From the Wires
ROZEREM(TM) (ramelteon) Now Available in U.S. Pharmacies
First and Only Non-Scheduled Prescription Sleep Medication
By: Marketwired .
Sep. 26, 2005 10:00 AM
LINCOLNSHIRE, IL -- (MARKET WIRE) -- 09/26/05 -- Takeda Pharmaceuticals North America, Inc. today announced that ROZEREM(TM) (ramelteon) 8-mg tablets are now available by prescription in pharmacies across the U.S. for the treatment of insomnia characterized by difficulty with sleep onset. ROZEREM is the first prescription insomnia medication with a new therapeutic mechanism of action in 35 years, and can be prescribed 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. As a result, ROZEREM is not designated as a controlled substance by the U.S. Drug Enforcement Administration (DEA). With the exception of ROZEREM, all other prescription medications indicated for insomnia are classified as controlled substances by the DEA, most as Schedule IV drugs.
"The availability of ROZEREM represents the second Takeda-discovered-and-developed product to reach physicians and patients in our brief history," said Mark Booth, president of Takeda Pharmaceuticals North America. "We are excited to be able to offer an important new option for people living with insomnia that has not shown the potential for abuse or dependence."
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.
Approximately 60 million people in the United States suffer from insomnia, yet the vast majority remains undiagnosed and untreated. Insomnia is characterized by difficulty falling asleep, difficulty staying asleep, or poor quality sleep, leading to impairment of next-day functioning.
Insomnia has been linked to a variety of health problems, including obesity, diabetes, hypertension, heart disease and depression. According to the U.S. Surgeon General, nearly $15 billion annually is spent on healthcare related to insomnia, while $50 billion is lost in productivity.
About ROZEREM(TM) (ramelteon)
ROZEREM(TM) (ramelteon) 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 greater than 2% incidence difference from placebo were somnolence, dizziness, and fatigue. For complete prescribing information, please visit www.rozerem.com.
Takeda Pharmaceuticals North America, Inc.
Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America, Inc. is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. In the United States, Takeda currently markets oral diabetes, insomnia, and cholesterol-lowering treatments, and through the Takeda Global Research & Development Center, Inc., the company has a robust pipeline with compounds in development for diabetes, cardiovascular disease, sepsis, and other conditions. Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. To learn more about the company and its products, visit www.tpna.com.
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