Last January, drug maker Cephalon made an unusual request. It wanted
the Food and Drug Administration (FDA) to approve a drug not for a condition
or a disease, but for a symptom: sleepiness.
Not just routine sleepiness, but excessive, or in the words of one Cephalon
advisor, "profound" sleepiness. The kind that makes drivers crash—in
Marketed as Provigil, modafinil was approved for the treatment of narcolepsy
in 1998. Since then, though, the drug has earned a reputation as an all-around
pick-me-up, with roughly 90% of prescriptions going for off-label uses, according
Vastag B. Poised to Challenge Need for Sleep, "Wakefulness Enhancer" Rouses Concerns. JAMA. 2004;291(2):167–170. doi:10.1001/jama.291.2.167
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