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| |  DG DISPATCH - APSS: Benefits Of Zaleplon For Primary Insomnia Maintained Over Time By Jill Stein Special to DG News
LAS VEGAS, NV -- June 19, 2000 -- Investigators have confirmed the long-term efficacy, tolerability and safety of zaleplon for primary insomnia. The data were presented at the 14th Annual Meeting of the Associated Professional Sleep Societies by Martin Scharf, MD, with the Center of Research in Sleep Disorders in Cincinnati, OH. His group conducted a 35-night, sleep laboratory study in out-patients with primary insomnia. All patients initially received placebo and underwent a polysomnographic (PSG) screening period. Treatment included zaleplon 10 mg or placebo 30 minutes before "lights out" at a sleep laboratory or just before going to bed at home. Patients returned to the sleep laboratory for nightly PSG recordings on 10 days during the one-month study period. At home, patients completed a post-sleep questionnaire. There was a two-night placebo run-out phase after treatment. Results were available in 96 patients. Dr. Scharf reported that latency to persistent sleep was significantly shorter in zaleplon-treated patients than in placebo patients at week one through five. Zaleplon reduced median latency to persistent sleep by 17 minutes after one week of treatment (from 44 minutes at baseline to 27 minutes at week one), and this decrease was maintained for all five weeks. Results of patient questionnaires confirmed the PSG findings. Median time to sleep onset while in the sleep laboratory and at home was significantly shorter in the treatment group than in placebo patients by 15 to 30 minutes. Total sleep time was significantly longer in zaleplon-treated patients than in placebo patients at week one. Patient questionnaire data supported this general increase in sleep time in with zaleplon. The median total time slept in the sleep laboratory and at home increased over baseline by approximately half an hour for all five weeks in the zaleplon group. The median total time slept for zaleplon patients at home was 12 to 34 minutes longer than that for placebo patients during weeks 1, 2 and five. There were no statistically significant differences in the percentage of time spent in any of the sleep stages for zaleplon patients versus placebo patients at week five. Throughout the study, the time spent awake versus baseline was similar in both groups during the second, third, and fourth quarters of the nights. Zaleplon-treated patients had significantly less waking time in the first quarter of the night than placebo patients, when compared with respective baseline values, for all five weeks. There was no evidence of pharmacologic tolerance nor any indication of rebound insomnia after therapy was discontinued. Zaleplon was also generally well tolerated. Dr. Scharf said zaleplon differs from classic benzodiazepines in that it is a pyrazolopyrimidine hypnotic that binds selectively to the benzodiazepine type I site on the GABA A receptor complex in the brain.
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