A new design of trial for hypnotics comparison: a double-blind cross-over trial with patient's preference assessment and continuation of the preferred treatment.
1. This study compared two hypnotics administrated at comparable therapeutic dosages: triazolam (0.25 mg) and loprazolam (1 mg), were administered using an original scheme (cross-over on the first 2 nights, and continuation of the preferred treatment or new randomization). 2. Sixty-seven outpatients complaining of common insomnia participated in this study conducted by general practitioners. 3. Both drugs provided improvement in sleep quality (decreased sleep latency, increased total duration of sleep, decreased number of night awakenings), and are equally well tolerated. 4. For the first 2 nights, triazolam was evaluated to be more efficient than loprazolam (p < 0.001), and patients felt more rested the following day (p < 0.01) with the former drug. Moreover, triazolam is more frequently preferred than loprazolam by 47.7% and 29.2%, respectively, (p = 0.09). 5. No interaction was found between treatment and order of administration or specific effects and order of administration.
Bourin
M
M
GIS Médicament, Faculté de Médecine, Nantes, France.
Malinge
M
M
D000328:Adult; D014151:Anti-Anxiety Agents / Q000627:therapeutic use*; D001569:Benzodiazepines; D001570:Benzodiazepinones / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy*; D014229:Triazolam / Q000627:therapeutic use*
D014151:Anti-Anxiety Agents; D001570:Benzodiazepinones; D001569:Benzodiazepines; D014229:Triazolam; C020168:triazulenone