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Information about Ramelteon

Ramelteon is a melatonin receptor agonist that is used for the treatment of insomnia.

Liver safety of Ramelteon

Ramelteon has not been implicated in causing serum enzyme elevations or clinically apparent liver injury.

Mechanism of action of Ramelteon

Ramelteon (ra mel' tee on) is a synthetic melatonin receptor agonist with affinity for both the melatonin type 1 and type 2 receptors (MT1 and MT2). These receptors are believed to be involved in the maintenance of the circadian rhythm that regulates the normal sleep-wake cycle. Melatonin itself has been proposed as therapy of sleep disturbances including insomnia and jet lag, but systematic reviews and meta analyses of controlled trials of various melatonin formulations have failed to demonstrate consistent efficacy. In contrast, ramelteon was found to reduce the average latency to persistent sleep with little residual sleepiness the following day or rebound insomnia upon withdrawal.

FDA approval information for Ramelteon

Ramelteon was approved for use in chronic insomnia in the United States in 2005. It is available in 8 mg tablets under the brand name Rozerem. The recommended dose is 8 mg taken orally 30 minutes before going to bed.

Side effects of Ramelteon

Side effects are few but may include daytime somnolence, fatigue, dizziness and headache and rarely hypersensitivity reactions with angioedema of the tongue and larynx.

Sedatives and Hypnotics

Miscellaneous Agents


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