Provigil of Modest Benefit for Shift-Work Sleep Disorder - CME Teaching Brief - MedPage Today: "3-Provigil (modafinil), a stimulant with an unknown mechanism, has been found to be of modest benefit in treating excessive sleepiness associated with shift-work sleep disorder, yet more effective therapies are needed, researchers here reported.
In night shift workers, the drug led to a small but significant improvement in performance, compared with placebo, in the symptoms of sleepiness and performance on the job, but it did not restore sleepiness to normal daytime levels, said Charles A. Czeisler, M.D., Ph.D., of Harvard Medical School.
In a three-month, double-blind trial, 209 patients with shift-work sleep disorder were randomized to either 200 mg of Provigil or placebo before the start of each shift, Dr. Czeisler and colleagues reported in the Aug. 4 issue of The New England Journal of Medicine. Data were gathered via patient diaries and regular assessments with a variety of tests including the Clinical Global Impression of Change and the Psychomotor Vigilance test.
About 74% of patients in the treatment group reported improvement in their clinical symptoms, compared with 36% in the placebo group (P<.001). In addition, patients in the treatment group experienced reductions from baseline in the frequency and duration of lapses of attention during working hours while the placebo group experienced increases in frequency and duration of lapses (P<.001)."
those involved volunteers who were subjected to 60 hours of sleep deprivation. During their continued wakefulness, their vigilance was assessed using questionnaires, visual scales and sleep latency tests. The subjects received either 200 mg Modafinil or a placebo every 8 hours. The Modafinil group sustained a satisfactory level of vigilance with an absence of sleep episodes, unlike the placebo group who gradually declined and slipped into 'micro-sleep' episodes, (as one might expect when awake for longer than 24 hours). Another study conducted over 3 years discovered that Modafinil reduced drowsiness in 83% of hypersomniac patients and 71% of narcoleptics. Modafinil did not produce side effects, disturb night sleep, or promote drug dependence."
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