Type A's perk up over modafinil, an anti-sleeping pill
Doctors be ready: A medication for sleep disorders is bound to attract interest from people who are just plain sleepy.
By Susan J. Landers, AMNews staff. Nov. 11, 2002.
Washington -- A surgeon awakens groggy after a restless night, feeling less than tip-top for a tricky, 12-hour procedure. A shift worker can't cope with the circadian chaos caused by working when sleep is called for. A Wall Street lawyer puts in the usual 14-hour day and a night of socializing and must bounce back to make million-dollar decisions in the morning.
All are sleep-deprived, and all could seek modafinil, a stimulant marketed in the United States under the name Provigil by Cephalon Inc., a biopharmaceutical company in West Chester, Pa. Used in Europe for several years, it was approved in late 1998 by the Food and Drug Administration for use by patients who have narcolepsy. But could this drug also be the answer for which some of those Type A's have been looking?
So far the medication has an admirable safety record. As word of its attributes spreads, it could be tapped as a support system for fast-paced lives -- and become a topic between patients and primary care physicians.
It is already prescribed off label for people with sleep apnea and depression, and studies have shown that it is effective for multiple sclerosis patients with excessive sleepiness.
The military is interested in modafinil, and a study at Fort Rucker in Alabama found that the drug boosted the performance of sleep-deprived helicopter pilots. But another study done at Walter Reed Army Institute of Research, Silver Spring, Md., found that while modafinil works, so do six cups of coffee.
Meanwhile, modafinil has become a big seller, with its sales doubling, $72 million to $150 million, from 2000 to 2001. The company is sponsoring studies intended to broaden the drug's appeal and further boost sales.
In late October, the company announced the results of its 12-week randomized, double-blind study of 209 patients with shift-work sleep disorder showing that modafinil significantly improved wakefulness.
The results will be used to support Cephalon's bid to expand FDA approval of the drug's use for this indication, said Frank Baldino Jr., PhD, company chair and CEO. The disorder is recognized in the International Classification of Sleep Disorders: Diagnostic and Coding Manual and is also classified as a circadian rhythm disorder by the American Psychiatric Assn.
But the inevitable question has arisen. If it works so well for people with sleep disorders, why not use it for people who are just plain sleepy?
Not so fast, specialists say. "People have to understand, this isn't better living through chemistry," said Thomas Roth, PhD, director of research at Henry Ford Medical Center in Detroit, which participated in Cephalon-sponsored studies of the drug.
While modafinil is a welcome treatment for patients with narcolepsy and certain other sleep disorders, its long-term use by healthy people is not encouraged. "I don't think people could support using something like modafinil long term in normal people based on what we know right now," said Meir Kryger, MD, director of the Sleep Disorders Center at the University of Manitoba, Canada.
"I feel very nervous about giving someone a treatment for something that is not a medical condition, but is a lifestyle thing," he added. Dr. Kryger doesn't prescribe modafinil for such patients.
But with the drug seemingly poised at the top of a slippery slope that could well lead to its use as a so-called lifestyle drug, physician prescribing patterns are key.
What primary care physicians should know about modafinil is an important issue, said Karl Doghramji, MD, director of the Sleep Disorders Center at Thomas Jefferson University Hospital in Philadelphia.
"If I correctly understand it, the company's future plans include the possibility of making an initiative to primary care physicians," he said. And the entry of primary care physicians into the sleep disorder picture would mean that many more patients would receive needed treatment, Dr. Doghramji said.
But with surveys showing that only about a half-hour of medical school training is devoted to sleep disorders, primary care physicians may face a steep learning curve, he noted.
"When do you, as a primary care physician, decide this patient has X disorder and go ahead and treat it, and when do you send the patient to a special center like a sleep disorders center?" he asked. "And if you do send a patient to a center, what do you do with the data you receive?"
Take it a case at a time
Decisions to use modafinil should be made on a patient-by-patient basis, said Neil B. Kavey, MD, director of the Sleep Disorders Center at New York Presbyterian Hospital/Columbia Presbyterian Medical Center.
While there will be some clear and proper uses for it, others will be a judgment call, said Dr. Kavey, who has prescribed the drug for off-label uses. "It's easy with the surgeon who is dealing with multiple traumas from accidents and who has to be up and up and up. You're going to give that surgeon Provigil."
But most agree that physicians would be very careful about prescribing modafinil solely to allow healthy patients to go for long periods without sleep. "I think most clinicians are very conservative in the use of medications," Dr. Roth said.
Safety is an issue, he said. Despite its good record, modafinil is a medication, he noted, and it is intended for specific disorders. After all, "do we give people diet pills so they can eat bacon burgers? Do we give people Lipitor so they can eat yolks?"
Carl E. Hunt, MD, agreed. "There is no substitute for a good night's sleep on a regular basis," said Dr. Hunt, who directs the National Center on Sleep Disorders Research, part of the National Institutes of Health.
The sleep center is fielding many questions regarding the use of modafinil for patients who do not have narcolepsy but who are chronically sleepy. "But there are no data that suggest that would be recommended or safe," Dr. Hunt said.
Modafinil's effect on such important physiologic benefits of sleep as learning and memory, mood and behavior, appetite and resistance to disease is unknown, Dr. Hunt said.
The most common explanation for people being sleepy is they are simply not getting enough sleep, he said. In that population, no sleep medicine physician would recommend using modafinil because of the concern about side effects. "The price we pay for using it could be much more serious than any possible benefit one might get," Dr. Hunt said.
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