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

Overview

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

Full Title of Study: “Investigation of the Safety and Efficacy of Long Term Administration of Eszopiclone in Insomnia Patients (Study LUN02T)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 30, 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Participants with insomnia
    • Participants with insomnia who will receive eszopiclone per approved label.

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of overall improvement
    • Time Frame: 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
  • Assessment of overall improvement
    • Time Frame: At month 6
    • 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

Secondary Measures

  • Number of participants with adverse events (AEs)
    • Time Frame: Up to 6 months

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eisai Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Akira Endo, Study Director, Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

Citations Reporting on Results

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

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