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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 Oct 17, 2026, 8:24 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
Oct 2006 (Type not available)
Primary completion
Feb 2008 (Actual)
Completion
Feb 2008 (Actual)
Last update posted
Mar 14, 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 14, 2016 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00386334 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →