Placebo-controlled clinical trial of Dormicum 15-mg tablet.

Abstract

In 60 insomnia patients placebo-controlled clinical examinations were performed with Dormicum hypnotic containing 15 mg midazolam active substance and made available by EGIS Pharmaceuticals. The patients involved in the study lived a normal life and belonged to both sexes. In the introduction the author summarizes the different forms of pathological sleep and discusses the pharmacology of some hypnotics on the basis of which a detailed, multifactorial, up-to-date clinical examination of a hypnotic should be planned. He uses up-to-date methods and means for the examination of the drug which meet the requirements of an adequate clinical testing of a hypnotic. The sleep disturbances of the patients have been classified and characterized by the author from the somnological aspects and with somnological methods. Patients with sleep onset, sleep maintenance, early morning, as well as mixed insomnias were differentiated. The effectivity of the drug was evaluated on the basis of data of sleep questionnaires referring to the target symptoms and the results of 24-hour polygraphic monitorings performed in 18 patients. In addition, the eventual hangover effect of the drug was assessed in these patients on the basis of the changes in reaction time, pulse rate, and skin resistance measured by polygraphy, besides placebo control on the day following the intake of the drug. The neurological and other organic side-effects were also examined and registered by means of the self-evaluating questionnaires, target specific interviewing of the patients, as well as by laboratory examinations. The drug proved to be most valuable as a hypnotic in patients with sleep onset and mixed insomnias. The hypnotic action was not so definite in sleep maintenance insomnias, the poorest responses were obtained in early morning insomnia cases. According to the results of polygraphic sleep examinations the two first sleep cycles become normal following the intake of the hypnotic. Parameters characteristic of REM sleep do not show changes. In the examined patients the number of side- and hangover effects attributable to the drug was very low. The author calls the attention to the importance of the observance of the dosage and administration of the drug which may prevent the development of a great number of side-effects. By giving a detailed description of a case history of an insomniac patient the author illustrates how the application field of midazolam may be further extended--within the frames of a sleep therapeutic process.