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| Research article summary (published 30 Jan 2002): |
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Noise-induced sleep maintenance insomnia: hypnotic and residual effects of zaleplon.
Full Abstract
AIMS:
The primary objective of the study was to assess the residual effects of zaleplon in the morning, 4 h after a middle-of-the-night administration. The secondary objective was to investigate the effectiveness of zaleplon in promoting sleep in healthy volunteers with noise-induced sleep maintenance insomnia.
METHODS:
Thirteen healthy male and female volunteers (aged 20-30 years) with normal hearing, who were sensitive to the sleep-disrupting effects of noise, participated in a double-blind, placebo- and active-drug controlled, four-period cross-over study. The subjects were permitted to sleep for 5 h (22.45-03.45 h) in a quiet environment before they were awoken. At 04.00 h they ingested 10 mg zaleplon, 20 mg zaleplon, 7.5 mg zopiclone (active control), or placebo before a second period of sleep (04.00-08.00 h), during which they were exposed to an 80 dB(A) 1 kHz pure tone pulse with an inter-tone interval of 1 s and a duration of 50 ms. The sound stimulus was stopped after 10 min of persistent sleep or after 2 h if the subject had not fallen asleep. Residual effects were assessed at 08.00 h (4 h after drug administration) using the digit symbol substitution test (DSST), choice reaction time (CRT), critical flicker fusion (CFF), and immediate and delayed free recall of a 20 word list. The data were analysed by analysis of variance. A Bonferroni adjustment was made for the three active treatments compared with placebo.
RESULTS:
There were no residual effects of zaleplon (10 and 20 mg) compared with placebo. Zopiclone impaired memory by delaying the free recall of words (P = 0.001) and attenuated performance on DSST (P = 0.004) and CRT (P = 0.001), compared with placebo. Zaleplon reduced the latency to persistent sleep (10 mg, P = 0.001; 20 mg, P = 0.014) and the 20 mg dose reduced stage 1 sleep (P = 0.012) compared with placebo. Zopiclone reduced stage 1 sleep (P = 0.001), increased stage 3 sleep (P = 0.0001) and increased total sleep time (P = 0.003), compared with placebo.
CONCLUSIONS:
Zaleplon (10 mg and 20 mg), administered in the middle of the night 4 h before arising, shortens sleep onset without impairing next-day performance.
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Author information
Author/s: Stone, Barbara M (BM); Turner, Claire (C); Mills, Sue L (SL); Paty, Isabelle (I); Patat, Alain (A); Darwish, Mona (M); Danjou, Philippe (P);
Affiliation: QinetiQ Ltd, Centre for Human Sciences, Farnborough, Hampshire, GU14 0LX, UK. bmstone(-atsign-)QinetiQ.com
Journal and publication information
Publication Type: Clinical Trial; Controlled Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
Journal: British journal of clinical pharmacology (Br J Clin Pharmacol), published in England. (Language: eng)
Reference: 2002-Feb; vol 53 (issue 2) : pp 196-202
Dates: Created 2002/02/19; Completed 2002/04/19; Revised 2007/11/15;
PMID: 11851645, status: MEDLINE (last retrieval date: 11/6/2008)
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
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