Double-blind study on the hypnotic and antianxiety effects of zopiclone compared with nitrazepam in the treatment of insomnia

Int J Clin Pharmacol Res. 1989;9(4):277-81.


The effects of zopiclone (7.5 mg/per os/day), a new non-benzodiazepine drug, on anxiety levels, time of sleep induction, hours of sleep, number of nocturnal arousals, quality of sleep and of daytime arousal were evaluated by using psychometric ratings. A random double-blind cross-over study versus nitrazepam (5.0 mg/per os/day) was performed on 20 patients affected by insomnia and generalized anxiety disorder (DSM III-R). The effects were evaluated by using the Hamilton Rating Scale for Anxiety, the Toulouse-Pieron Attention Test and a time-signed quantitative scale for anxiety. The results of the trial confirmed the effectiveness of zopiclone in the treatment of insomnia with effects similar to nitrazepam on the quality and duration of sleep and number of nocturnal arousals, but with an improvement in all the other parameters.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Anxiety Disorders / complications
  • Anxiety Disorders / drug therapy
  • Azabicyclo Compounds
  • Chronic Disease
  • Clinical Trials as Topic
  • Double-Blind Method
  • Female
  • Humans
  • Hypnotics and Sedatives / pharmacology*
  • Male
  • Nitrazepam / pharmacology*
  • Piperazines / pharmacology*
  • Random Allocation
  • Sleep Initiation and Maintenance Disorders / complications
  • Sleep Initiation and Maintenance Disorders / drug therapy*
  • Time Factors


  • Azabicyclo Compounds
  • Hypnotics and Sedatives
  • Piperazines
  • zopiclone
  • Nitrazepam