Cephalon, Inc., has received approval to market modafinil (Provigil®) tablets to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome and “shift work sleep disorder.”
In 1998, modafinil became the first in a new class of wake-promoting agents for patients with narcolepsy.
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In preclinical studies, the drug promoted wakefulness without causing generalized stimulation in the brain. It seems to work selectively through the sleep-wake centers to activate the brain cortex. Activation of the cortex is essential for wakefulness.
The safety of modafinil was shown in clinical trials that enrolled more than 3,500 patients. The drug does not affect the ability to sleep when sleep is desired.