New sleep drug Provigil generates controversy

by Carl Burnett | 5/16/02 5:00am

Touted by some as a wonder drug that can replace sleep, a relatively new drug called Provigil has failed to win widespread support from the medical community as anything more than a treatment for some sleep disorders.

The drug, scientifically known as modafinil, was developed in France in the 1970s, but it was not tested in the United States until the 1990s.

In 1998, the U.S. Food and Drug Administration approved use of modafinil to treat narcolepsy, a disorder characterized by uncontrollable sleepiness. West Chester, Pa.-based pharmaceutical company Cephalon began marketing the drug domestically under the name Provigil in 1999.

Provigil seems to increase alertness and wakefulness not just in patients with narcolepsy, but also for people with other ailments that cause sleepiness or fatigue, like sleep apnea, multiple sclerosis, Parkinson's disease, bipolar disorder and depression.

Unlike stimulants like caffeine or amphetamines, Provigil appears to affect only certain parts of the brain, rather than the entire central nervous system.

Provigil's side effects are minimal; headache and insomnia are the most common, according to Dr. Glen Greenough, an assistant professor of psychiatry and neurology at Dartmouth who treats sleep disorders.

While the drug has not yet been approved to treat ailments other than narcolepsy, physicians may legally prescribe it "off-label" for other purposes.

Cephalon is eager to promote the drug for other uses, and has drawn fire by some in the medical community for its advertising to doctors, which included the suggestion, "Consider Provigil to improve wakefulness." Critics say such language encourages irresponsible prescriptions for non-approved uses.

Cephalon has not, however, pressed the FDA to approve Provigil for over-the-counter use, and some doctors see that as unlikely.

"I would be very surprised if it were to go over-the-counter," said Oneil Bains, a doctor specializing in sleep disorders at Stanford University. "Drugs like this don't become over-the-counter because of the high abuse potential."

Although Provigil is not addictive and unlike stimulants may not even require "rebound sleep," Greenough said the effects of avoiding sleep are poorly understood.

What's more, he said, a drug may win FDA approval after success in a test group, but problems may still arise when more people take the drug.

Bains did see potential for limited use of the drug by people in positions that demand alertness, such as pilots, truck drivers and soldiers.

Studies conducted by the U.S. and Canadian governments have found that pilots taking Provigil were able to perform well on complex cognitive tasks even after days without sleep.

"Those kinds of uses are more responsible," Baines said. "With a college student that's sleep-deprived, you know the problem: they need sleep."

Dartmouth student Eugenia Albina '03 agreed, saying "The solution to sleepiness is sleep. [Provigil] just covers up the problem."

Albina said she would "never, ever, ever" take Provigil even if it were approved by the FDA.

Mike Angelicola '04, however, saw few problems with the drug. Sipping a large cup of coffee, he said he would use Provigil "maybe three times a week, if it meant I could get four hours of sleep instead of six."