Study of Eszopiclone Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause/Menopause

Inclusion Criteria

• Subject must understand the purpose of the study and be willing to adhere to the study schedule and procedures described in this protocol.
• Subject must be between the ages of 40 and 60 years, inclusive, on the day of signing consent.
• Subject must have perimenopausal or menopausal signs and symptoms.
• Subject must report SL of >45 minutes and <6 hours of TST at least three times a week over the previous month and symptoms of insomnia must post date onset of perimenopausal or menopausal symptoms.
• Subject's physical exam must show no clinically significant abnormal findings (other than insomnia and menopause symptoms) at screening.

Exclusion Criteria

• Subject has history of circadian rhythm disorder, or travels across >3 time zones on a regular basis.
• Female subject is pregnant, lactating or within 6-months post partum.
• Subject has a history of drug or alcohol abuse or dependence in the past 2 years or positive urine drug test at screening .
• Subject has unstable medical abnormality, or unstable chronic disease; or history of significant cardiac, renal, or hepatic disease, seizure disorder, or current or past acute suicidal tendencies.
• Subject has participated in any investigational drug study within 30 days prior to screening or plans to participate in another investigational drug study during participation in this study.
• Subject is taking hormone replacement therapy or an hormonal contraceptive, and has not been on a stable dose for a minimum of 60 days prior to study start.
• Subject is known to be seropositive for HIV.
• Subject has a disorder or history of a condition (e.g., malabsorption, gastrointestinal surgery) that may interfere with drug absorption distribution, metabolism, or excretion.
• Subject has a history of malignancy within 5 years, or current malignancy, except for non-melanoma skin cancer.
• Subject has a diagnosis of any psychiatric disorder as identified by a psychiatric screening questionnaire.
• Subject has any primary diagnosis (personality disorder or mental retardation) that would impact the investigator's ability to evaluate the safety or efficacy of the study medication.
• Subject has difficulties in sleep initiation or maintenance associated with other known primary sleep disorders [e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS)], or has any condition that may affect sleep (e.g., chronic pain, urinary incontinence, etc.).
• Subject has used any drugs known or suspected to affect hepatic or renal clearance capacity within a period of 30 days prior to screening.
• Subject reports consumption of more than two alcoholic beverages daily, 14 or more alcoholic beverages weekly, or five or more alcoholic beverages on any given day.
• Subject is a rotating or third/night shift worker.
• Subject is a staff member or relative of a staff member.
• Subject is experiencing symptoms of premature menopause or surgical menopause.
• Subject has discontinued hormone replacement therapy or a hormonal contraceptive, and has not been off treatment for a minimum of 60 days prior to study start.
• Subject has been on hormone replacement therapy or hormonal contraceptives for greater then one year.