The effects of substituting zopiclone in withdrawal from chronic use of benzodiazepine hypnotics

Twenty-four volunteers (19 women and five men) with insomnia and a history of chronic use of benzodiazepine hypnotics participated in a randomized, do uble blind, controlled clinical trial. The study was designed to assess the effects of substituting zopiclone (ZOP) - as an hypnotic - among chronic u sers of flunitrazepam (FLU), and to compare the subsequent withdrawal of ZO P with placebo controlled withdrawal of FLU. During the 5 weeks of a withdr awal protocol, sleep and physiological parameters were assessed by polysomn ographic measures for 11 nights and by nightly actigraphic recordings for w eeks 1, 3, and 5. Subjective effects of the withdrawal process were evaluat ed with daily sleep diaries, and with various weekly self-report symptom ch ecklists. Paired t-tests performed on differences in objective sleep parame ters between baseline and the last weeks of the withdrawal program showed a significant decrease in sleep quality within the FLU group, but not in the ZOP group. Subjective sleep diaries consistently reflected the objectively measured changes in sleep throughout the withdrawal program, indicating si gnificant changes in sleep parameters only in the FLU group. The results ob tained from the self report inventories aimed at assessing withdrawal sympt oms, however, revealed no differences between the baseline week and the ter mination week of the program in any of the groups. After completing the pha rmacological withdrawal, all subjects received a short-term cognitive behav ioral intervention focused on improving their coping strategies with sympto ms of insomnia; they were evaluated immediately after concluding the interv ention, and at 3 and 12 month follow-ups.