Rise and Shine: New Drug for Treatment of Daytime Sleepiness Caused by Narcolepsy

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March 13, 2000 (New York) -- A new drug, modafinil, helps people who suffer from narcolepsy feel less sleepy and stay awake longer. The drug appears to avoid some of the pitfalls associated with the use of stimulants, like amphetamines, which are the traditional medications used to treat the condition, according to a report in the March issue of the journal Neurology.

"Narcolepsy is an important condition that affects one in 2,000 people," study co-author Paul T. Gross, MD, tells WebMD. "It's an underdiagnosed condition because the main symptom is sleepiness and everybody gets sleepy at times. But there are people who have significant pathological sleepiness that is over and above what the average person would expect, and it interferes with their daily lives."

In addition to abnormal sleepiness, narcolepsy is characterized by sudden attacks in which people are unable to move their bodies and therefore fall down, attacks of paralysis while they are trying to sleep, and hallucinations.

The study was conducted at 21 centers across the U.S. Patients had been previously diagnosed with narcolepsy and most were considered moderately to severely ill by their physicians. Participants were randomly assigned to receive modafinil 200 mg per day, modafinil 400 mg per day, or a placebo (sugar pill) for nine weeks. Neither the investigators nor the patients knew which medication the patient was taking.

During treatment with modafinil, patients tended to be more able to stay awake and less likely to fall asleep than with placebo. Patients also said they felt significantly less sleepy after nine weeks of modafinil treatment.

About 60% of the patients were rated on one test by their doctors as significantly improved with modafinil at both the 200 mg dose and the 400 mg dose compared with those who received a placebo. Nearly 40% of the patients in the placebo group were rated as significantly improved. Modafinil also appeared to be well tolerated and safe.

Laboratory measurements indicated that modafinil did not disturb nighttime sleep. Most side effects were mild to moderate in severity, and the most frequent side effects were headache and nausea. However, modafinil may enhance the metabolism of oral contraceptives if taken at the same time. This might require an increase in the dosage of the oral contraceptive for it to remain effective.