products for Human Use (CHMP), which concluded that the potential adverse effects of modafinil (including skin or hypersensitivity reactions, cardiovascular disorders and neuropsychiatric symptoms) outweigh the clinical efficacy of the drug in obstructive sleep apnoea/hypopnoea syndrome and chronic shift work sleep disorder. Patients currently receiving Provigil for these indications should have their treatment reviewed at their next routine appointment.
The CHMP also made a number of other recommendations to support safer use of modafinil in narcolepsy, including a requirement for a baseline ECG prior to starting therapy, regular monitoring of cardiovascular function, in particular blood pressure and heart rate, and a starting dose of 200mg daily.
Further Information: Cephalon Ltd