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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02455271

Enrollment

438

Registered

2015-05-27

Start date

2012-10-01

Completion date

2015-12-22

Last updated

2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Insomnia

Brief summary

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

Interventions

DRUGEszopiclone

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of overall improvement	At month 3	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

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026