A multi-centre, double-blind trial in general practice comparing the hypnotic efficacy and event profiles of flunitrazepam and temazepam. 1985

R J Fisher, and B C Dean

Two hundred and ninety-nine patients requiring treatment for a sleep disturbance were recruited into a double-blind multi-centre trial by 47 doctors. Patients received either 1 mg flunitrazepam or 20 mg temazepam for from 7 to 14 days. Analysis of the results of assessment in 246 patients by doctors and patients indicated that flunitrazepam was significantly better than temazepam in the improvement of onset of sleep, reduction in nocturnal awakenings and early morning awakenings. The solicited event profiles of both treatments were similar and consistent with the low risk expected of a hypnotic.

UI MeSH Term Description Entries
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
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
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
D005445 Flunitrazepam A benzodiazepine with pharmacologic actions similar to those of DIAZEPAM that can cause ANTEROGRADE AMNESIA. Some reports indicate that it is used as a date rape drug and suggest that it may precipitate violent behavior. The United States Government has banned the importation of this drug. Fluridrazepam,Rohypnol,Fluni 1A Pharma,Flunibeta,Flunimerck,Fluninoc,Flunitrazepam-Neuraxpharm,Flunitrazepam-Ratiopharm,Flunitrazepam-Teva,Flunizep Von Ct,Narcozep,RO-5-4200,Rohipnol,Flunitrazepam Neuraxpharm,Flunitrazepam Ratiopharm,Flunitrazepam Teva,RO54200,Von Ct, Flunizep
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012893 Sleep Wake Disorders Abnormal sleep-wake schedule or pattern associated with the CIRCADIAN RHYTHM which affect the length, timing, and/or rigidity of the sleep-wake cycle relative to the day-night cycle. Sleep Disorders,Long Sleeper Syndrome,Short Sleep Phenotype,Short Sleeper Syndrome,Sleep-Related Neurogenic Tachypnea,Subwakefullness Syndrome,Disorder, Sleep,Disorder, Sleep Wake,Disorders, Sleep,Disorders, Sleep Wake,Long Sleeper Syndromes,Neurogenic Tachypnea, Sleep-Related,Neurogenic Tachypneas, Sleep-Related,Phenotype, Short Sleep,Phenotypes, Short Sleep,Short Sleep Phenotypes,Short Sleeper Syndromes,Sleep Disorder,Sleep Phenotypes, Short,Sleep Related Neurogenic Tachypnea,Sleep Wake Disorder,Sleep-Related Neurogenic Tachypneas,Sleeper Syndrome, Long,Sleeper Syndrome, Short,Sleeper Syndromes, Long,Sleeper Syndromes, Short,Subwakefullness Syndromes,Syndrome, Long Sleeper,Syndrome, Short Sleeper,Syndrome, Subwakefullness,Syndromes, Long Sleeper,Syndromes, Short Sleeper,Syndromes, Subwakefullness,Tachypnea, Sleep-Related Neurogenic,Tachypneas, Sleep-Related Neurogenic,Wake Disorder, Sleep,Wake Disorders, Sleep
D013693 Temazepam A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent. Hydroxydiazepam,Methyloxazepam,Norkotral Tema,3-Hydroxydiazepam,Apo-Temazepam,Dasuen,Euhypnos,Gen-Temazepam,Levanxol,Nocturne,Normison,Normitab,Nortem,Novo-Temazepam,Nu-Temazepam,Oxydiazepam,PMS-Temazepam,Planum,Pronervon T,Remestan,Restoril,Ro-5-5345,SaH 47-603,Signopam,Temaze,Temazep Von Ct,Temtabs,Tenox,WY-3917,3 Hydroxydiazepam,Apo Temazepam,Gen Temazepam,Novo Temazepam,Nu Temazepam,PMS Temazepam,Ro 5 5345,Ro55345,SaH 47 603,SaH 47603,Tema, Norkotral,Von Ct, Temazep,WY 3917,WY3917
D014151 Anti-Anxiety Agents Agents that alleviate ANXIETY, tension, and ANXIETY DISORDERS, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions. ADRENERGIC BETA-ANTAGONISTS are commonly used in the symptomatic treatment of anxiety but are not included here. Anti-Anxiety Agent,Anti-Anxiety Drug,Anxiolytic,Anxiolytic Agent,Anxiolytic Agents,Tranquilizing Agents, Minor,Anti-Anxiety Drugs,Anti-Anxiety Effect,Anti-Anxiety Effects,Antianxiety Effect,Antianxiety Effects,Anxiolytic Effect,Anxiolytic Effects,Anxiolytics,Tranquillizing Agents, Minor,Agent, Anti-Anxiety,Agent, Anxiolytic,Agents, Anti-Anxiety,Agents, Anxiolytic,Agents, Minor Tranquilizing,Agents, Minor Tranquillizing,Anti Anxiety Agent,Anti Anxiety Agents,Anti Anxiety Drug,Anti Anxiety Drugs,Anti Anxiety Effect,Anti Anxiety Effects,Drug, Anti-Anxiety,Drugs, Anti-Anxiety,Effect, Anti-Anxiety,Effect, Antianxiety,Effect, Anxiolytic,Effects, Anti-Anxiety,Effects, Antianxiety,Effects, Anxiolytic,Minor Tranquilizing Agents,Minor Tranquillizing Agents

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