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Eszopiclone Study Demonstrates Improved Wake-Time After Sleep Onset in Patients With Insomnia
This study included patients who were 21 to 69 years of age, met DSM-IV(1) criteria for primary insomnia, and reported a total sleep time of less than 6.5 hours each night and/or a time to sleep onset of more than 30 minutes. Patients in this study were not required to have a sleep maintenance problem. Since the six-month randomized, double-blind, placebo-controlled, multi-center study of eszopiclone did not require subjects to have sleep maintenance problems in order to participate, a re-analysis of the data was carried out to better determine if the compound improved sleep in those patients with difficulties staying asleep. The data were re-analyzed to determine the extent to which pre-treatment WASO affected the degree to which eszopiclone improved WASO as compared to placebo.
Results showed that eszopiclone improved sleep maintenance irrespective of the level of pre-treatment WASO and that greater improvement was evident in those with greater baseline severity. Analysis included stratifying subjects into subgroups on the basis of baseline WASO. Subjects were grouped into a low WASO group (=60 minutes) or a high WASO group (60 minutes). In the low WASO group, treatment with eszopiclone (n=320) resulted in a median WASO of 16.5 minutes compared to a median WASO of 25.4 minutes for patients given placebo (n=111; p=0.0035). In the high WASO group, the median WASO following treatment with eszopiclone (n=189) was 37.5 minutes compared with 65.0 minutes when treated with placebo (n=55; p=0.0033).
"The re-analysis of the data demonstrated that eszopiclone improved WASO across the range of pre-treatment severities studied, and the improvement was greatest in subjects who had the greatest difficulty staying asleep. These findings reinforce my belief in the capacity of eszopiclone to help those patients with sleep maintenance problems," said Andrew Krystal, M.D.
According to the National Institutes of Health web site, insomnia affects more than 50 million Americans. Symptoms of insomnia include difficulty falling asleep, awakening frequently during the night, waking up too early, an inability to fall back to sleep, or awakening feeling unrefreshed.
According to the National Sleep Foundation (NSF) Sleep in America Poll 2003, 37 million older Americans suffer from frequent sleep problems that, if ignored, can complicate the treatment of a host of common, serious, age-related medical conditions, from arthritis to diabetes, heart and lung disease and depression. The NSF's poll shows that poor sleep among older adults often goes unnoticed by the medical community. Although the majority of older adults (67%) report frequent sleep problems, only about seven million elderly patients have been diagnosed with insomnia.
On February 27, 2004, Sepracor received an "approvable" letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for ESTORRA for the treatment of insomnia characterized by difficulty falling asleep and/or difficulty maintaining sleep during the night and early morning.
Contingent upon approval from the FDA of the Estorra NDA, Sepracor would expect the recommended dosing to achieve sleep onset and maintenance to be 2 mg and 3 mg for adult patients, 2 mg for elderly patients with sleep maintenance difficulties, and 1 mg for elderly patients whose primary complaint is difficulty falling asleep. The FDA has not requested additional clinical or preclinical trials for approval.
The NDA contains a total of 24 clinical trials, which included more than 2,700 adult and elderly subjects, and more than 60 preclinical studies. A total of six randomized, placebo-controlled Phase III studies for the treatment of chronic or transient insomnia were conducted in both adult and elderly patients and were part of the NDA package.
The U.S. market for prescription sleep products, not including off-label use of central nervous system agents not indicated for the treatment of insomnia, was approximately $1.8 billion in 2003.