ZOPICLONE IMPROVES SLEEP QUALITY AND DAYTIME WELL-BEING IN INSOMNIAC PATIENTS - COMPARISON WITH TRIAZOLAM, FLUNITRAZEPAM AND PLACEBO

In a randomized, double-blind, parallel group study in private practic e, zopiclone given for 28 days was compared with flunitrazepam, triazo lam and placebo in its effect on quality of sleep and daytime well-bei ng in 1507 patients suffering from insomnia. For quantitative assessme nt, patients were defined as responders according to either a shorteni ng of sleep latency by at least 15 min, or prolongation of total sleep time by at least 20%, or reduction of the number of nocturnal awakeni ngs to three or less and a fresh feeling in the morning, as well as la ck of impairment in daytime well-being as a result of tiredness or anx iety. The responder rate tended to be higher with zopiclone (37.4%) th an with flunitrazepam (30%) and triazolam (32.2%) and was significantl y greater (p = 0.0017) than with placebo (26.8%). Daytime well-being w as particularly responsive to zopiclone and most responsive in severe insomniacs. With the exception of those to triazolam, rates of respons e were most pronounced in patients with insomnia of a short duration ( less than or equal to 1 year) than in those with insomnia of a longer duration (greater than or equal to 1 year). Following discontinuation of treatment, all groups showed a moderate reduction in therapeutic ef fect, but no rebound insomnia occurred.