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To investigate the safety and efficacy of administration of eszopiclone for 6 months in insomnia participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with insomnia | Participants with insomnia who will receive eszopiclone per approved label. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 6 months |
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Inclusion Criteria:
1. Participants who have completed LUN01S and need to continue eszopiclone
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Participants who have completed Study LUN01S and need to continue eszopiclone
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| Name | Affiliation | Role |
|---|---|---|
| Akira Endo | Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Japanese Journal of Sleep Medicine 11: 81-94, 2017. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Tokyo |
| Japan |
| D001523 |
| Mental Disorders |
| D011725 |
| Pyridines |