Ramelteon for the treatment of insomnia
Ramelteon (Rozerem), a highly selective antagonist for melatonin receptors type 1 (MT1) and type 2 (MT2) is a hypnotic drug approved by FDA (Food and Drug Administration) in the treatment of insomnia.
Twelve randomized controlled trials examined the efficacy and tolerability of Ramelteon.
In 2 clinical trials, treatment with ramelteon 4-32mg of patients with primary insomnia has produced significant reductions in time to persistent sleep latency compared with placebo (p <0.001).
In addition, improvements were observed in the total sleep time (p <0.001), although increases in total sleep time were seen only during the night 1-2 in the second study.
Similarly, the improvements in sleep has been reported only on nights 1-2 second trial (p <0.001).
In elderly patients with primary insomnia, significant reductions in persistent sleep latency was observed with ramelteon 4-8mg (p = 0.008), but the average latency of persistent sleep was more than 70 minutes.
The total sleep time was significantly increased in group 4 mg Ramelteon (p = 0.004):
A second study in elderly patients has found a persistent reduction in sleep latency with ramelteon 4 mg (p <0.001) and 8mg (p <0.01), and a significant increase in total sleep time (p <0.05 and p <0.01, respectively).
The sleep efficiency was improved for patients treated with 4 mg (p <0.05) and 8mg (p <0.01).
In general, the mean reduction in sleep latency persist reported in clinical studies that evaluated Ramelteon has varied between 10 and 19 minutes, the average increase of total sleep time was between 8 and 22 minutes.
The most common adverse events observed with ramelteon were headache (7%), dizziness (5%), somnolence (5%), fatigue (4%) and nausea (3%). (Xagena2007)