Regulators in the European Union aren't impressed with Provigil as a multipurpose wakefulness remedy. The European Medicines Agency has recommended new restrictions on the use of the Cephalon drug. Provigil should be used only to treat narcolepsy, the regulators say, because the benefits for other indications may not be worth the risks.
The regulators had been reviewing Provigil safety, worried about reports of various side effects, including psychiatric trouble and skin reactions. The EMA is also concerned about widespread off-label use of Provigil--and the potential for its abuse.
However, Cephalon backs the safety of the drug: "Modafinil has been used safely and effectively for its licensed indications in Europe for many years and we believe the risk/benefit profile in all approved indications is positive," Cephalon spokeswoman Candace Steele Flippin says, as quoted by Reuters.
Provigil was originally approved to treat narcolepsy, but later won indications for idiopathic hypersomnia, excessive sleepiness associated with obstructive sleep apnea and chronic shift work sleep disorder. It's these latter uses the EMA says should be withdrawn. But the restricted use isn't final: The EMA's recommendations await approval by the European Commission.
- read the EMA release
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