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Lunesta: New Insomnia Drug Now Available in
Most Pharmacies, Company Says
 Information to SeniorJournal.com says clinical trials
prove value of long-term use for senior citizens
By Tucker Sutherland, editor
April 7, 2005 There has been general confusion
about the availability of the new prescription sleep aid, Lunesta, that
was approved by the FDA late last year but has been slow to reach the
market. The company, Sepracor, Inc., issued a news release today saying
it is now available in most pharmacies nationwide. Many senior citizen
insomnia suffers have been eager for the non-narcotic drug that is the
first sleep aid approved for long-term use.
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The company also claims it is the first to be shown
to help patients fall asleep quickly and also sleep through the night
and sent SeniorJournal.com a fact sheet on a clinical trial involving
only senior citizens that had chronic insomnia.
This study shows most elderly patients receiving
Lunesta were able to fall asleep fast and maintain sleep throughout the
night, without adverse next-day residual effects and with improvements
in patient-reported measures of next-day function.
The company pointed out, too, that they consider
Lunesta particularly important to the elderly because of its
availability for long-term use for those with insomnia induced by
depression, Alzheimers, Parkinsons or chronic pain like arthritis. It
is the only sleep aid over-the-counter of prescription approved for
long-term use by the FDA.
(See company fact sheet on clinical trial of
elderly below this article)
"Lunesta is a new prescription, non-narcotic sleep
aid approved to treat insomnia and, unlike other sleep aids, is approved
for long-term use," said John Winkelman, M.D., Ph.D., Associate Director
for the Sleep Disorders Program at Brigham and Women's Hospital, Boston.
"Lunesta is an important treatment option for the millions of people who
have the ongoing problem of not getting a good night's sleep."
Lunesta is approved as a prescription, non-narcotic
sleep aid to treat insomnia. Insomnia symptoms can include difficulty
falling asleep and/or not sleeping all through the night. Lunesta has
been studied in patients for up to 12 months and in more than 30
clinical trials enrolling more than 4,700 patients.
"I am extremely pleased that millions of patients
who have trouble sleeping, whether it be on a short- or long-term basis,
have an effective new prescription treatment option available in their
local pharmacy," continued Winkelman. "I expect that Lunesta, with its
approval for long-term use and effectiveness in helping people stay
asleep through the night, will allow most people who suffer from
insomnia to get a refreshing night of sleep without feeling groggy the
next day."
About Insomnia
Insomnia can include difficulty falling asleep as
well as difficulty maintaining sleep through the night. An estimated 100
million adult Americans suffer from either chronic or
occasional
insomnia.(1) Symptoms of insomnia include difficulty falling asleep,
awakening frequently during the night, waking up too early, an inability
to fall back to sleep, or awakening feeling unrefreshed. Insomnia can be
a serious condition. If left untreated, it may become progressively
worse and in turn, potentially affect a person's emotional, mental and
physical health.
Important Safety Information
Lunesta should only be taken immediately before
bedtime. 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. Do not use sleep medicines for extended periods without
first talking to your doctor. Side effects may include unpleasant taste,
headache, drowsiness and dizziness.
Please visit
http://www.sepracor.com or
http://www.Lunesta.com to access the FDA-approved labeling text for
Lunesta.
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. The company's
commercialization efforts are carried out by its U.S.-based,
1,250-person, primary care and specialty-oriented sales force.
Sepracor's corporate headquarters are located in Marlborough,
Massachusetts.
(1) Extrapolated to current population from 2000
census based on Ancoli- Israel et al. SLEEP. 1999;22 (suppl
2):S347-S353.
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FACT SHEET
Clinical Trial of Older
People with Chronic Insomnia
Scharf
M, McCall WV, Erman M, Rubens R. Patient-Reported Efficacy
of Eszopiclone in Elderly Patients with Chronic Insomnia.
Journal of the American Geriatrics Society.
2004;52(4);Suppl:S14.
Study
Design
Ψ
Participants
in the double-blind, placebo-controlled, parallel-group
study were randomly assigned to receive LUNESTA (eszopiclone)
1 mg (n=74) or 2 mg (n=79) or placebo (n=81) nightly for two
weeks
·
Patients in
the study ranged from ages 64-85 with a DSM-IV diagnosis of
primary insomnia
Ψ
Sleep
latency, or how fast a person falls asleep, was the primary
study endpoint
·
Secondary
endpoints included subjective measurements of total sleep
time, time awake after falling asleep, and the quality and
depth of sleep
·
Measurements
of improvement were recorded using an interactive
voice-response system. Patients reported the amount of time
it took to fall asleep and rated subjective sleep
parameters, like sleep quality, on a scale of zero to 10
Study Results
Data from this study showed that most elderly patients
receiving LUNESTA were able to fall asleep fast and maintain
sleep throughout the night, without adverse next-day
residual effects and with improvements in patient-reported
measures of next-day function.
Ψ
Compared to
placebo, LUNESTA 1 mg significantly decreased the time it
took to fall asleep
Ψ
Compared to
placebo, LUNESTA 2 mg significantly decreased the time it
took to fall asleep, decreased time awake during the night,
increased total sleep time, and reduced the number of naps
and time spent napping in those patients who napped
Ψ
Elderly
patients receiving LUNESTA 2 mg also experienced:
·
Statistically
significant improvements in sleep quality
·
Improvement
in measures of next-day functions such as alertness and a
sense of physical well-being
Ψ
LUNESTA was
well tolerated, with headache as the most common adverse
event for both the placebo and LUNESTA groups
Significance of Results
Ψ
Older adults
need the same amount of sleep as younger adults, but trouble
sleeping is more prevalent in the elderly. This study
supported the FDA finding that LUNESTA is safe and effective
for treating insomnia in this population
About LUNESTA
Ψ
LUNESTA is a
new sleep medication approved by the FDA to treat insomnia
(trouble sleeping) including difficulty falling asleep
and/or staying asleep all through the night. LUNESTA helps
people wake up feeling refreshed and is the first and only
sleep medication (prescription or over-the-counter) approved
for long-term use
For
additional information about LUNESTA, please visit the
LUNESTA website at www.LUNESTA.com.
Important
Safety Information
Be sure
you have at least eight hours to devote to sleep before
becoming active. Until you know how youll react to Lunesta,
you should not drive or operate machinery. Avoid taking
Lunesta with alcohol. All sleep medicines carry some risk of
dependency. Side effects may include unpleasant taste,
headache, drowsiness and dizziness. |
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