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Completed Phase 4 Interventional Results available

A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia

ClinicalTrials.gov ID: NCT00386334

Public ClinicalTrials.gov record NCT00386334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 5:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly Subjects With Primary Chronic Insomnia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To evaluate the long-term safety and efficacy of eszopiclone administered for 12 weeks in elderly subjects with primary chronic insomnia.Administration of eszopiclone 2 mg daily at bedtime for 12 weeks in elderly subjects with a diagnosis of primary chronic insomnia will be safe and well tolerated, improve subjective sleep measures, improve measures of Quality of Life and next day insomnia symptoms, and have no significant withdrawal central nervous system adverse events or rebound insomnia.

Study identification

NCT ID
NCT00386334
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Sumitomo Pharma America, Inc.
Industry
Enrollment
388 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
65 Years to 85 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2006
Primary completion
Jan 31, 2008
Completion
Jan 31, 2008
Last update posted
Mar 13, 2016

2006 – 2008

United States locations

U.S. sites
82
U.S. states
27
U.S. cities
72
Facility City State ZIP Site status
Not listed Birmingham Alabama 35226
Not listed Chandler Arizona 85225
Not listed Glendale Arizona 85306
Not listed Tucson Arizona 85712
Not listed Anaheim California 92801
Not listed Irvine California 92618
Not listed La Mesa California 91942
Not listed Los Angeles California 90024
Not listed San Diego California 92108
Not listed San Diego California 92121
Not listed San Diego California 92123
Not listed Colorado Springs Colorado 80918
Not listed Denver Colorado 80212
Not listed Atlanta Florida 30342
Not listed Clearwater Florida 33765
Not listed Coral Springs Florida 33065
Not listed Delray Beach Florida 33458
Not listed Fort Myers Florida 33912
Not listed Gables Florida 33134
Not listed Jupiter Florida 33458
Not listed Maitland Florida 32751
Not listed Naples Florida 34110
Not listed Orlando Florida 32806
Not listed Pembroke Pines Florida 33024
Not listed Pinellas Park Florida 33781
Not listed Sarasota Florida 34238
Not listed St. Petersburg Florida 33707
Not listed St. Petersburg Florida 33709
Not listed Vero Beach Florida 32960
Not listed West Palm Beach Florida 33407
Not listed Stockbridge Georgia 30281
Not listed Honolulu Hawaii 96814
Not listed Chicago Illinois 60610
Not listed Chicago Illinois 60634
Not listed Vernon Hills Illinois 60061
Not listed Evansville Indiana 47714
Not listed Overland Park Kansas 66212
Not listed Prairie Village Kansas 66206
Not listed Crestview Hills Kentucky 41017
Not listed Lexington Kentucky 40509
Not listed Baton Rouge Louisiana 70809
Not listed Baltimore Maryland 21208
Not listed Boston Massachusetts 02135
Not listed Braintree Massachusetts 02184
Not listed Newton Massachusetts 02459
Not listed Florissant Missouri 63031
Not listed Hamilton New Jersey 08690
Not listed Albuquerque New Mexico 87106
Not listed Brooklyn New York 11235
Not listed Mineola New York 11501
Not listed New York New York 10021
Not listed New York New York 10023
Not listed Rochester New York 14609
Not listed Cary North Carolina 27540
Not listed Durham North Carolina 27710
Not listed Hickory North Carolina 28601
Not listed New Bern North Carolina 28562
Not listed Winston-Salem North Carolina 27157
Not listed Beachwood Ohio 44122
Not listed Cincinnati Ohio 45206
Not listed Cleveland Ohio 44122
Not listed Dayton Ohio 45408
Not listed Mogadore Ohio 44260
Not listed Oklahoma City Oklahoma 73103
Not listed Oklahoma City Oklahoma 73112
Not listed Oklahoma City Oklahoma 73118
Not listed Allentown Pennsylvania 18104
Not listed Duncansville Pennsylvania 16635
Not listed Scotland Pennsylvania 17254
Not listed Warwick Rhode Island 02886
Anderson Pharmaceutical Research Anderson South Carolina 29521
Not listed Anderson South Carolina 29621
Not listed Simpsonville South Carolina 29681
Not listed Dallas Texas 75231
Not listed Houston Texas 77024
Not listed San Antonio Texas 78205
Not listed San Antonio Texas 78229
Not listed San Antonio Texas 78238
Not listed Wichita Falls Texas 76309
Not listed Fairfax Virginia 22030
Not listed Richmond Virginia 23229
Not listed Spokane Washington 99204

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00386334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 13, 2016 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00386334 live on ClinicalTrials.gov.

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