Double blind comparison of zolpidem 20 mg versus flunitrazepam 2 mg in insomniac in-patients. 1990

L Frattola, and M Maggioni, and B Cesana, and P Priore
V Neurological Department, University of Milan, Italy.

The efficacy of zolpidem 20 mg was compared to that of flunitrazepam 2 mg. Forty-two insomniac female in-patients between 30 and 65 years of age were included in a double blind, parallel group trial and were randomly allocated to the two treatments. Study duration was 9 days with 2 days of placebo run-in, 5 days of active medication and 2 days of placebo withdrawal. Sleep latency, sleep duration, number of awakenings and time spent asleep during the night were given an ordinal score; condition in the morning was evaluated by Visual Analogue Scales and the psychomotor performance was evaluated by the tests: night-day for anterograde amnesia, digit span for verbal recall and Grünberger's fine motor function test. There was no significant difference between zolpidem and flunitrazepam for any of the variables; the drugs were significantly better than placebo baseline for all the sleep efficacy variables. The results of this study indicate that zolpidem is as effective as flunitrazepam in inducing and maintaining sleep but it does not induce a sense of weakness in the morning and does not impair memory.

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
D007319 Sleep Initiation and Maintenance Disorders Disorders characterized by impairment of the ability to initiate or maintain sleep. This may occur as a primary disorder or in association with another medical or psychiatric condition. Disorders of Initiating and Maintaining Sleep,Insomnia,Sleeplessness,Chronic Insomnia,DIMS (Disorders of Initiating and Maintaining Sleep),Early Awakening,Insomnia Disorder,Nonorganic Insomnia,Primary Insomnia,Psychophysiological Insomnia,Rebound Insomnia,Secondary Insomnia,Sleep Initiation Dysfunction,Transient Insomnia,Awakening, Early,Dysfunction, Sleep Initiation,Dysfunctions, Sleep Initiation,Insomnia Disorders,Insomnia, Chronic,Insomnia, Nonorganic,Insomnia, Primary,Insomnia, Psychophysiological,Insomnia, Rebound,Insomnia, Secondary,Insomnia, Transient,Insomnias,Sleep Initiation Dysfunctions
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D011725 Pyridines Compounds with a six membered aromatic ring containing NITROGEN. The saturated version is PIPERIDINES.
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
D005260 Female Females
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
D000077334 Zolpidem An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA. Imidazo(1,2-a)pyridine-3-acetamide, N,N,6-trimethyl-2-(4-methylphenyl)-,Ambien,Amsic,Bikalm,Dalparan,N,N,6-Trimethyl-2-(4-methylphenyl)imidazo(1,2a)pyridine-3-acetamide hemitartrate,SL 80.0750,SL-800750-23-N,Stilnoct,Stilnox,Zodormdura,Zoldem,Zolirin,Zolpi-Lich,Zolpidem 1A Pharma,Zolpidem AbZ,Zolpidem Hemitartrate,Zolpidem Tartrate,Zolpimist,Zolpinox,SL 800750 23 N,Zolpi Lich
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults

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