Clinical and psychometric evaluation of two doses of loprazolam and placebo in geriatric patients. 1986

A J Bayer, and M S Pathy

A double-blind, parallel group, randomized trial was carried out to compare the hypnotic efficacy, tolerance and psychometric effects of two doses of loprazolam and placebo in 89 elderly hospital in-patients. All had disturbed sleep patterns, which were not the result of serious psychiatric or physical illness and, after a 1 or 2 day single-blind placebo baseline period, they received either 0.5 mg or 1.0 mg loprazolam or placebo administered double-blind for 5 days. The sleep of patients in all three treatment groups, as measured by patient self-rating scales, substantially improved during the study, with loprazolam being superior to placebo for measures of sleep latency, satisfaction with sleep, number of nocturnal awakenings and feeling refreshed on waking. Differences in hypnotic efficacy between the 0.5 mg and 1.0 mg loprazolam groups were not significant. The incidence of side-effects was low and, although there was a significant relationship with loprazolam treatment, this was not dose-related. Performance tests for residual effects (critical flicker fusion threshold and choice reaction time) showed no difference between the placebo and active treatment groups, suggesting that loprazolam, even in a dose of 1.0 mg, is unlikely to produce hangover effects. It is concluded that the findings confirm that loprazolam is an effective and well-tolerated hypnotic in the elderly and that a 0.5 mg dose would be an appropriate initial dose for older patients.

UI MeSH Term Description Entries
D006993 Hypnotics and Sedatives Drugs used to induce drowsiness or sleep or to reduce psychological excitement or anxiety. Hypnotic,Sedative,Sedative and Hypnotic,Sedatives,Hypnotic Effect,Hypnotic Effects,Hypnotics,Sedative Effect,Sedative Effects,Sedatives and Hypnotics,Effect, Hypnotic,Effect, Sedative,Effects, Hypnotic,Effects, Sedative,Hypnotic and Sedative
D008297 Male Males
D010352 Patient Dropouts Discontinuance of care received by patient(s) due to reasons other than full recovery from the disease. Dropout, Patient,Dropouts, Patient,Patient Dropout
D010919 Placebos Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. Sham Treatment
D011897 Random Allocation A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects. Randomization,Allocation, Random
D011930 Reaction Time The time from the onset of a stimulus until a response is observed. Response Latency,Response Speed,Response Time,Latency, Response,Reaction Times,Response Latencies,Response Times,Speed, Response,Speeds, Response
D002755 Choice Behavior The act of making a selection among two or more alternatives, usually after a period of deliberation. Approach Behavior,Approach Behaviors,Behavior, Approach,Behavior, Choice,Behaviors, Approach,Behaviors, Choice,Choice Behaviors
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004341 Drug Evaluation Any process by which toxicity, metabolism, absorption, elimination, preferred route of administration, safe dosage range, etc., for a drug or group of drugs is determined through clinical assessment in humans or veterinary animals. Evaluation Studies, Drug,Drug Evaluation Studies,Drug Evaluation Study,Drug Evaluations,Evaluation Study, Drug,Evaluation, Drug,Evaluations, Drug,Studies, Drug Evaluation,Study, Drug Evaluation
D005260 Female Females

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