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Brian Vastag

JAMA. 2004;291:167-170.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

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.

Competing with coffee? Sleep experts worry that a drug that improves wakefulness in patients with narcolepsy and a few other disorders will be used off-label by healthy individuals as a means to stint on sleep.

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.

A Washington Post article recently recommended it for jet-lag (and complained that it costs more than coffee). A . . . [Full Text of this Article]

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