[Treatment of insomnia related to depressive disorders. Effects of zolpidem versus flunitrazepam administration and withdrawal evaluated in a double-blind study].

The effects of a 15 day treatment with zolpidem (10 mg) and with flunitrazepam (1 mg) on Insomnia Disorders Related to Depressive Disorders (DSM-III-R) have been evaluated on 30 depressive in-patients (mean age 42.3 +/- 9.8). The trial has been carried out on double blind condition after 5 days of single blind placebo administration. Withdrawal effects have been evaluated in single blind condition on a 10 day period after drugs discontinuation. Patient's diagnosis was Major Depression or Dysthymia according to DSM-III-R; inclusion criteria were insomnia (total sleep time < or = 6 h, sleep latency > or = 30 min, wake after sleep onset > or = 30 min, No of awakenings > or = 3) refractory to clomipramine administration at constant dose (75-150 mg/day among patients). Both drugs have been followed by a rapid, significant diminution of insomnia as demonstrated by significant changes at Stanford Sleepiness Scale and Saint Mary Hospital Sleep Questionnaire and by a significant reduction of HDRS total scores. No clinical phenomena of rebound insomnia were detected after zolpidem and flunitrazepam withdrawal. Drug discontinuation however was followed by the slow increase of the score on insomnia items, approximating basal values at the end of the 10 day period after zolpidem and flunitrazepam withdrawal. A parallel increase of HDRS total score was also detected; HDRS changes were mainly due to the increase of the items anxiety somatic, general somatic symptoms, gastrointestinal somatic symptoms, hypochondriasis. The study confirms the therapeutic efficacy of zolpidem and of flunitrazepam in the treatment of insomnia resistant to antidepressant drugs in depressed patients. They also suggest that early drug discontinuation is frequently associated with clinical relapse of insomnia and of several other symptoms correlated with the affective pathology.