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[Effect on vigilance of a single administration of clobazam].

Two groups of 30 outpatients, each with various types of anxiety and sleep-disturbance, were treated with 7-chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4(3H,5H)-dione (Clobazam, Frisium 20) for 28 days. The double-blind, randomized study was designed to find out whether there is a significant difference between the application of the drug in the morning (group A) or at night (group B). The results of 22 patients of group A and 24 of group B could be evaluated. The following tests had been made at the beginning, after 1,2 and 4 weeks of treatment, respectively: 1. Clinical global impression (CGI) of therapeutic effect and side-effects. 2. Symptoms of psychic and somatic anxiety (HAM-A). 3. Sleep (documented by self-rating and investigator). 4. Daytime-drowsiness/dizziness (self-rating scale). 5. Choice reaction time (CRT) tested between 8 and 9 a.m. on the same day once a week. 6. Critical flicker fusion (CFF) tested between 8 and 9 a.m. on the same day once a week. Sleep and daytime-drowsiness/dizziness have been tested daily within the first week. Significant therapeutic improvement could be stated after 4-week treatment by the CGI-test. The CFF-frequency as indicator for vigilance rose to a significantly higher level while the reaction time in the CRT-test was simultaneously reduced. This result was in accordance with earlier studies. Both groups compared with each other, however, did not differ significantly in any of the parameters used. Symptoms of psychic and somatic anxiety have been reduced significantly in both groups after the first, second and fourth week. There was however one remarkable difference between both groups: this refers to the psychic anxiety factor (HAM-A) only. Here the patients of group B (clobazam in the morning) showed better results than the others. This phenomenon may be due to elevated serum levels during daytime. Therefore we recommend in case of predominant psychic anxiety clobazam to be taken in the morning or in divided doses in the morning and in the evening.