[Controlled clinical study on the effect of quazepam versus triazolam in patients with sleep disorders].
Quazepam (QZP), a new long half-life benzodiazepine, seems to have a more specific hypnotic activity and a "physiological" mechanism of action. This study assessed its clinical efficacy and any withdrawal symptoms occurring after the treatment with QZP and triazolam (TRZ). Sixty-five patients (mean age 41.4 yrs +/- 12.43 SD) with sleep disorders were included in the study. The patients were treated with placebo for 4 days (run-in period) and if no amelioration of insomnia was observed, were then randomly allocated to 15 mg QZP (33 patients) or TRZ (32 patients) for 8 weeks and finally placebo for another week. Sleep quality, efficiency, side-effects and withdrawal effects were assessed by specific rating scales. In comparing data obtained from the two treatments, the following conclusions were drawn: 1) both drugs showed a hypnoinductive efficacy but patients treated with QZP had significantly fewer night awakenings; 2) at the end of treatment only patients treated with TRZ had longer awakenings and rebound symptoms; 3) a lower withdrawal symptom incidence was observed in patients treated with QZP. Therefore, QZP seems to have a good hypnotic effect without inducing withdrawal symptoms. In contrast TRZ turned out to be a merely hypno-inducing drug presenting higher risks of rebound effects after withdrawal.
Altamura
A C
AC
Colacurcio
F
F
Mauri
M C
MC
De Vanna
M
M
Rigamonti
R
R
Maj
M
M
Veltro
F
F
Pancheri
P
P
Delle Chiaie
R
R
Porta
M
M
D000293:Adolescent; D000328:Adult; D014151:Anti-Anxiety Agents; D001569:Benzodiazepines / Q000627:therapeutic use*; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D014229:Triazolam / Q000627:therapeutic use*
D014151:Anti-Anxiety Agents; D001569:Benzodiazepines; D014229:Triazolam; C025130:quazepam
Studio clinico controllato dell'effetto del quazepam vs triazolam in pazienti con disturbi del sonno.