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Rozerem (Ramelteon)
Rozerem is specifically indicated for the treatment of chronic or transient (temporary) insomnia characterized by difficulty in falling asleep. It is suitable for long-term use. Because ramelteon did not show evidence of abuse potential or dependence in clinical studies, Rozerem is the first and only non-scheduled hypnotic. It is a non-controlled substance by the U.S. DEA. Rozerem Advantages
Rozerem Disadvantages
How does Rozerem work? Ramelteon is a melatonin MT1 and MT2 receptor agonist. It has a unique mechanism of action that selectively targets two receptors located in the brain's suprachiasmatic nucleus (SCN). The SCN is known as the body's "master clock" because it regulates 24-hour, or circadian, rhythms including the sleep-wake cycle. By binding selectively at these receptors, ramelteon mimics and enhances the action of melatonin, which maintains the circadian sleep rhythm through the inhibitory activity of MT1 and MT2 systems on excitatory wakefulness-promoting circuits in the suprachiasmic nucleus. Ramelteon does not affect other systems, such as benzodiazepine receptors, dopamine receptors, and opiate receptors. It has no effect on the activity of various enzymes. Chronic Insomnia Rozerem is an effective hypnotic for chronic insomnia. Ramelteon was investigated in a pair of randomized, double-blind studies designed to determine its efficacy for chronic insomnia via polysomnography. This first study enrolled adults ages 18-64, who received one of two doses of Ramelteon (8 mg or 16 mg) or placebo nightly before bed for 35 days. Sleep analysis via polysomnography was performed on days 1, 2 of weeks 1, 3 and 5. The second study enrolled elderly patients age 65 and older in a three-period crossover study. Participants received one of two doses of Ramelteon (4 mg or 8 mg) or placebo in each study period, with polysomnography analysis performed for 2 consecutive nights in each period. In both studies, each dose of Rozerem produced significant reductions in average latency to persistent sleep onset, compared to placebo. Transient Insomnia Rozerem is an effective for transient insomnia. A randomized, double-blind study investigated the efficacy of Rozerem in treating transient insomnia. The study enrolled healthy adults, who received ramelteon (8 mg or 16 mg) or placebo before a night of polysomnography analysis. The 8 mg dose significantly reduced mean latency to persistent sleep, vs. placebo. Abuse Potential Unlike many other hypnotics, clinical and animal trials of Rozerem did not revealed potential for physical dependence or abuse. |
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