A comparative study of the clinical effects of oral flunitrazepam, medazepam, and placebo.
In a double-blind randomized study 40 patients received 1 mg flunitrazepam, 40 patients received 10 mg medazepam, and 40 patients received placebo p.o. the night before surgery. On the morning of surgery each patient received another identical oral dose of the product or placebo taken the previous night. On the average, the flunitrazepam group slept better, was better sedated, and was less anxious than the medazepam or placebo groups. Similarly, as a reflection of diminished autonomic reactions, the patients receiving flunitrazepam had fewer cardiovascular changes. Flunitrazepam significantly decreased the amounts of thiopentone needed for induction of anesthesia. Medazepam did not. The pronounced sedative, sleep-inducing, and anxiolytic effects of flunitrazepam appear to be of great clinical importance for its use in anesthesiology. Repeated administrations of medazepam seem to be required to produce an evident clinical effect of the drug, possibly via the slow accumulation of metabolites. The main difference between these two benzodiazepine derivatives as regards clinical response therefore seems to be pharmacokinetic in origin.
D000328:Adult; D014151:Anti-Anxiety Agents / Q000494:pharmacology*; D004311:Double-Blind Method; D005445:Flunitrazepam / Q000009:adverse effects / Q000494:pharmacology*; D006207:Half-Life; D006439:Hemodynamics / Q000187:drug effects; D006801:Humans; D008472:Medazepam / Q000009:adverse effects / Q000494:pharmacology*; D011300:Preoperative Care; D011897:Random Allocation
D014151:Anti-Anxiety Agents; D005445:Flunitrazepam; D008472:Medazepam