Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients

Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)

To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Eszopiclone

• Study Type: Observational
• Enrollment (Actual): 438

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants who have completed Study LUN01S and need to continue eszopiclone

Description

Inclusion Criteria:

1. Participants who have completed LUN01S and need to continue eszopiclone

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with insomnia; Participants with insomnia who will receive eszopiclone per approved label.	Drug: Eszopiclone; The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.; Other Names: EZOP; Lunesta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of overall improvement	Participants will be interviewed regarding sleep improvement at 3 months after first dose or discontinuation, relative to predose, and select the appropriate answer of: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible	At month 3
Assessment of overall improvement	Participants will be interviewed regarding sleep improvement at 6 months after first dose or discontinuation, relative to predose, and select the appropriate answer: 1. Improved 2. Unchanged 3. Worse 4. Indiscernible	At month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to 6 months

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Akira Endo, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

Publications and helpful links

General Publications

• Japanese Journal of Sleep Medicine 11: 81-94, 2017.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): March 30, 2015
• Study Completion (Actual): December 22, 2015

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 22, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Insomnia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives; Eszopiclone
• Other Study ID Numbers: LUN02T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No