Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02452684

Enrollment

4876

Registered

2015-05-25

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 4 weeks in insomnia patients.

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. Insomnia participants who did not take eszopiclone before assessment 2. Participants who receive assessment by using sleep questionaries

Design outcomes

Primary

Measure	Time frame	Description
Assessment of overall improvement	Up to 4 weeks	Participants will be interviewed regarding sleep improvement at 4 weeks 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 4 weeks

Countries

Japan

Outcome results

None listed

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