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In a 3-month study, Dr. Charles A. Czeisler from Harvard Medical School in Boston and colleagues randomly assigned 209 shift-workers with chronic sleep disorder to take Provigil (known generically as modafinil) or an inactive “placebo” before the start of each shift. One hundred fifty-three participants completed the study.
The researchers report in the New England Journal of Medicine that modafinil, compared with placebo, reduced the “extreme sleepiness” observed in study subjects and led to a “small but significant” improvement in performance.
“The improvement with modafinil in shift-work sleep disorder patients was comparable to the improvement with modafinil in patients with Narcolepsy,” Czeisler commented to Reuters Health.
Modafinil did not have an adverse impact on daytime sleep, he added.
“Despite these benefits, patients treated with modafinil continued to have high levels of sleepiness and impaired performance at night,” the authors note in their report. This “underscores the need for the development of interventions that are even more effective” for this large underrecognized population of people with shift-work sleep disorder.
In a related editorial, Dr. Robert C. Basner, from Columbia University College of Physicians and Surgeons in New York, notes that the study “does not adequately assess the clinical value of this particular drug in shift-work sleep disorder, nor does it justify writing more prescriptions for modafinil.”
“Rather, it serves as a wake-up call for the design and implementation of further scientific studies to address in a cohesive manner the serious health and safety issues that surround us by virtue of our having become, to a large extent, a shift-working society,” Basner writes.
With further study, modafinil “may well be shown to be an effective and safe” addition to the treatment of shift-work sleep disorder, he adds.
SOURCE: New England Journal of Medicine, August 4, 2005.