LUNESTA(R) Study of Patients with Insomnia and Co-Morbid Generalized Anxiety Disorder (GAD) Published in Archives of General Psychiatry
-- Study is first published, large-scale, double-blind randomized
trial examining use of insomnia and anxiety treatments in
patients with co-morbid insomnia and GAD
-- Co-administration of LUNESTA(R) brand eszopiclone and
anti-anxiety agent associated with significantly improved
measures of sleep, daytime functioning, anxiety and mood
-- At least two-thirds of patients with GAD also have at least
one symptom of co-morbid insomnia
MARLBOROUGH, Mass.--(Business Wire)--
Sepracor Inc. (Nasdaq: SEPR) today announced the publication of a
study of LUNESTA tablets in patients with insomnia and co-morbid
generalized anxiety disorder (GAD) in the May issue of the Archives of
General Psychiatry. This 595-patient study examined the safety and
efficacy of LUNESTA co-administered with escitalopram oxalate, which
is commonly used in the treatment of anxiety, versus co-administration
of escitalopram and placebo in patients with insomnia and co-existing
GAD. The study also evaluated the potential for co-administration of
LUNESTA to increase the magnitude and/or accelerate the anxiolytic
response versus escitalopram alone.
"Patients suffering from insomnia may have co-existing medical and
psychiatric illnesses," said Mark H.N. Corrigan, M.D., Executive Vice
President, Research and Development at Sepracor. "In fact, studies
indicate that approximately ten percent of the adult population
suffers from chronic insomnia, and that in approximately 80 percent of
these patients, insomnia co-exists with other psychiatric and medical
illnesses. The results of this study are consistent with results of
other studies of LUNESTA evaluating insomnia with major depressive
disorder and symptoms associated with perimenopause, which have shown
that improvements in sleep can have positive effects on the co-morbid
condition."
"To my knowledge, this is the first large-scale, double-blind,
randomized clinical trial published that assessed the use of an
insomnia treatment in conjunction with a selective serotonin reuptake
inhibitor, or SSRI, in the treatment of patients with insomnia and
co-morbid GAD," said W. Vaughn McCall, M.D., Professor and Chairman of
the Department of Psychiatry and Behavioral Medicine at the Wake
Forest University School of Medicine. "In this study, patients with
insomnia and co-morbid GAD who took LUNESTA and escitalopram
co-therapy showed improvements in measures of sleep and anxiety. Given
the high incidence of insomnia symptoms co-existing with GAD, and the
results seen in this clinical trial, I believe that further study of
insomnia and its relationship to GAD is warranted."
In this multicenter, randomized, double-blind, placebo-controlled,
parallel-group study, patients 18 to 64 years of age who met
DSM-IV-TR(R)(1) criteria for insomnia and GAD were administered 10 mg
of escitalopram nightly, plus either placebo or LUNESTA 3 mg nightly
for eight weeks. The eight weeks of double-blind treatment were
followed by a two-week run-out period in which all patients were
administered escitalopram and placebo to evaluate the potential for
rebound insomnia and withdrawal effects associated with LUNESTA
discontinuation.
Patients treated with LUNESTA and escitalopram co-therapy
demonstrated significant (p<0.001) improvement in all measured sleep
parameters when averaged over the eight-week, double-blind period,
including the primary endpoint of sleep latency (25-minute decrease in
sleep onset), sleep maintenance and total sleep time (TST; 60-minute
increase), compared with patients who were treated with escitalopram
and placebo (11.5-minute decrease for sleep onset and 35-minute
increase for TST). LUNESTA-escitalopram co-therapy also resulted in
significant (p< or =0.007) patient-reported improvements from baseline
in daytime symptoms of insomnia, including daytime alertness, ability
to function, ability to concentrate and physical well-being compared
to escitalopram-placebo administration when averaged over the
treatment period. Consistent with other published studies of LUNESTA,
there was no evidence of tolerance (diminution of effect over time),
rebound insomnia or serious withdrawal syndrome following
discontinuation from this study.
When evaluating anxiolytic effects of the two treatment arms,
patients administered LUNESTA and escitalopram co-therapy demonstrated
significant (p<0.05) improvements from baseline in total HAM-A
(Hamilton Anxiety Rating Scale, a standard scale used to assess
anxiety in clinical trials and consisting of a list of symptoms
commonly associated with anxiety, including insomnia) scores for each
week of the study. CGI-I (Clinical Global Impression of Improvement, a
scale that captures physicians' ratings of patients' mental illness
symptoms) scores were significantly (p<0.02) improved in the
LUNESTA-escitalopram treatment group at each time point versus the
placebo-escitalopram group. CGI-S (Clinical Global Impression of
Severity) scores were not significantly different after Week 1.
