Critical appraisal of ramelteon in the treatment of insomnia

Monique AJ Mets, Kenny R van Deventer, Berend Olivier, Joris C Verster
Utrecht University, Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacology, Utrecht, The Netherlands

Abstract: Ramelteon is the first member of a novel class of hypnotics and acts as a selective melatonin receptor agonist. In 2005, ramelteon was approved by the US Food and Drug Administration for the treatment of insomnia characterized by sleep onset problems. Its unique mechanism of action made it a promising candidate compared with the widely used hypnotics that act on the benzodiazepine receptor complex. Several studies have examined its efficacy and safety as a hypnotic agent. The primary efficacy of ramelteon was found to lie in a decrease in latency to persistent sleep, as measured by polysomnographic tests. Other sleep-related measures, such as total sleep time and number of nightly awakenings, show less pronounced improvement when treated with ramelteon. In addition, no rebound insomnia or abuse potential was observed in clinical studies. Although additional studies are necessary, current data on the acute and next-morning effects of ramelteon did not indicate cognitive or psychomotor impairment. Overall, ramelteon is safe and well tolerated, although some questions remain regarding its long-term efficacy and safety. These issues and possibilities for use in other patient groups should be addressed in future research.

Keywords: ramelteon, melatonin, insomnia, hypnotics