Post marketing surveillance of zopiclone: interim analysis on the first 10,000 cases in a clinical study in general practice.
The tolerance of zopiclone, a hypnotic belonging to a new chemical group, the cyclopyrrolones, was studied in a follow-up trial in 23,000 insomniac outpatients treated for 3 weeks. The results from the interim analysis of the first 10,000 cases confirm the efficacy and safety of zopiclone under usual prescribing conditions. The average daily dose of zopiclone was 0.97 +/- 0.21 tablet (7.275 +/- 1.575 mg). The study population included 63.1% of female and 36.9% of male patients; the mean age was 52.3 +/- 16.6 years. 93.1% of the patients completed the trial. 8.2% of the patients experienced adverse reactions which resulted in drug discontinuation in only 2.8% of cases. In the global evaluation, the efficacy was rated excellent or good in more than 80% of the patients.
Département de Pharmacovigilance, Théraplix Groupe, Rhône-Poulenc, France.
C
C
Delahaye
B
B
Ferrand
C
C
Pieddeloup
B
B
Musch
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001143:Arousal / Q000187:drug effects; D053961:Azabicyclo Compounds; D005194:Family Practice; D005260:Female; D005602:France; D006801:Humans; D006993:Hypnotics and Sedatives; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D014851:Wakefulness / Q000187:drug effects
D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; C515050:zopiclone