Effects of zopiclone as compared to flurazepam on sleep in women over 40 years of age.

Zopiclone is a new nonbenzodiazepine hypnotic, the recommended dose of which is 7.5 mg. It was compared to flurazepam 30 mg in a sleep laboratory study. 12 women aged 40-60 years, with subjective sleep disorders for at least 2 months, were treated for 13 nights with each drug in a crossover double-blind design. Each active drug period was preceded by 5 days of placebo washout and followed by 35 days of withdrawal (no treatment). A baseline period of 4 nights (without treatment) was obtained before the study itself. The subjects slept in the sleep laboratory during the baseline period, during the last 3 nights on placebo, during the last 3 nights on active drug, and from the 11th to the 13th night after active drug discontinuation. Polygraphic recordings were obtained during each of these nights. The criteria of Kales and Rechtschaffen were used to score the tracings. Both drugs were shown to be effective when compared to placebo. Comparisons between the two periods with active treatment did not show significant differences for sleep onset latency, total sleep time, sleep efficiency index, stage 0, percent REM, number of REM periods, and REM latency. There was a trend towards an increase with zopiclone of the number of awakenings, percent of stage 3, percent of deep sleep, and an increase with flurazepam of the percent of light sleep. A significant difference was only found for percent of stage 2 (increased with flurazepam).

RCT Entities:   Population Interventions Outcomes