---
title: Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients
nct_id: NCT02452684
overall_status: COMPLETED
sponsor: Eisai Co., Ltd.
study_type: OBSERVATIONAL
primary_condition: Insomnia
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02452684.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02452684"
ct_last_update_post_date: 2018-09-07
last_seen_at: "2026-05-12T06:41:51.884Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients

**Official Title:** Investigation of the Safety and Efficacy of Eszopiclone in Insomnia Patients (Study LUN01S)

**NCT ID:** [NCT02452684](https://clinicaltrials.gov/study/NCT02452684)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 4876
- **Lead Sponsor:** Eisai Co., Ltd.
- **Conditions:** Insomnia
- **Start Date:** 2012-10-01
- **Completion Date:** 2015-12-22
- **CT.gov Last Update:** 2018-09-07

## Brief Summary

To investigate the safety and efficacy of administration of eszopiclone for 4 weeks in insomnia patients.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

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

## Arms

- **Participants with insomnia** — Participants with insomnia who will receive eszopiclone, per approved label.

## Interventions

- **Eszopiclone** (DRUG) — 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.

## Primary Outcomes

- **Assessment of overall improvement** _(time frame: 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 Outcomes

- **Number of participants with adverse events (AEs)** _(time frame: Up to 4 weeks)_

## Locations (2)

- Osaka, Japan
- Tokyo, Japan

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `locations.|osaka||japan` — added _(2026-05-12)_
- `locations.|tokyo||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02452684.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02452684*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*