Stay-Awake Pill May Get Wider Approval

ByABC News via logo
October 8, 2003, 9:02 PM

Oct. 9 -- A powerful pill that helps patients feel like they got a good night's sleep, even if they didn't, may soon become more widely available.

Modafinil, sold under the name Provigil, was originally approved by the Food and Drug Administration in 1998 to treat narcolepsy, a serious condition in which people cannot stop falling asleep.

But since its introduction, the number of off-label prescriptions for Provigil has skyrocketed, with an estimated 80 percent of prescriptions for the drug going to night-shift workers, truck drivers, pilots and soldiers jobs in which it's crucial to remain awake and alert. Now the FDA may approve it for wider use a move that has met with some controversy.

"In the ethical debate, it's actually unethical for us not to help these patients," said Dr. James Wyatt, a sleep disorders specialist at Rush-Presbyterian-St. Luke's Medical Center in Chicago.

The pill has been found to increase both wakefulness and what researchers call "vigilance," the ability to stay on task, thinking clearly and functioning normally.

But some doctors fear that the pill may be abused and they worry about the impacts of long-term use.

"It could be used as a substitute for sleep, natural sleep, which we need to help heal our bodies in specific ways," said ABCNEWS' Dr. Tim Johnson. "It allows people to stay awake in ways that are addictive, and if that addiction is not sated, these people may have withdrawal symptoms."

Culturally Addictive?

There is no evidence that the pill produces classical psychological addiction, Johnson said. However, it is clear that for certain people staying awake too long and too often can be culturally and socially addictive.

"I think that we are a society that is sleep-deprived already, and I worry about the temptation to use this kind of pill to assist in staying awake," Johnson said. "We ultimately need to respect the deep value of sleep."

Still, the FDA is considering further approval.