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.
-end-
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

Related Sleep Articles from Brightsurf:

Size and sleep: New research reveals why little things sleep longer
Using data from humans and other mammals, a team of scientists including researchers from the Santa Fe Institute has developed one of the first quantitative models that explains why sleep times across species and during development decrease as brains get bigger.

Wind turbine noise affects dream sleep and perceived sleep restoration
Wind turbine noise (WTN) influences people's perception of the restorative effects of sleep, and also has a small but significant effect on dream sleep, otherwise known as REM (rapid eye movement) sleep, a study at the University of Gothenburg, Sweden, shows.

To sleep deeply: The brainstem neurons that regulate non-REM sleep
University of Tsukuba researchers identified neurons that promote non-REM sleep in the brainstem in mice.

Chronic opioid therapy can disrupt sleep, increase risk of sleep disorders
Patients and medical providers should be aware that chronic opioid use can interfere with sleep by reducing sleep efficiency and increasing the risk of sleep-disordered breathing, according to a position statement from the American Academy of Sleep Medicine.

'Short sleep' gene prevents memory deficits associated with sleep deprivation
The UCSF scientists who identified the two known human genes that promote 'natural short sleep' -- nightly sleep that lasts just four to six hours but leaves people feeling well-rested -- have now discovered a third, and it's also the first gene that's ever been shown to prevent the memory deficits that normally accompany sleep deprivation.

Short sleep duration and sleep variability blunt weight loss
High sleep variability and short sleep duration are associated with difficulties in losing weight and body fat.

Nurses have an increased risk of sleep disorders and sleep deprivation
According to preliminary results of a new study, there is a high prevalence of insufficient sleep and symptoms of common sleep disorders among medical center nurses.

Common sleep myths compromise good sleep and health
People often say they can get by on five or fewer hours of sleep, that snoring is harmless, and that having a drink helps you to fall asleep.

Sleep tight! Researchers identify the beneficial role of sleep
Why do animals sleep? Why do humans 'waste' a third of their lives sleeping?

Does extra sleep on the weekends repay your sleep debt? No, researchers say
Insufficient sleep and untreated sleep disorders put people at increased risk for metabolic problems, including obesity and diabetes.

Read More: Sleep News and Sleep Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.