March 19, 1999

The Food and Drug Administration (FDA) has approved a nonamphetamine medication, modafinal, for treatment of narcolepsy.

The drug will be marketed under the trade name Provigil. It is the first nonamphetamine product approved for promoting wakefulness in 40 years, according to the drug's manufacturer, Cephalon.

Although not an amphetamine, the drug's capacity to prolong wakefulness has led the Drug Enforcement Administration to propose that Provigil be designated a Schedule IV controlled substance. The drug is expected to be available for prescribing sometime this month.

Narcolepsy afflicts an estimated 1 in 2,000 Americans, according to the Stanford University School of Medicine Center for Narcolepsy. It is a chronic, lifelong neurological sleep disorder that generally first shows up during adolescence. The great majority of narcoleptic sufferers in the U.S. are undiagnosed. The mean number of years between onset of narcolepsy and correct diagnosis is 14 years, according to one recent study cited on the center's Web site.

Provigil is contraindicated in patients with a history of left ventricular hypertrophy, ischemic electrocardiograph changes, chest pain, arrhythmia, or other clinically significant indications of mitral valve prolapse associated with central nervous system stimulant use.

Full prescribing information is available from Cephalon at (800) 896-5855 or on the Internet at www.provigil.com.

Patients seeking information on narcolepsy or excessive daytime sleepiness can call (888) 41-AWAKE.

The Web site address of Stanford's Center for Narcolepsy is www.med.stanford.edu/school/Psychiatry/narcolepsy/main.html.

The online version of the Narcolepsy & Sleep Disorders Newsletter may be found at www.narcolepsy.com/.