Stay-Awake Pill May Get Wider Approval

ByABC News via logo

Oct. 9, 2003 -- 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. An advisory panel recently voted 6 to 2 in favor of Modafinil being used to treat chronic shift-work sleep disorder. They also voted 8 to 0 in favor of using the drug to treat daytime sleepiness caused by sleep apnea. A final ruling is expected to be made by the end of the month.

"It's not to treat short-term things like a student staying up overnight cramming for an exam," Wyatt said. "It's to be used in patients with chronic medical conditions where chronic daytime sleepiness or nighttime sleepiness poses a risk to their health and their safety."

Kandy Dodds, a mother of two who has worked the nightshift for eight years, sleeps about three to five hours each day. Dodds took part in a study conducted by Wyatt and said that the medicine helped her greatly.

"My co-workers would probably say that I'm more productive on the medication," Dodds said.

Without it, she feels tired in the early morning hours.

"Around 1 in the morning I was exhausted and I still had hours to go," Dodds said. "Coffee wasn't going to do it. I was a jelly bean eater and I tried jelly beans to sugar me up. You just are tired. "

Not Like a Cup of Joe

Wyatt points out that the drug does benefit this sub-group, but is careful to note that it does not work like caffeine.

"It works in a very select area of the brain called the hypothalamus, which regulates among other things sleep and wakefulness," Wyatt said. "And because it doesn't work in widespread areas of the brain, it seems to have a much cleaner side-effect profile, not producing nervousness or tremulousness or shakiness that other stimulants can."

There are some side effects, including headaches, nausea, infection, possible nervousness, anxiety and insomnia. But patients would see a limited number of those effects at one time, and they are actually less than the effects of caffeine. Dodds thought that the pill would have effects similar to caffeine, but she was surprised.

"I thought, OK, it's going to be like 10 cups of coffee," Dodds said. "It wasn't at all. I was really surprised. I wasn't tired. I mean, I felt tired like I had been working, but not like OK, it's halfway through, I'm almost there, I can almost sleep. It wasn't a radical improvement, but I just felt good, like you had slept all night and were up during the day."

Johnson said that there are legitimate uses of the drug, for people who are chronically on late shifts, and for patients with multiple sclerosis, who suffer from fatigue as a result.

"But I do think a broad use would be unethical for social reasons," Johnson said. "I personally would feel uncomfortable prescribing the drug to just anyone. We just don't know completely how it works, and we have limited experience with knowing what happens after long-term use."