Rozerem
Insomnia Drug
Rozerem is the first and only prescription sleep medication that has shown no evidence of abuse and dependence and, as a result, has not been designated as a controlled substance by the DEA. With the exception of Rozerem, all other prescription
medications indicated for insomnia are classified as Schedule IV controlled substances by the DEA. Additionally, Rozerem is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years.
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.
Rozerem (ramelteon) is a melatonin receptor agonist, with high binding affinity at the melatonin MT1 and MT2 receptors. The drug exerts high selectivity for these receptors over the MT3 receptor, which has been implicated in a number of additional
systems.
Ramelteon is specifically indicated for the treatment of insomnia characterized by difficulty in falling asleep. Unlike many other hypnotic agents, clinical and animal trials of Rozerem did not yield evidence of formation of physical dependence or
abuse potential, and the drug is not a controlled substance; overall adverse events occured at rates generally comparable to placebo. These properties suggest that Rozerem may be well tolerated when administered for long treatment courses.
Rozerem is supplied as a round pale orange-yellow film coated tablet. The recommended dose of the drug is one 8 mg tablet once daily, 30 minutes prior to going to bed.
The Rozerem NDA, submitted in September 2004 by Takeda Global Research & Development Center, Inc., was based on data collected from an extensive clinical research program, including recently completed clinical studies with more than 4,200
patients ages 18 to 93. In one study, 472 patients received single daily doses of Rozerem for up to one year. Also, based on recently presented clinical trials, Rozerem has been shown to be safe for older adults, as well as those who have
mild-to-moderate chronic obstructive pulmonary disease (COPD) and mild-to-moderate sleep apnea.
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Please remember that cosmetic differences such as color of pill, packaging, etc. are possible due to marketing or packaging issues and vary from provider to provider.
We have listed alternative names like the Mexican name, the manufacturer's name of the drug if it's different than the U.S. version of the same drug for your convenience.
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