6-Month Chronic Efficacy & Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00352144
Recruitment Status : Completed
First Posted : July 14, 2006
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):

Brief Summary:
To evaluate the long-term efficacy of eszopiclone administered for up to 6 months in subjects with primary insomnia on subjective sleep measures, compared to placebo.

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: Eszopiclone Drug: Placebo Phase 3

Detailed Description:
This is a double blind, randomized (2:1; eszopiclone : placebo), placebo-controlled, multicenter, study of eszopiclone in subjects with primary insomnia. The study will involve up to 9 visits and subject participation will be approximately 224 days. After meeting all screening criteria, subjects will be randomized to either eszopiclone 3 mg QD or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 830 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Six-Month, Chronic Efficacy and Safety Study of Eszopiclone in Adult Subjects With Primary Insomnia: A Randomized Double-Blind, Placebo-Controlled Study
Study Start Date : October 2003
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Eszopiclone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
eszopiclone 3 mg tablet
Drug: Eszopiclone
Eszopiclone 3 mg
Other Names:
  • Lunesta
  • S-Zopiclone
Placebo Comparator: 2
Placebo tablet
Drug: Placebo
Placebo tablet

Primary Outcome Measures :
  1. Average of Subjective Sleep Latency [ Time Frame: Days -14, 1, 30, 60, 90, 120, 150, 180 ]

Secondary Outcome Measures :
  1. Average of Total Sleep Time (TST) and Wake Time After Sleep Onset (WASO) [ Time Frame: Days -14, 1, 30, 60, 90, 120, 150, 180 ]
  2. SF-36 [ Time Frame: Days 1, 30, 90, 180 ]
  3. Work Limitations Questionnaire (WLQ) [ Time Frame: Days 1, 30, 90, 180 ]
  4. Insomnia Severity Index (ISI) [ Time Frame: Days 1, 30, 90, 180 ]
  5. Fatigue Severity Scale (FSS) [ Time Frame: Days 1, 30, 90, 180 ]
  6. Epworth Sleepiness Scale (ESS) [ Time Frame: Days 1, 30, 60, 90, 120, 150, 180 ]
  7. Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ) [ Time Frame: Day 180 ]
  8. Healthcare Utilization Questionnaire (HUQ) [ Time Frame: Days 1, 30, 60, 90, 120, 150, 180 ]

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Ages Eligible for Study:   21 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Subject meets DSM-IV criteria for primary insomnia and reports sleeping no more than 6.5 hours per night and/or taking more than 30 minutes each night to fall asleep for at least one month prior to screening.
  • Male and female subjects must be between 21 and 64 years of age, inclusive, at the time of consent.
  • Female subjects of childbearing potential must sign the Women of Childbearing Potential Addendum to the informed consent form. Females considered not of childbearing potential must be surgically sterile or greater than one-year post menopausal, defined as a complete cessation of menstruation for at least one year.
  • Subject must be in general good health, based on screening physical examination (including brief neurological examination), medical history, 12-lead ECG, and clinical laboratory values (hematology, serum chemistry and urinalysis).

Exclusion Criteria

  • Subject has any clinically significant unstable medical abnormality, chronic disease, or a history of a clinically significant abnormality of the cardiovascular, respiratory, hepatic, or renal systems.
  • Subject has a history of cancer within the past 5 years, or current malignancy except for non melanomatous skin cancer.
  • Subject has a psychiatric diagnosis with psychosis, dementia or delirium. Subjects with Sexual and Gender Identity Disorders or other non-psychotic disorders will be considered on a case-by-case basis.
  • Subject has one of the following Personality Disorders: schizotypal, schizoid, or borderline personality disorder.
  • Subject has difficulties in sleep initiation or maintenance associated with known medical diagnosis (e.g. sleep apnea, restless leg syndrome (RLS), or periodic leg movement syndrome (PLMS), or has any condition that has or may affect sleep (e.g., chronic pain, BPH, etc.).
  • Subject has participated in a previous eszopiclone clinical trial.
  • Subject has a known sensitivity to racemic zopiclone, any benzodiazepine, any sedative hypnotic, any substance that is contained in the formulation, or has been hospitalized for any allergic conditions (e.g. recurrent dermatitis, drug hypersensitivity, drug allergy, etc.).
  • Subject has history of substance abuse in the past 10 years or substance dependence at any time or positive urine drug test at screening .
  • Subject tests positive at screening for hepatitis B surface antigen, hepatitis C antibody or has a history of a positive result.
  • Subject is known to be seropositive for HIV.
  • Female subjects who are pregnant, lactating or within 6 months post partum.
  • Subject self-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 has taken any psychotropic medications or other medications known to affect sleep within the 3 days prior to screening visit or is anticipated to need any of these types of medications during double-blind treatment .
  • Subject has participated in any investigational study within 30 days prior to screening.
  • Subject has taken herbal supplements, purported to have central nervous system effects,(tablets, powders, extracts or tinctures) or combination products with herbs or melatonin within 14 days prior to screening or St. John's Wort within 30 days prior to screening.
  • Subject is a rotating or third/night shift worker.
  • Subject is a staff member or relative of a staff member.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00352144

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Sponsors and Collaborators

Responsible Party: Sunovion Identifier: NCT00352144     History of Changes
Other Study ID Numbers: 190-050
First Posted: July 14, 2006    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs