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Elderly Say Sleep Improves With Eszopiclone: Presented at AGS

By Roberta Friedman

LAS VEGAS, NV -- May 21, 2004 -- Use of eszopiclone appears to improve the subjective quality and quantity of sleep in the elderly subjects with insomnia, according to findings from a randomized, double blind study.

Martin Scharf, PhD, of the Tri-State Sleep Disorders Center of Cincinnati, Ohio, presented these findings here May 21st at the American Geriatric Society Annual Meeting. The trial was part of the New Drug Application now before the United States Food and Drug Administration (FDA).

An earlier study reported earlier this year for elderly participants who underwent polysomnography testing found essentially identical findings to the current study, said Dr. Scharf.

A dose response was evident for sleep time in the current study, but not for latency to fall asleep. Both doses were equally effective in reducing sleep latency (P <.01). Sleep maintenance was improved by the 2 mg dose (P <.050).

The decline in sleep satisfaction among the elderly is primarily a result of fragmented sleep rather than the time it takes to initially fall asleep at the beginning of the night, Dr. Scharf said, adding, "the relationship [of sleep loss] to cognitive dysfunction is not appreciated enough by physicians."

The study analyzed self-reported sleep data from 143 patients 64 to 85 years of age, presenting to 32 sites in the U.S. Participants had insomnia diagnosed according to Diagnostic and Statistical Manual of Mental Disorder – Revision IV criteria. Two weeks of self reports after treatment with either 1 mg or 2 mg nightly were compared to placebo. Reports on awakening the next day, as well as evening reports on how the day went, were taken by an interactive voice response collection system.

Those on the active treatment rated their quality and depth of sleep as improved (P <.001 and P <.002, respectively). Morning sleepiness also declined (P =.055). "They slept better, and they felt better," Dr. Scharf said.

The number of naps subjects took throughout the day declined on average from 5 to 4, and the cumulative nap time was cut nearly in half by the 2 mg dose (145 with eszopiclone compared to 291 minutes for placebo; P <.01).

Side effects were mild, with headache reported by 15% of patients taking either placebo or active drug. The consistent difference was that people taking the active drug reported an unpleasant taste the next morning, which did not result in people dropping out of the trial. No falls were recorded during the study, Dr. Scharf said.

Eszopiclone is not a benzodiazepine. It binds to the GABA-A receptor, and does not affect cholinergic transmission, Dr. Scharf said.

The research was funded by Sepracor, the drug's maker, which received an approval letter from the FDA for eszopiclone under the trade name Estorra. The company expects approval by the end of the 2004.


[Presentation title: "Patient-reported efficacy of eszopiclone (ESZ) in elderly patients with chronic insomnia." Abstract A37.]

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