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Takeda researchers discovered ROZEREMTM(ramelteon) (then TAK-375) in 1996.
In 2005, the U.S. Food and Drug Administration approved ROZEREM 8 mg tablets for the treatment of insomnia
characterized by difficulty with sleep onset. ROZEREM was approved for long-term use in adults.
ROZEREM is the first and only prescription sleep medication that has shown no evidence of abuse* and dependence in clinical
studies, and, as a result, has
not been designated as a controlled substance. 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 is indicated for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM can be prescribed for long-term use.
ROZEREM should not be used in patients with hypersensitivity to any components of the formulation, severe hepatic impairment, or in combination with
fluvoxamine. Failure of insomnia to remit after a reasonable period of time should be medically evaluated, as this may be the result of an unrecognized
underlying medical disorder. Hypnotics should be administered with caution to patients exhibiting signs and symptoms of depression.
ROZEREM has not been studied in patients with severe sleep apnea, severe COPD, or in children or adolescents. The effects in these populations are unknown.
Exercise caution if consuming alcohol in combination with ROZEREM.
ROZEREM has been associated with decreased testosterone levels and increased prolactin levels. Health professionals should be mindful of any unexplained
symptoms possibly associated with such changes in these hormone levels. ROZEREM should not be taken with or immediately after a high-fat meal.
ROZEREM should be taken within 30 minutes before going to bed and activities confined to preparing for bed.
The most common adverse events seen with ROZEREM that had at least a 2% incidence difference from placebo were somnolence, dizziness, and fatigue.
For complete prescribing information, please visit www.rozerem.com or view the
ROZEREM Complete Prescribing Information.
* A randomized, single-center, double-blind, dose run-up study (N=6) and a single-center,
randomized, double-blind, placebo-controlled crossover study (N=14) specifically assessed the
abuse liability of Rozerem in patients with a history of substance abuse.
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Clinical trials are research studies conducted on new drugs or treatments in the
pharmaceutical industry to test if they are safe and effective for patients. A clinical
trial seeks to answer questions and find solutions to provide patients the safest, best
treatment for a disease or illness.
Clinical trials depend on people who volunteer to try a new drug or treatment. In
some cases, a drug has not yet been approved by the Food and Drug Administration (FDA)
to be sold in the United States. Or, the drug has been approved, but it is being tested
for a different treatment or additional information.
There are four different "phases" of clinical development:
- Phase 1: This type of trial involves a small group of people (20-80), and it is the first time a drug is tested in people. Researchers study whether the drug is safe and identify side effects and safe dosage amounts. This phase usually includes healthy volunteer subjects.
- Phase 2: This type of trial involves more people (100-300) than a Phase I trial, and it is typically is the first time the drug is tested in a patient population for which the drug is being developed. The primary purpose for this type of trial is to assess the drug’s effectiveness in the patient population for which it is intended. Researchers continue to study the drug’s safety
- Phase 3: During this phase of clinical development, trials usually involve a large group of people (1,000-3,000). Researchers evaluate how the patients are reacting to the drug – evaluating whether the drug is helping treat the patient as it should, monitoring additional side effects, comparing it to commonly used treatments and continuing to study ways for the drug to be used safely
- Phase 4: Commonly called post-marketing studies, this type of trial continues to focus on the drug’s safety, effectiveness and the best way the drug should be used.
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For more information please view:
Glossary of Clinical Trials
Clinical Trials Frequently Asked Questions
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