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Treat Insomnia - Buy Rozerem without
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Introducing...Rozerem,
a new development in sleep therapy. To learn more, please read the
prescribing information. What purpose does sleep serve in our lives? Is
it to refresh the body-or is it to recharge the mind? Experts aren't
sure, but something we can all agree on is that sleep is essential for
everyone. Exciting advances in neuroscience have provided insight into
how the sleep cycle is regulated, which has led to new treatment options
for insomnia.
Rozerem™ is indicated for the treatment
of insomnia characterized by difficulty falling asleep. 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. Studies have not shown
an increase in tolerance to Rozerem after a prolonged period of time,
meaning a increase in dosage over time is not usually warranted. Unlike
all other prescription medications for insomnia, Rozerem is not
considered to be a drug with abuse potential, and is not a scheduled
drug.
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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 promotes sleep by targeting the SCN.
Rozerem selectively binds to MT1 and MT2 receptors, which are found
in the SCN. This helps promote sleep. Rozerem does not
target GABA receptors. The selective binding profile of
Rozerem may explain the absence of any observed anxiolytic,
myorelaxant, and amnesic effects in clinical investigations.
Rozerem Side
Effects
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.
Rozerem targets the normal
sleep-wake cycle. Sleep is regulated by the internal master
clock in the suprachiasmatic nucleus, or the SCN. Because
Rozerem works by selectively binding to receptors in the SCN, it
doesn’t act by general central nervous system depression—which may
explain the absence of abuse potential.[
FDA
Approves Rozerem
The FDA has approved Rozerem (ramelteon), the first melatonin receptor
agonist, for the treatment of insomnia. Unlike other modern sleeping
pills, Rozerem was not designated as a controlled substance.
Clinical trials showed no evidence of dependance or abuse of the drug,
which was approved at the 8 mg dosage to help patients who suffer from
acute or chronic insomnia. Melatonin is believed to be involved in the
maintenance of the circadian rhythm underlying the
normal sleep-wake cycle.
"It
really is the first of prescription (sleep aid) drugs in recent times to
not be scheduled," said Robert Meyer, M.D., director of the pertinent
office of drug evaluation at the FDA. "I suspect that will be something
that will differentiate it from the others."
Manufactured by Takeda Pharmaceuticals North America, Rozerem works by
targeting two receptors, MT1 or MT2, in the suprachiasmatic nucleus,
which controls circadian rhythms. The activity of Rozerem at the MT1 and
MT2 receptor level is believed to contribute to its sleep-promoting
properties, said Takeda.
Takeda Pharmaceuticals North America, Inc. is a new kind
of pharmaceutical company. We are dedicated to serving patients by
providing innovative products that improve their lives with better
healthcare. With a foundation built on the tremendous success of ACTOS®
(pioglitazone HCl) as well as a robust, early-stage pipeline, TPNA is
poised to realize its vision of becoming a world class pharmaceutical
company.
Rozerem Study
New Drug Shows Significant Reduction In Time To Fall Asleep, With No
Evidence Of Rebound Insomnia Or Withdrawl Effects.
Results of a sub-analysis from a Phase III clinical study showed that
ROZEREMTM (ramelteon) significantly reduced time to fall asleep in
adults with chronic insomnia and showed no evidence of rebound insomnia
or withdrawal effects. The results were presented today at the 2006
Annual Meeting of the American Academy of Neurology.
In this placebo-controlled analysis, approximately two-thirds of
patients who received 8 mg of ROZEREM experienced at least a 50 percent
reduction in the time it took them to fall asleep. Study participants
also experienced no rebound insomnia or withdrawal effects following
discontinuation of treatment with ROZEREM. Rebound insomnia is the
worsening of insomnia symptoms after a person stops taking their
insomnia medications.
"These data show that ROZEREM can be effective in helping patients fall
asleep faster without rebound insomnia and other withdrawal effects,"
said Thomas Roth, PhD, director of the Sleep Disorders and Research
Center, Detroit, Mich. "This may represent another option for patients
who are looking for a sleeping medication that is right for them."
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