Broader Use of 'Stay-Awake' Pill Advised

FDA Advisory Panel Backs Use of Provigil for Several Sleep Disorders

From the WebMD Archives

Sept. 26, 2003 -- Workers who have trouble adjusting to a new shift may soon have something more potent than coffee to turn to when they can't stay awake.

An FDA advisory panel has recommended wider use of a drug traditionally used to treat daytime sleepiness associated with the sleep disorder narcolepsy.

The committee recommended that the drug, Provigil, be used to treat excessive sleepiness caused by either changes in work schedules or by the sleep disorder known as obstructive sleep apnea (OSA) or sleep-disordered breathing.

But the committee was split on whether there was enough evidence to support the manufacturer's claim for treating all sleep disorders.

The FDA is not required to follow the recommendations of the advisory panel, but it usually does. Final FDA decision on using Provigil for these purposes is expected by Oct. 20.

More Help to Stay Awake

The committee voted in favor of expanding the use of Provigil to treat sleep disruption or daytime sleepiness caused by a condition called shift work sleep disorder. This condition is caused by altering the body's natural sleep-wake cycle known as the circadian rhythm.

In addition, the panel endorsed the use of Provigil to treat excessive sleepiness caused by obstructive sleep apnea. Sleep apnea is also commonly associated with snoring.

Researchers say the stimulant can help keep people awake with fewer side effects than caffeine or amphetamines.

But committee members at the meeting yesterday expressed fears that the drug may be overprescribed if it were approved to treat excessive sleepiness caused by all sleeping disorders, according to a group that monitors FDA advisory committee meetings.

The FDA approved Provigil in 1998 to reduce daytime sleepiness in people with narcolepsy.

Potential side effects of the drug include headache, infection, nausea, nervousness, feeling anxious, and trouble sleeping.

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Sources

SOURCES: FDA. FDAadvisorycommittee.com, published by FDC report, a division of Elsevier Science, Sept. 25, 2003.

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