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Rozerem: New Sleep Drug for Long-Term Use Expected
in September
FDA gives its approval as treatment for difficulty
with sleep onset
July 27, 2005 There is a new opportunity coming
on the market in September for senior citizens desperate for a good
nights sleep. The Food and Drug Administration has approved Rozerem (ramelteon)
for the treatment of insomnia.
Specifically approved for insomnia characterized by
difficulty with sleep onset, the 8-mg Rozerem tablets can be prescribed
by physicians for long-term use in adults.
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 U.S.
Drug Enforcement Administration (DEA), according to the manufacturer
Takeda Pharmaceuticals North America, Inc.
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, and will be available for patients by
late September, the companys announcement stated..
"People with insomnia are not only affected by
their sleeplessness at night; insomnia's impact is also in how they feel
and function the next day," said Thomas Roth, Ph.D., director of the
Sleep Disorders and Research Center, Detroit, Mich. "Current therapies
often used for insomnia work by broadly inhibiting the activity of
neurons in the brain. Ramelteon treats insomnia by specifically
affecting the activity of neurons in an area of the brain involved in
the sleep-wake process, and has been shown to carry no risks of abuse,
withdrawal, or dependency, and negligible risk for next-day 'hangover'
effects."
"Rozerem represents an exciting new option in sleep
medicine that we anticipate can help millions of people who live with
sleepless nights and sluggish days," said Yasuchika Hasegawa, president
and chief operating officer of Takeda. "The approval of Rozerem marks a
major milestone for Takeda as we seek to bring innovative therapies to
patients in a variety of therapeutic areas."
Rozerem has a unique therapeutic mechanism of
action that selectively targets two receptors located in the brain's
suprachiasmatic nucleus (SCN), the company says. The SCN is known as the
body's "master clock" because it regulates 24-hour, or circadian,
rhythms including the sleep-wake cycle.
The Rozerem application was submitted to the FDA in
September 2004 by Takeda Global Research & Development Center, Inc., and
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,
the company notes, 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.
About Insomnia
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
Rozerem is indicated for the treatment of insomnia
characterized by difficulty with sleep onset. Rozerem should not be used
in patients with hypersensitivity to ramelteon or any components of the
formulation. Rozerem can be prescribed for long-term use. However,
failure of insomnia to remit after a reasonable period of time,
worsening of insomnia, or the emergence of new cognitive or behavioral
abnormalities after taking Rozerem should be evaluated, as such symptoms
may be the result of an unrecognized underlying medical disorder. In
primarily depressed patients, worsening of depression, including
suicidal ideation, has been reported in association with the use of
hypnotics.
Rozerem should not be used by patients with severe
hepatic impairment, or in patients in combination with fluvoxamine.
Rozerem has not been studied in subjects with
severe sleep apnea or severe COPD and is not recommended for use in
those populations. Patients should be advised to exercise caution if
they consume alcohol in combination with Rozerem.
Rozerem has been associated with decreased
testosterone levels and increased prolactin levels. As a result,
healthcare professionals should be mindful of any unexplained symptoms
possibly associated with such changes in these hormone levels. Rozerem
has not been studied in children or adolescents, and the effects in
these populations are unknown.
Rozerem should be taken within 30 minutes before
going to bed and activities should be confined to those necessary to
prepare for bed. Rozerem should not be taken with or immediately after a
high-fat meal. Engaging in hazardous activities that require
concentration (such as operating a motor vehicle or heavy machinery)
after taking Rozerem should be avoided.
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, 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.
For more information about Rozerem from the FDA,
including labeling information,
Click Here, to a 24-page pdf document.
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