Since anxiety and depression can co-exist, symptoms of depression
were also evaluated using the clinician-rated HAM-D17 (Hamilton
Depression Rating Scale) throughout the study. The Hamilton Depression
Rating Scale is a standard scale used to assess depression in clinical
trials and consists of a list of symptoms commonly associated with
depression (including insomnia).
The LUNESTA-escitalopram group demonstrated reductions from
baseline in HAM-D17 scores that were statistically significantly
greater (p<0.05) than those seen in the placebo-escitalopram group at
each week of the eight-week, double-blind treatment period. In this
study, LUNESTA and escitalopram were generally well tolerated.
This publication can be accessed on the Archives of General
Psychiatry web site at www.archgenpsychiatry.com.
Approximately ten percent of adults in the U.S. suffer from
chronic insomnia, symptoms of which include difficulty falling asleep,
awakening frequently during the night and/or waking up too early with
an inability to fall back to sleep, resulting in patients feeling
unrefreshed.
About LUNESTA
LUNESTA is indicated for the treatment of insomnia in patients 18
years of age and older who are experiencing difficulty falling asleep
and/or maintaining sleep through the night. LUNESTA is not indicated
as a treatment for anxiety, depression or any other medical or
psychiatric disorder other than insomnia. LUNESTA is available in 1
mg, 2 mg and 3 mg tablets and treatment should be individualized based
on patient age, history and insomnia symptoms. LUNESTA is a Schedule
IV controlled substance.
LUNESTA works quickly and should only be taken immediately before
bedtime. Patients should have at least eight hours to devote to sleep
before becoming active. Patients should not engage in any activity
after taking LUNESTA that requires complete alertness, such as driving
a car or operating machinery. Patients should use extreme care when
engaging in these activities the morning after taking LUNESTA.
Patients should not use alcohol while taking any sleep medicine. Most
sleep medicines carry some risk of dependency. As with all sleep
medicines, somnambulism (sleepwalking), including eating or driving
while not fully awake, with amnesia for the event, has been reported.
Additionally, rare cases of severe allergic reactions have been
reported. Patients who report these events should discontinue
treatment and should not be rechallenged with LUNESTA. Patients should
not use sleep medicines for extended periods without first talking to
their doctor. Patients should see their doctor if they experience
unusual changes in thinking or behavior, or if sleep problems do not
improve in 7 to 10 days as this may be due to another medical
condition. Side effects may include unpleasant taste, headache,
drowsiness and dizziness.
LUNESTA, like other sleep medicines, may produce additive
CNS-depressant effects when co-administered with other psychotropic
medications, anticonvulsants, antihistamines, ethanol, and other drugs
that themselves produce CNS depression. Dosage adjustment may be
necessary when LUNESTA is administered with other CNS-depressant
agents because of the potentially additive effects. In primarily
depressed patients, worsening of depression, including suicidal
thoughts and actions (including completed suicides) have been reported
in association with the use of sleep medicines; therefore, the least
amount of drug that is feasible should be prescribed for the patient
at any one time.
About Sepracor
Sepracor Inc. is a research-based pharmaceutical company dedicated
to treating and preventing human disease by discovering, developing
and commercializing innovative pharmaceutical products that are
directed toward serving large and growing markets and unmet medical
needs. Sepracor's drug development program has yielded a portfolio of
pharmaceutical products and candidates with a focus on respiratory and
central nervous system disorders. Currently marketed products include
LUNESTA(R) brand eszopiclone, XOPENEX(R) brand levalbuterol HCl
Inhalation Solution, XOPENEX HFA(R) brand levalbuterol tartrate
Inhalation Aerosol, BROVANA(R) brand arformoterol tartrate Inhalation
Solution and OMNARIS(TM) brand ciclesonide Nasal Spray. Sepracor's
corporate headquarters are located in Marlborough, Massachusetts.
(1) Diagnostic and Statistical Manual of Mental Disorders - Fourth
Edition- Text Revision
LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered
trademarks of Sepracor Inc. DSM-IV-TR is a registered trademark of the
American Psychiatric Association. OMNARIS is a trademark of Nycomed
GmbH.
For a copy of this release or any recent release, visit Sepracor's
web site at www.sepracor.com.
Sepracor Inc.
David P. Southwell, 508-481-6700
Chief Financial Officer
or
Jonae R. Barnes, 508-481-6700
Sr. Vice President
Investor Relations
Copyright Business Wire 2008
