Non-addicting drug offers narcolepsy sufferers safe option

March 12, 2000

ST. PAUL, MN - Modafinil, the first nonaddicting drug for people suffering from narcolepsy, offers safe and effective relief from excessive daytime sleepiness associated with the disorder, according to a study published in the March 14 issue of Neurology, the American Academy of Neurology's scientific journal. The study is the first to verify that modafinil does not create dependency or lingering withdrawal symptoms.

"Modafinil represents a significant advance in the treatment of narcolepsy and offers patients an excellent alternative to current treatments," said neurologist Paul Gross, MD, the study's corresponding author and neurology chairman at Lahey Clinic in Burlington, MA, and associate professor of neurology at Tufts University in Boston. "Previous treatments for narcolepsy required the use of amphetamines and amphetamine-like stimulant drugs. Stimulants can cause high blood pressure, altered heart rhythms and anxiety and may lead to drug dependency. This creates the potential for serious withdrawal symptoms when patients stop taking the drug."

Researchers studied 271 patients at 21 U.S. medical centers for nine weeks. Patients received either 200 mg of modafinil, 400 mg of modafinil or placebo (inactive pill) daily. For an additional two weeks researchers continued to monitor the patients who were taken off modafinil to evaluate the drug's withdrawal effects on patients.

Patients receiving the 200 mg or the 400 mg dose of modafinil showed similar improvement in the ability to stay awake longer during inactivity compared to those receiving placebo. Patients were asked to sit in a darkened room and try to remain awake. Patients were able to remain awake longer after taking modafinil. Patients taking modafinil also reported that they felt significantly less sleepy during their normal daily activities.

Patients had no withdrawal symptoms when they stopped taking modafinil and returned to their previous level of sleepiness. Those receiving modafinil reported a slight increase in headache and nausea, but when compared to patients taking placebo the increase was not significantly higher. No other related side effects were noted and nighttime sleep was not disturbed by the treatment.

Gross cautions that modafinil may affect the efficacy and dosage levels needed for other prescription medications, including oral contraceptives. Women taking modafinil should discuss this with their physicians and may need to switch to higher dose birth control pills, he said.

"While modafinil significantly improves alertness and has advantages over existing therapies, we must keep in mind that no treatment for narcolepsy can completely resolve its symptoms," Gross said. "Further research and study of this life-altering disorder is required."

Narcolepsy affects the sleep and wake cycle, often causing excessive daytime sleepiness. The disorder is often inherited, with symptoms normally appearing in the teenage years. About one in 2,000 people are believed to have narcolepsy, with males, females and most racial groups equally affected.

This study was funded by a grant from Cephalon, Inc., which manufactures modafinil.
The American Academy of Neurology, an association of more than 16,500 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research.

Editor's Note: Join the American Academy of Neurology in celebrating the progress and promise of brain research during Brain Awareness Week 2000, March 13-19. Brain Awareness Week is an international effort organized by the Dana Alliance for Brain Initiatives and its many partners including the American Academy of Neurology, the National Institutes of Health, and numerous other worldwide government agencies, hospitals, universities, and professional and patient organizations.

American Academy of Neurology

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