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Data Show Efficacy and Safety of Eszopiclone in Elderly Patients With Insomnia

Data Showed Improvements in Both Polysomnographic and Patient-Reported Sleep Measures

MARLBOROUGH, MA -- October 12, 2006 -- Sepracor Inc. today announced the publication of results of a large, randomized, double-blind, placebo-controlled, two-week study of Lunesta® brand of eszopiclone for the treatment of insomnia in elderly patients.

The study was conducted in 49 centers across the U.S. and included elderly patients (64-86 years of age; n=264) who met Diagnostic Statistical Manual – Revision IV (DSM-IV®) criteria for primary insomnia and screening polysomnographic (PSG; a type of study conducted in a sleep laboratory) criteria. Patients were randomized to two weeks of nightly treatment with either Lunesta 2 mg or placebo.

Efficacy and safety were assessed at overnight sleep laboratory visits using PSG measures and Interactive Voice Response System (IVRS) morning and evening questionnaires, and through patient-reported IVRS morning and evening questionnaires at home. The results were published in the September 2006 edition of the journal, Current Medical Research and Opinion.

The study showed that elderly patients with chronic primary insomnia who were administered Lunesta 2 mg experienced significant (P <.05) improvements in measures of sleep maintenance (ability to sleep through the night), sleep induction (time to fall asleep) and sleep duration (total sleep time), as assessed by both PSG objective measurements and patient-reported subjective measures, versus those patients administered placebo.

"Chronic insomnia is a serious condition that is more prevalent in elderly adults than in the general population. However, due to the comparatively limited number of studies that have been performed in elderly patients, there is very little patient-reported or PSG data examining the effectiveness of sleep aids in older adults," said W. Vaughn McCall, director of the sleep laboratory at Wake Forest University Baptist Medical Center and professor and chairman of the Department of Psychiatry and Behavioral Medicine, Winston-Salem, NC. "The most frequently reported sleep complaint among elderly patients is the inability to maintain sleep through the night. The data from this recent study of Lunesta are clinically relevant as they show that elderly patients treated with Lunesta demonstrated improvements in sleep maintenance."

Study data showed that Lunesta 2 mg was associated with a significantly (P <.05) reduced time to sleep onset, reduced wake time after sleep onset (WASO), increased sleep efficiency and increased total sleep time (TST). In this study, Lunesta was generally well tolerated with the most frequently reported adverse events being pain, dry mouth, dizziness, somnolence and unpleasant taste.

"This study is the largest-ever published, placebo-controlled, double-blind clinical trial of nightly administration of a sleep agent in elderly patients with chronic insomnia using both PSG and patient-reported measures," said McCall. "These data underscore the value of conducting future, longer-term studies of Lunesta in elderly patients suffering from chronic insomnia, and in those who experience insomnia due to co-existing conditions common to this population, such as depression or arthritis."

The results from this study were consistent with findings from a previously published, two-week trial in the journal SLEEP, which studied the administration of Lunesta 1 mg and 2 mg in elderly patients with insomnia outside of a sleep lab environment.1

To access the study published in Current Medical Research and Opinion, please visit: http://libra.publisher.ingentaconnect.com/content/libra/cmro /2006/00000022/00000009/art00002

(Due to the length of this URL, it may be necessary to copy and paste it into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)

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 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.

Important Safety Information

Lunesta is indicated for the treatment of insomnia. Lunesta works quickly and 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. Most sleep medicines carry some risk of dependency. Do not use sleep medicines for extended periods without first talking to your doctor. Please see your doctor if you experience unusual changes in thinking or behavior, or your 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.

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 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. Sepracor's corporate headquarters are located in Marlborough, Massachusetts.

Forward-Looking Statement

REFERENCE:
1. Scharf M, Erman M, Rosenberg R, et al. A two-week efficacy and safety study of eszopiclone in elderly patients with primary insomnia. SLEEP 2005;28:720-7

Lunesta is a registered trademark of Sepracor Inc. DSM-IV is a registered trademark of the American Psychiatric Association.


SOURCE: Sepracor Inc.

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