What is the role of ramelteon (Rozerem) in the treatment of insomnia?

Updated: Sep 11, 2018
  • Author: Jasvinder Chawla, MD, MBA; Chief Editor: Selim R Benbadis, MD  more...
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Ramelteon (Rozerem), a melatonin receptor agonist, is approved by the FDA for use in persons with insomnia. It has been shown to have no potential for abuse and, as such, is the first nonscheduled prescription drug available in the United States for the treatment of insomnia.

Ramelteon is a specific melatonin receptor agonist that binds to the melatonin MT1 and MT2 receptors. It has a half-life of 1-3 hours. The MT1 receptor attenuates the alerting signal of the suprachiasmatic nucleus (SCN) clock, and the MT2 receptor phase shifts (advances) the SCN clock to promote sleep.

Controlled trials have shown a decrease in sleep latency but no change in wake time after sleep onset and no next-morning residual effects. Additionally, studies thus far on elderly patients have shown no impairment in night balance, mobility, or memory. [86, 87, 88]

This medication is suited for patients with sleep-onset insomnia, particularly for elderly patients with gait disorders who have an increased risk of falls and in patients with a history of substance abuse. The typical starting dose is 8 mg before bedtime. Ramelteon is not effective for sleep-maintenance insomnia. The AASM recommends ramelteon for the treatment of sleep onset insomnia (versus no treatment). [6]

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