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Still, the F.D.A. admonished the company in January for advertising Provigil in journals, on Web sites and via handouts to doctors as a general remedy for sleepiness and fatigue rather than only for narcolepsy, and for understating the side effects.
Provigil, a drug from Cephalon that increases alertness, is approved only for narcolepsy, but most of its nearly $200 million in sales last year were for sleepiness linked to other conditions.
There should have been no excuse for sleepiness, given the cacophony that reverberated around Hampden, but when Gianluca Zambrotta took a quick throw-in from the left, the white shirts of the visitors were the only ones moving.
Street prostitution as practiced in Bonn, once the capital of West Germany and a town better known for sleepiness than sexiness, would be unfamiliar to many people outside Germany for its unusual degree of organization and institutionalization.
Cephalon hoped to get approval for sleepiness caused by all sleep disorders by showing that the drug worked in three representative conditions -- narcolepsy, shift work sleep disorder and sleep apnea, a condition in which people awaken briefly many times a night because their breathing stops.
For sleepiness, difficulty in finding the way, and type of distracting surrounding no significant difference was found.
Similar(36)
One hundred fifty-two (10%) children had at least one problem endorsed for daytime sleepiness, 138 (9%) for sleep duration, 132 (9%) for bedtime resistance, 112 (7%) for parasomnias, 106 (7%) for sleep anxiety, 83 (6%) for sleep onset delay, 45 (3%) for night wakening, and 16 (1%) for sleep-disordered breathing.
Examples are the use of quetiapine for psychosis, cholinesterase inhibitors for dementia, and modafinil for daytime sleepiness.
The respective scores (mean [SD]) for the ANEST and PENT groups were 3.6 (1.0) and 3.8 (0.5) for disturbed sleep, 3.7 (0.8) and 3.6 (0.7) for the sleepiness index, and 3.0 (0.9) and 3.0 (0.8) for the awakening index.
Provigil, which is short for "promotes vigilance," was approved late in 1998 for treatment of sleepiness associated with narcolepsy, a condition in which people fall asleep uncontrollably.
Some researchers are developing technology that watches drivers for signs of sleepiness.
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