Pubdate: Wed, 29 Dec 1998 Source: San Jose Mercury News (CA) Contact: http://www.sjmercury.com/ Copyright: 1998 Mercury Center NARCOLEPSY DRUG OFFERS WIDE APPEAL WASHINGTON -- The Food and Drug Administration has approved a new drug that keeps people with debilitating sleepiness awake and attentive yet has few of the side effects associated with caffeine, amphetamines and other commonly used stimulants. The drug, modafinil, was approved for people with a serious sleep disorder called narcolepsy, which affects one out of 1,000 to 2,000 people, and is characterized by sudden, overwhelming waves of intense sleepiness. Modafinil will be available only by prescription, under the brand name Provigil, and will be listed by the Drug Enforcement Administration as a ``schedule IV'' substance, which means it will be regulated more tightly than most prescription drugs. Despite those restrictions, several experts said they would not be surprised if the pills quickly gained popularity among some of the millions of people who suffer from daytime sleepiness caused by problems more mundane than narcolepsy, such as overwork and stress-related insomnia. The drug may also find a ``gray market'' following among truck drivers, emergency room doctors and others whose jobs demand them to remain alert for days on end with little or no sleep. Preliminary studies on Canadian soldiers found that modafinil increased wakefulness and vigilance in soldiers who went without sleep for almost three days, without the agitation or the ``rebound'' fatigue that typically follows long stretches of amphetamine-induced wakefulness. No one knows yet whether modafinil is safe or effective for the vast majority of the world's fatigued. But clues may arise long before clinical trials are devised to study the question. Doctors who are licensed to prescribe scheduled drugs are allowed to prescribe those drugs for patients who do not have the disorder for which the FDA approved them. Experts said only time would tell whether doctors will feel comfortable prescribing modafinil to sleepy non-narcoleptics. If the DEA determines that the drug is being over-prescribed or abused, the agency can reschedule it to a more restrictive level. Cephalon, maker of the drug, announced modafinil's approval Monday, after getting word from the FDA on Thursday. Its stock jumped 12 percent, rising $1 to close at $9.19 on the Nasdaq. The drug is expected to become available in February. The company declined to reveal the price, but said it will be less than $10 a pill. - --- Checked-by: Rolf Ernst