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Medical News & Perspectives
January 14, 2004

Poised to Challenge Need for Sleep, "Wakefulness Enhancer" Rouses Concerns

JAMA. 2004;291(2):167-170. doi:10.1001/jama.291.2.167

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 both senses.

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 to Cephalon.