Is the 'Awake Pill' the Real Deal?

"20/20" obtained a copy of a Provigil sales report. Allergists, internists, pediatricians and even dentists are prescribing the "awake pill." It's being used to treat excessive sleepiness in depression, multiple sclerosis, hyperactivity and cancer. It might lead you to think that Provigil is an amazing breakthrough, but a closer look raises questions.

Public Disclosure

Dr. Charles Czeisler, chief of sleep medicine at Brigham and Women's Hospital, was the lead investigator of the Provigil shift-work study, where one group got a placebo, and one got Provigil.

Czeisler makes it clear that he has served as a paid consultant to Cephalon. He says modafinil -- the generic name for Provigil -- "was shown to significantly improve the alertness and performance of those people."

The study shows that the "awake pill" kept participants awake 1.7 minutes longer than the placebo. A modest finding, at best. But in 2003, Czeisler appeared before the FDA on behalf of Cephalon to lobby for the approval of the drug.

Eight months later, Cephalon gave Harvard nearly $3 million to establish a chair in sleep medicine, with Czeisler as the first recipient.

"I think the public should worry about any issue of conflict of interest," Czeisler said. "And I think the first step toward resolving those issues is to make them public. That's why anytime I publish a paper there is a long list of any company with which I am interacting, including Cephalon."

It's called public disclosure, and it's in the small print at the end of Czeisler's study. But Kassirer says disclosure is a weak safeguard for the public: a watchdog with no teeth.

"Disclosure is not an ideal solution," he said. "The problem with disclosure is you just don't know what to do about it. A better solution is to have plenty of people evaluating clinical information who are not conflicted."

The Caffeine Comparison

"20/20" set out to discover how well Provigil worked when the studies were not funded by Cephalon.

That led us to the sleep labs of the U.S. Army. Brain scientist Nancy Wesensten studies drugs to help sleep-deprived soldiers stay awake and alert. She didn't just compare Provigil to a placebo, she compared it to America's No. 1 selling "awake drug": caffeine.

"We knew that caffeine was an effective means for sustaining performance during sleep loss," she said. "But we are always looking for other compounds that might be an improvement on caffeine, so when modafinil came along we wanted to compare modafinil to caffeine."

Wesensten compared Provigil to caffeine in terms of how well the soldiers performed on tests and how alert they were, and she also looked at side effects. The result?

"In our hands, at the dosages we tested, modafinil did not work any better than caffeine," she said.

In fact, the Army found that Provigil worked no better than the amount of caffeine you received in a big cup of Starbucks coffee. But soldiers on the battlefield don't get their caffeine in a cup of coffee, they use caffeine gum for low doses across many hours.

Whether you're getting your kick from a pill or a cup of coffee, at the end of the day, all the experts say the best answer for sleepiness is the oldest one. As Wesensten puts it:

"The ultimate cure is sleep. Nothing replaces sleep."

Cephalon issued a response to ABC's coverage of this story:

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