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New Long-Term Sleep Aid Lunesta Available Nationwide
by April 1
 Senior
citizens expected to be a major market 2 of 3 have sleep problems
March 30, 2005 Two out of three older adults have
sleep problems, according to the National Sleep Foundation, but help may
have arrived just around the corner at the local pharmacy. Lunesta, the
new insomnia drug approved by the FDA in December, is due to be
available nationwide by April 1, according to. Sepracor Inc., maker of
the drug.
Lunesta is a non-narcotic prescription sleep aid
that represents a new treatment option for those suffering from
insomnia, according to Sepracor. Lunesta helps people fall asleep
quickly, so it should only be taken right before going to bed. Most
people who took Lunesta slept peacefully all through the night, and woke
up ready to start their day. Lunesta is the first and only prescription
sleep aid approved for long-term use.
Based on published clinical reports, Lunesta is the
first pharmacological treatment that has demonstrated safety and
efficacy of long- term nightly use, says the NSF. According to Thomas
Roth, PhD, a sleep researcher at the Henry Ford Hospital, Detroit, "Lunesta(TM)
helps patients fall asleep and stay asleep throughout the night."
So far, Lunesta is the only prescription insomnia
remedy that doesn't have to carry a label suggesting that patients stop
the drug after 10 nights, according to a report by
Business Week. Sepracor persuaded the FDA to omit that restriction
following clinical trials showing the drug was safe over six months.
Besides playing up that patients can take Lunesta nightly, Sepracor will
stress that the drug helps keep patients asleep all night and that it
produces little hangover.
Symptoms of insomnia are extraordinarily common. More than one-half of
America's adults, 58% or 126 million people, experience at least one
symptom of insomnia a few nights a week, according to NSF's 2002 Sleep
in America poll. Insomnia is more prevalent among older adults and
women. It is a frequent problem for individuals with a variety of
medical and psychiatric conditions, and in shift workers. Insomnia can
include difficulty falling asleep as well as difficulty maintaining
sleep through the night.
The U.S. market for prescription sleep products,
not including off-label (not indicated for the treatment of insomnia)
use of central nervous system (CNS) agents for the treatment of
insomnia, was approximately $2.1 billion between November 2003 and
October 2004, representing a 20 percent increase over the same period
the previous year, according to IMS Health Information.
The manufacturer has issued specific instructions
for senior citizens. The recommended dosing to improve sleep onset
and/or maintenance is 2 mg or 3 mg for adult patients (18 to 64) and 2
mg for older adult patients (ages 65 and older). The 1 mg dose is for
sleep onset in older adult patients whose primary complaint is
difficulty falling asleep, they say.
The application for Lunesta contained data from 24
clinical trials, which included more than 2,700 adult and elderly
patients, and more than 60 preclinical studies.
Results of six randomized, placebo-controlled Phase
III studies for the treatment of chronic or transient insomnia in both
adult and older patients (ages 65 and older) were included as part of
the NDA package.
Data from a landmark, long-term (six-month),
double-blind, placebo-controlled safety and efficacy study in 788
patients were reviewed by the FDA as part of the NDA submission for
eszopiclone and served as a basis for the FDA's decision to not limit
LUNESTA's indication to short-term use. Sepracor's six-month study was
the first of its kind for a prescription non-benzodiazepine for the
treatment of insomnia. The results of this study were published in the
November 2003 issue of the journal SLEEP.
Sepracor says they continue to study LUNESTA in
adult and older adult patients in a comprehensive Phase IIIB/IV program.
The preliminary results of a Phase IIIB/IV, 545-patient, double-blind,
placebo-controlled, ten-week study evaluating the efficacy and safety of
LUNESTA in patients with insomnia and co-existing Major Depressive
Disorder (MDD) have been completed. Sepracor has submitted results of
this study to be considered by the American Psychiatric Association and
the Associated Professional Sleep Societies for presentation at their
respective scientific meetings in May and June of 2005.
Insomnia can be primary (not associated with
another medical condition or disease), but is often associated with
other health problems or disease including pain, depression, heart
disease and sleep disorders such as obstructive sleep apnea and restless
legs syndrome.
Insomnia can also be caused by certain medications
and lifestyle factors. If insomnia persists, a physician should be
consulted to ensure that the sleep problem is not due to another disease
and to ensure that it does not become conditioned or habitual. Chronic
insomnia may be associated with impaired cognitive functions such as
memory and concentration, a higher risk of mental health problems,
safety and occupational concerns, and reduced quality of life.
Insomnia treatment includes the recommendation to
adhere to the principles of good sleep hygiene, including behavioral
practices such as reducing caffeine in the diet and establishing
standard bedtimes. Healthcare professionals may treat insomnia by
behavioral and cognitive methods that promote relaxation, increase the
amount of bedtime actually spent sleeping, and address maladaptive sleep
expectations and attitudes like "I'll never fall asleep."
Pharmacotherapy, including use of hypnotic
medications that reduce time to fall asleep, increase total sleep time,
reduce awakenings, and improve sleep quality may be prescribed.
Information about insomnia and sleep disorders
effecting older adults can by found at the NSF
Click Here.
The National Sleep Foundation is an independent
nonprofit organization dedicated to improving public health and safety
by achieving understanding of sleep and sleep disorders, and by
supporting education, sleep-related research and advocacy.
Important Safety Information from Sepracor
It is important to note that because sleep
disturbances may be caused by underlying physical and/or psychiatric
disorders, symptomatic treatment of insomnia should be initiated only
after a careful evaluation of the patient. The failure of insomnia to
remit after 7-10 days of treatment may indicate the presence of a
primary psychiatric and/or medical illness that should be evaluated. Be
sure you have at least eight hours to devote to sleep before becoming
active. You should not engage in any activity after taking Lunesta that
requires complete alertness, such as driving a car or operating
machinery. You should use extreme care when engaging in these activities
the morning after taking Lunesta. Do not use alcohol while taking any
sleep medicine. All sleep medicines carry some risk of dependency. Side
effects may include unpleasant taste, headache, drowsiness and
dizziness.
For more information from the company
Click Here.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical
company dedicated to treating and preventing human disease through the
discovery, development and commercialization of innovative
pharmaceutical products that are directed toward serving unmet medical
needs. Sepracor's drug development program has yielded an extensive
portfolio of pharmaceutical compound candidates with a focus on
respiratory and central nervous system disorders. Sepracor's corporate
headquarters are located in Marlborough, Massachusetts.
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