A randomized clinical trial comparing doses and efficacy of lormetazepam tablets or oral solution for insomnia in a general practice setting.
Lormetazepam is a short-acting benzodiazepine hypnotic which is beneficial in shortening the time to onset of sleep. The aim of the study was to assess a new formulation of lormetazepam (oral solution) in comparison with lormetazepam tablets in out-patients with insomnia. This trial was an open randomized parallel group study conducted by 30 general practitioners. One hundred and eight patients took 0.5 mg on the first night and were allowed to increase their dosage by 0.25 mg (for oral solution) and 0.5 mg (for tablets), respectively, each day and every 2 days. The patients assessed the efficacy, acceptability and tolerance of lormetazepam using a diary card and a set of visual analogue scales assessing their sleep. Over 14 days of treatment, the mean daily dose of lormetazepam was lower in the oral solution group than in the tablets group (0.78 mg versus 0.97 mg). The cumulated dose of lormetazepam was lower with the oral solution (18% reduction). No significant difference between the two groups was found in the assessment of sleep characteristics. The occurrence of side effects did not differ between the two groups. These results suggest that a unitary dose as achieved by an oral solution of lormetazepam allows easier determination of the minimal individual effective dose.
CPCET et Pharmacologie Clinique, Institut des Neurosciences Physiologiques et Cognitives, Faculté de Médecine, FRE 2109 CNRS-Université de la Méditerranée, Assistance Publique Hôpitaux de Marseille-Hôpital de la Timone, 13385 Marseille Cedex 5, France.
C
C
Ancolio
S
S
Tardieu
C
C
Soubrouillard
C
C
Alquier
V
V
Pradel
J
J
Micallef
O
O
Blin
D000284:Administration, Oral; D000328:Adult; D000704:Analysis of Variance; D005194:Family Practice / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008140:Lorazepam / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D019999:Pharmaceutical Solutions; D007319:Sleep Initiation and Maintenance Disorders / Q000188:drug therapy* / Q000503:physiopathology; D013607:Tablets
D019999:Pharmaceutical Solutions; D013607:Tablets; C023842:lormetazepam; D008140:Lorazepam