Efficacy and tolerability of ramelteon in a double-blind, placebo-controlled, crossover study in Japanese patients with chronic primary insomnia
| Autor: | Mitsukuni Murasaki, Masako Kohsaka, Kunihisa Kamikawa, Takashi Kanemura, Hiroo Kuwahara, Yoshiro Sugita, Hideki Uno, Mitsutaka Taniguchi, Atsushi Ogawa, Akira Mikami |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Polysomnography Ramelteon Placebo Drug Administration Schedule law.invention Young Adult Asian People Double-Blind Method Randomized controlled trial law Sleep Initiation and Maintenance Disorders Surveys and Questionnaires Insomnia medicine Humans Hypnotics and Sedatives Pharmacology (medical) Cross-Over Studies Dose-Response Relationship Drug medicine.diagnostic_test General Neuroscience Middle Aged Crossover study Treatment Outcome Indenes Tolerability Anesthesia Female Sleep Stages Neurology (clinical) medicine.symptom Sleep Psychology Somnolence medicine.drug |
| Zdroj: | Expert Review of Neurotherapeutics. 11:1389-1397 |
| ISSN: | 1744-8360 1473-7175 |
| Popis: | The aim of this study was to evaluate the efficacy and safety of ramelteon 4, 8, 16 or 32 mg and placebo in Japanese patients with chronic insomnia using a randomized, double-blind, five-period crossover design. A total of 65 Japanese patients with chronic primary insomnia received ramelteon or placebo for two nights each in sleep laboratories. Changes in sleep parameters were assessed objectively by polysomnography and subjectively by postsleep questionnaires. Safety and tolerability was evaluated by assessment of the occurrence of adverse events, next-day residual effects and laboratory and ECG investigations. Ramelteon 8 and 32 mg significantly shortened the mean latency to persistent sleep in comparison with placebo, and there was a statistically significant trend for linear dose-response for this sleep parameter. Overall changes in sleep architecture were modest ( |
| Databáze: | OpenAIRE |
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