Ramelteon: a novel treatment for the treatment of insomnia.

Ramelteon, a potent agonist for the melatonin MT1 and MT2 brain receptors, has recently been granted approval by the US FDA for the treatment of insomnia associated with sleep onset. The drug has not exhibited potential for abuse or dependency in laboratory tests, nor does it interact with neurotransmitter receptors most associated with these phenomena, hence it has the great advantage of being a nonscheduled drug. Few data have been published in peer-reviewed journals describing its efficacy and side effects in patients with insomnia; however, side effects noted to date appear minor. No comparison study has been performed to determine whether the recommended dose of ramelteon 8 mg has any advantage over physiologic doses of melatonin (0.3 mg), particularly for long-term use.