Broader Use of 'Stay-Awake' Pill Advised
FDA Advisory Panel Backs Use of Provigil for Several Sleep Disorders
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
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
But the committee was split on whether there was enough
evidence to support the manufacturer's claim for treating all sleep
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.