Comparative clinical studies with midazolam, oxazepam and placebo. 1983

C Feldmeier, and W Kapp

The efficacy and safety of midazolam compared with oxazepam and placebo were investigated in 50 hospital patients (19 males, 31 females; age range 21 to 74 years) in a double-blind parallel group study. On the first 2 nights (selection phase), patients received only placebo. On the next 5 nights, they received either 15 mg midazolam, 15 mg oxazepam or placebo. They received no medication on the last 2 nights and were kept under observation (withdrawal phase). Compared with placebo, both benzodiazepines shortened sleep onset latency, reduced the number of awakenings and improved sleep quality. All 3 compounds were well tolerated with only few, mild side-effects (headache, nausea) in the 2 verum groups. Psychometric performance was not impaired on the morning following drug administration. The overall patients' assessments showed 80% satisfaction with midazolam, 66% with oxazepam and 10% with placebo. Midazolam and oxazepam yielded similar results, although midazolam induced sleep more rapidly and was rated more favourably by the patients. Midazolam, in a dose of 15 mg, is thus an effective, fast-acting, well-tolerated hypnotic without residual effects and is suitable for the treatment of insomnia of mild to moderate degree. Oxazepam in a dose of 15 mg is also well suited for the treatment of sleep disorders, particularly if a rapid onset of action is not required.

UI MeSH Term Description Entries
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
D008297 Male Males
D008874 Midazolam A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH. Dormicum,Midazolam Hydrochloride,Midazolam Maleate,Ro 21-3981,Versed,Hydrochloride, Midazolam,Maleate, Midazolam,Ro 21 3981,Ro 213981
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010076 Oxazepam A benzodiazepine used in the treatment of anxiety, alcohol withdrawal, and insomnia. Adumbran,Serax,Tazepam
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
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
D004325 Dreams A series of thoughts, images, or emotions occurring during sleep which are dissociated from the usual stream of consciousness of the waking state. Nightmares,Dream,Nightmare
D005260 Female Females

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