January 27, 2004 WASHINGTON (AP) -- The Food and Drug Administration has approved a drug to help people with sleep disorders stay awake, the manufacturer said Monday.
Cephalon Inc., based in West Chester, Pa., said the FDA has approved the marketing of Provigil for patients who suffer from shift-work sleep disorder or obstructive apnea-hypopnea syndrome. Six million people in the United States work permanent or rotating night shifts and are at risk of shift work sleep disorder.
In 1998, Provigil became the first in a new class of wake-promoting agents approved in the United States for patients with narcolepsy. For those with obstructive sleep apnea/hypopnea syndrome, Provigil is approved as an aid to standard treatment for the underlying airway obstruction.
Obstructive sleep apnea/hypopnea syndrome is most commonly caused by airway obstruction -- usually the relaxation and collapse of the soft tissue in the back of the throat during sleep. About 12 million Americans suffer from the syndrome, according to the National Institutes of Health.
The approval of Provigil for these conditions provides clinicians with a therapeutic option to treat the excessive sleepiness that affects patients, said Dr. Paul Blake, senior vice president of clinical research and regulatory affairs at Cephalon.
Provigil promoted wakefulness in pre-clinical studies without causing generalized stimulation in the brain. The drug is thought to work selectively through the sleep and wake centers to activate the cortex of the brain. Activation of the cortex is essential for wakefulness.
The drug was used in clinical trials on more than 3,500 patients, and was well tolerated, the company said. Most adverse events were mild to moderate. Among them were headache, nausea, nervousness, stuffy nose, diarrhea and back pain.
Provigil has been shown to have no effect on the patient's ability to sleep when sleep is desired.
Copyright 2004 The Associated Press. All rights reserved.
