Modafinil receives expanded indication

Main Category: Sleep / Sleep Disorders / Insomnia
Article Date: 02 Feb 2004 - 0:00 PDT


Agent cleared for helping workers tired from sleep apnea, shift work.

Modafinil (Provigil-Cephalon) has received an expanded indication for improving wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea (OSA) and shift work sleep disorder (SWSD).

The drug was originally approved by FDA in 1998 to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. In a separate development, a generic formulation of modafinil has been approved.

OSA is marked by breathing interruptions caused by the closing off of the airway during sleep that cause awakenings. The condition is linked with excess body weight, especially fat under the chin.

SWSD is primarily experienced by people working at night or individuals on schedules that require them to work and sleep at irregular times. For instance, a health care worker on a schedule such as 8 am to 4 pm Monday and Tuesday and 12 to 8 am Thursday and Friday would be prone to SWSD.

Modafinil is in pregnancy category C. It should only be used in pregnant or nursing women if the benefits outweigh the risks.

Also, coadministration of modafinil and drugs that are substrates, inhibitors, or inducers of the cytochrome P450 isoenzymes may lead to reductions in plasma concentrations of modafinil.

In other news, Barr Laboratories has announced that FDA granted tentative approval for its generic version of modafinil.

As explained in a NewsRx.com wire story on the FDA action, "A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily improved non-approval periods.

A tentative approval does not allow the applicant to market the generic drug product." Cephalon's modafinil product lost its market exclusivity as an orphan drug late last December but retains its exclusivity protection as a new chemical entity until December 24, 2005.

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