For those of you who were unaware, Cephalon is anxiously awaiting FDA approval to sell Nuvigil, a slightly modified form of its Provigil narcolepsy pill, to combat jet-lag disorder. The drugmaker had hoped for a regulatory okay last month, but the agency delayed a decision in order to review data.

Ostensibly, Nuvigil would be aimed at eastbound business travelers, not folks with garden-variety sleep disorders, but as The New York Times notes, FDA approval would enable Cephalon to promote Nuvigil to a broad array of doctors, not just those who treat sleep disorders. “What a jet lag indication allows you to do is go to virtually every doctor,” Corey Davis, a Jefferies & Co. analyst, tells the paper, “because every physician will, at some point, treat a patient who will have jet lag.”

Not surprisingly, Cephalon is also trying to have Nuvigil approved for new uses beyond what Provigil is approved to treat. Provigil, meanwhile, faces generic competition in two years and the FTC sued Cephalon for paying off generic rivals (background here). Cephalon, however, raised the Provigil wholesale price to $13.60, from about $5.50 a pill five years ago, including a 29 percent increase in November, the Times tells us. So Provigil is now 50 percent more expensive than Nuvigil.

And so Cephalon will have to be careful. You may recall the drugmaker pleaded guilty in 2008 to a misdemeanor and paid $443 million to settle federal and state charges for promoting Provigil and two other drugs for unapproved uses (more background). Cephalon execs may need more than their own pills to keep their eyes wide open and stay out of trouble.