Pharmacotherapy of insomnia with ramelteon : safety, efficacy and clinical applications

• Autores: Pandi Perumal, Seithikurippu R.; Spence, David Warren; Verster, Joris C.; Srinivasan, Venkataramanujan; Brown, Gregory M.; Cardinali, Daniel Pedro; Hardeland, Rüdiger
• Año de publicación: 2011
• Idioma: inglés
• Tipo de recurso: artículo
• Fuente: Journal of Central Nervous System Disease. 2011, 3
• Materia: RITMO CIRCADIANO; MELATONINA; RAMELTEON; SUEÑO; INSOMNIO; HIPNOTICOS Y SEDANTES
• Institución: Pontificia Universidad Católica Argentina

Fil: Pandi Perumal, Seithikurippu R. Somnogen Inc; Canadá
Fil: Spence, David Warren. Investigador Independiente; Canadá
Fil: Verster, Joris C. Universidad de Utrecht. Instituto de Ciencias Farmacéuticas de Utrecht. División de Farmacología; Holanda
Fil: Srinivasan, Venkataramanujan. Sri Sathya Sai Medical Educational and Research Foundation; India
Fil: Brown, Gregory M. Universidad de Toronto. Facultad de Medicina. Departamento de Psiquiatría; Canadá
Fil: Brown, Gregory M. Centre for Addiction and Mental Health; Canadá
Fil: Cardinali, Daniel Pedro. Universidad Católica Argentina. Facultad de Ciencias Médicas. Departamento de Docencia e Investigación; Argentina
Fil: Cardinali, Daniel Pedro. Universidad de Buenos Aires. Facultad de Medicina. Departamento de Fisiología; Argentina
Fil: Hardeland, Rüdiger. Universidad de Goettingen. Insituto de Zoología y Antropología; Alemania
Abstract: 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.