A comparison of efficacy and tolerance of the short acting sedatives midazolam and zopiclone.
OBJECTIVE
To compare the efficacy and tolerance of midazolam, 15 mg and zopiclone 7.5 mg once daily for seven days in a prospective, double blind trial of 88 patients, aged 18 or over, with sleep disorders in general practice.


METHODS
Efficacy was evaluated using the Leeds sleep evaluation questionnaire (LSEQ). Adverse reactions were recorded as volunteered.


RESULTS
fifty-one patients completed all aspects of the trial without violation of the protocol. Patients taking zopiclone improved in all aspects of the Leeds questionnaire (p < 0.01). Patients taking midazolam improved in six out of 10 items (p < 0.01). Rebound insomnia was evident in the zopiclone group in five out of 10 items of the LSEQ. Rebound was not evident in the midazolam group. There were no significant differences between midazolam 15 mg, and zopiclone 7.5 mg, in comparison between groups. Thirty-eight patients suffered 49 adverse drug reactions and there were no differences between the groups.


CONCLUSIONS
Zopiclone 7.5 mg daily improved more items on the LSEQ than midazolam 15 mg daily but was associated with significant rebound insomnia. Adverse reactions were frequent with both drugs.
Begg
E J
EJ
Department of Clinical Pharmacology, Christchurch Hospital.
Robson
R A
RA
Frampton
C M
CM
Campbell
J E
JE
D000293:Adolescent; D000328:Adult; D053961:Azabicyclo Compounds; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008874:Midazolam / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D016896:Treatment Outcome
D053961:Azabicyclo Compounds; D006993:Hypnotics and Sedatives; D010879:Piperazines; C515050:zopiclone; D008874:Midazolam