Pharmacotherapy of Insomnia with Ramelteon: Safety, Efficacy and Clinical Applications

Journal of Central Nervous System Disease

Review

D. Warren Spence¹  Daniel P. Cardinali²  Gregory M. Brown³  Rüdiger Hardeland⁴  Seithikurippu R. Pandi-Perumal⁵  Venkatramanujam Srinivasan⁶  Joris C. Verster⁷ 

[1] 323 Brock Avenue, Toronto, Ontario M6K 2M6, Canada.;Departamento de Docencia e InvestigacióAn, Facultad de Ciencias MéAdicas, Pontificia Universidad CatóAlica Argentina, C1107AFD Buenos Aires, Argentina.; Departamento de FisiologíAa, Facultad de Medicina, Universidad de Buenos Aires, 1121, Buenos Aires, Argentina.;Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.; Centre for Addiction and Mental Health, 250 College St., Toronto, ON, M5T 1R8, Canada.;Institute of Zoology and Anthropology, University of Goettingen, Berliner Str. 28, D-37073 Goettingen, Germany.;Somnogen Inc, College Street, Toronto, ON M6H 1C5, Canada.;Sri Sathya Sai Medical Educational and Research Foundation, Prasanthi Nilayam, 40-kovai Thirunagar, Coimbatore-641014, India.;Utrecht University, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacology, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands.;

关键词: circadian rhythms;    hypnotic;    insomnia;    melatonin;    ramelteon;    sleep;   

DOI  :  10.4137/JCNSD.S1611

来源: Sage Journals

【 摘 要 】

Ramelteon is a tricyclic synthetic analog of melatonin that acts specifically on MT1 and MT2 melatonin receptors. Ramelteon is the first melatonin receptor agonist approved by the Food and Drug Administration (FDA) for the treatment of insomnia characterized by sleep onset difficulties. Ramelteon is both a chronobiotic and a hypnotic that has been shown to promote sleep initiation and maintenance in various preclinical and in clinical trials. The efficacy and safety of ramelteon in patients with chronic insomnia was initially confirmed in short-term placebo-controlled trials. These showed little evidence of next-day residual effects, withdrawal symptoms or rebound insomnia. Other studies indicated that ramelteon lacked abuse potential and had a minimal risk of producing dependence or adverse effects on cognitive or psychomotor performance. A 6-month placebo-controlled international study and a 1-year open-label study in the USA demonstrated that ramelteon was effective and well tolerated. Other potential off-label uses of ramelteon include circadian rhythm sleep disorders such as shift-work and jet lag. At the present time the drug should be cautiously prescribed for short-term treatment only.

【 授权许可】

CC BY-NC   
© 2011 SAGE Publications.

【 图 表 】

Figure 6.