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Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

This study has been completed.
Information provided by (Responsible Party):
Sunovion Identifier:
First received: October 6, 2005
Last updated: February 21, 2012
Last verified: February 2012
To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

Condition Intervention Phase
Insomnia Generalized Anxiety Disorder Drug: Eszopiclone (Lunesta) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Efficacy of Eszopiclone 3 mg as Adjunctive Therapy in Subjects With Insomnia Related to Generalized Anxiety Disorder.

Resource links provided by NLM:

Further study details as provided by Sunovion:

Primary Outcome Measures:
  • The change from baseline in subjective sleep latency averaged over the double-blind treatment period. [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Change from baseline in subjective total sleep time averaged over the double blind treatment period. [ Time Frame: 8 weeks ]

Enrollment: 420
Study Start Date: June 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Escitalopram oxalate 10 mg at bedtime
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta
Active Comparator: 2
Eszopiclone 3 mg at bedtime
Drug: Eszopiclone (Lunesta)
Escitalopram oxalate 10 mg at bedtime; Eszopiclone 3 mg at bedtime
Other Name: Lunesta

Detailed Description:
An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. 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.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • Subjects, between the ages of 18 and 64 years inclusive
  • Subjects with Generalized Anxiety Disorder (GAD)
  • Subjects with insomnia related to GAD.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00235508

  Show 64 Study Locations
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sunovion Identifier: NCT00235508     History of Changes
Other Study ID Numbers: 190-902
Study First Received: October 6, 2005
Last Updated: February 21, 2012

Keywords provided by Sunovion:
Generalized Anxiety Disorder

Additional relevant MeSH terms:
Anxiety Disorders
Sleep Initiation and Maintenance Disorders
Pathologic Processes
Mental Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on August 18, 2017