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Rozerem (Ramelteon) Prescription
Rozerem is specifically indicated for the treatment of chronic or transient (temporary) insomnia characterized by difficulty in falling asleep. The drug is safe for long-term use - the FDA approval allows physicians to prescribe Rozerem as long-term prescription treatment. Because ramelteon did not show evidence of abuse potential or dependence in clinical studies, Rozerem is the first and only non-scheduled hypnotic medication. It is a non-controlled substance by the U.S. DEA. Rozerem Advantages
Rozerem Disadvantages
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Drug Information
How does Rozerem works? Ramelteon is a melatonin MT1 and MT2 receptor agonist. Rozerem has a unique therapeutic 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, the drug 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 works without affecting other systems, such as benzodiazepine receptors, dopamine receptors, and opiate receptors. It has no effect on the activity of various enzymes. Prescription for Chronic Insomnia Rozerem (Ramelteon) is an effective treatment for chronic insomnia. Rozerem was investigated in a pair of randomized, double-blind studies designed to determine the efficacy of the drug for the treatment of chronic insomnia via polysomnography. This first study enrolled adults ages 18-64, who received one of two doses of the drug (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 the drug (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. Prescription for Transient Insomnia Rozerem is an effective medication for transient insomnia. A randomized, double-blind study investigated the single-dose efficacy of the drug in treating transient insomnia. The study enrolled healthy adults, who received a single dose of the drug at one of two levels (8 mg or 16 mg) or placebo before a single night of polysomnography analysis. The 8 mg dose significantly reduced mean latency to persistent sleep, vs. placebo. Rozerem and Next-Day Fatigue Ramelteon does not cause significant deficits of alertness, short term learning and memory performance, and ability to concentrate on the day following treatment. Withdrawal and Rebound Insomnia In clinical studies Rozerem has shown no potential for withdrawal effects and rebound insomnia following abrupt treatment termination. Abuse Potential Unlike many other hypnotic agents, clinical and animal trials of Rozerem did not revealed potential for physical dependence or abuse, and the drug is not a controlled substance. Side effects The most common side effects with Rozerem are:
How to take
Rozerem dosage The standard dose is 8 mg within 30 minutes of going to bed and there is no difference in adult and elderly dose recommendations. |
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