Ramelteon: a novel hypnotic indicated for the treatment of insomnia.

Ramelteon is a hypnotic with a novel mechanism of action and is the only melatonin agonist currently indicated for the treatment of insomnia. This drug acts at the MT1 and MT2 receptors to promote sleep and exert an effect on circadian rhythms. Unlike traditional hypnotics, ramelteon demonstrates no affinity for any CNS receptors commonly associated with sedation (GABA, dopamine, opiate, serotonin). Perhaps due to this unique mechanism of action, ramelteon has demonstrated a low potential for abuse in clinical trials involving both insomnia patients and individuals with a history of substance abuse. It is the only insomnia therapeutic that is not classified as a scheduled drug by the US Drug Enforcement Agency (DEA). However, it has been shown in multiple studies to demonstrate a moderate, statistically significant improvement in reducing the time to sleep onset in both adult and elderly insomnia patients in studies lasting up to one year. Generally, treatment with ramelteon is well tolerated and produces few adverse effects.