WINSTON-SALEM, N.C. – The drug eszopiclone, marketed as Lunesta™, significantly improved sleep in elderly people with chronic insomnia, according to a report by W. Vaughn McCall, M.D., M.S., and six colleagues.
“Eszopiclone was well tolerated and significantly improved sleep onset, sleep efficiency, total sleep time and sleep quality over the study period,” said McCall, director of the sleep laboratory at Wake Forest University Baptist Medical Center and professor and chairman of the Department of Psychiatry and Behavioral Medicine, in the study published in Current Medical Research and Opinion.
He said eszopiclone significantly reduced wakefulness after sleep had begun, wake time during the sleep period and daytime napping.
McCall said daytime napping was more common in elderly patients with insomnia than in good sleepers and that napping increases with age. “The finding of less daytime napping associated with eszopiclone treatment in the present study could be interpreted as evidence of improvement in some aspects of daytime function in these elderly insomniacs.”
The study compared eszopiclone with an inert placebo in patients 64 to 86 years old over a two-week period and used both measurements made in sleep laboratories and patients’ own reports of their sleep activity during the study.
The 136 patients in the eszopiclone group reported greater quality of sleep and greater depth of sleep than the 128 patients in the control group, he said. “Upon awakening, patients treated with eszopiclone reported less morning sleepiness compared with placebo.”
Since patients were in the study for only two weeks, McCall said longer-term studies are needed to determine the safety of longer treatment. The study – conducted in 49 sleep laboratories -- was the largest sleep-lab-based trial of nightly doses of a sleeping pill in elderly patients with insomnia, he said.
“Chronic insomnia is an under-recognized, under-diagnosed and under-treated disorder that is not only more prevalent in the elderly than the general population, but also potentially serious, as it can be associated with increased risk for injurious falls and impairment of cognitive function, which can be misdiagnosed as dementia,” McCall and his colleagues said. “In patients with dementia, insomnia is also the most frequently cited reason for nursing home placement.”
The study was paid for by Sepracor Inc. as part of a new drug submission to the U.S. Food and Drug Administration (FDA). (McCall also has been an advisor to Sepracor.) The FDA has already approved the drug for treatment of insomnia.
The other authors included Milton Erman, Ph.D., of Pacific Sleep Medicine Services in San Diego, Calif., Andrew D. Krystal, M.D., M.S., of Duke University Medical Center, Russell Rosenberg, Ph.D., of Northside Hospital in Atlanta, Martin Scharf. Ph.D., of Tristate Sleep Disorders Center in Cincinnati, Ohio, Gary K. Zammit, Ph.D., of Columbia University College of Physicians and Surgeons in New York and Thomas Wessel, M.D., of Sepracor, Inc.
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Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.