Pubdate: Wed, 29 Dec 1998
Source: San Jose Mercury News (CA)
Copyright: 1998 Mercury Center


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