Ramelteon has been assessed in only a few studies in the treatment of circadian rhythm sleep disorders, including jet lag disorder, shift work disorder, and non-24-hour sleep–wake disorder. These studies have been of varying quality and their findings in terms of effectiveness have been mixed. Ramelteon is approved only for treatment of insomnia and is not approved for treatment of circadian rhythm sleep disorders. It was previously under development for treatment of circadian rhythm sleep disorders, but development for these indications was discontinued. Other uses
Delirium
A systematic review, published in 2014, concluded "ramelteon was found to be beneficial in preventing delirium in medically ill individuals when compared to placebo." A 2022 systematic review and meta-analysis found that the combination of ramelteon and the orexin receptor antagonist suvorexant may reduce the incidence of delirium in adults hospitalized patients whereas suvorexant alone was ineffective. Bipolar disorder
Ramelteon has received attention in psychiatry as a possible add-on treatment for mania in bipolar disorder. However, to date, the scarce available evidence fails to support the clinical utility of ramelteon and other melatonin receptor agonists such as melatonin for mania. Available forms
Ramelteon is available in the form of 8 mg oral film-coated tablets. Contraindications
Ramelteon is not recommended for use in people with severe sleep apnea. Adverse effects
Side effects of ramelteon include somnolence (3% vs. 2% for placebo), fatigue (3% vs. 2% for placebo), dizziness (4% vs. 3% for placebo), nausea (3% vs. 2% for placebo), and exacerbated insomnia (3% vs. 2% for placebo).
Ramelteon, sold under the brand name Rozerem among others, is a melatonin agonist medication which is used in the treatment of insomnia. It is indicated specifically for the treatment of insomnia characterized by difficulties with sleep onset. It reduces the time taken to fall asleep, but the degree of clinical benefit is small. The medication is approved for long-term use. Ramelteon is taken by mouth.Side effects of ramelteon include somnolence, dizziness, fatigue, nausea, exacerbated insomnia, and changes in hormone levels. Ramelteon is an analogue of melatonin and is a selective agonist of the melatonin MT1 and MT2 receptors. The half-life and duration of ramelteon are much longer than those of melatonin. Ramelteon is not a benzodiazepine or Z-drug and does not interact with GABA receptors, instead having a distinct mechanism of action.Ramelteon was first described in 2002 and was approved for medical use in 2005. Unlike certain other sleep medications, ramelteon is not a controlled substance and has no known potential for misuse. Medical uses
Insomnia
Ramelteon is approved for the treatment of insomnia characterized by difficulty with sleep onset in adults. In regulatory clinical trials, it was found to significantly reduce latency to persistent sleep (LPS). A 2009 pooled analysis of four clinical trials found that ramelteon at a dose of 8 mg reduced sleep onset by 13 minutes (30% decrease) relative to placebo on the first and second nights of use. Subsequent meta-analyses of longer-duration use have found that ramelteon decreases subjective sleep latency by about 4 to 7 minutes.