Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -

Study Overview
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Brief Summary
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The purpose of this survey is to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.

Detailed Description
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This survey was designed to examine the safety and efficacy of long-term use of ramelteon tablets (Rozerem 8 mg Tablets) in participants with difficulty falling asleep associated with insomnia in daily medical practice.The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.

Official Title
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Rozerem 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Associated With Sleep-onset Difficulty > - Transitional Survey From the Preceding Drug-use Survey -

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Ramelteon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Participants with difficulty falling asleep associated with insomnia who have completed a 4-week follow-up in the preceding drug use surveillance and are able to receive continuous administration of Rozerem Tablets Exclusion Criteria: Participants with contraindications to Rozerem Tablets. Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets. Participants with severe liver dysfunction. Participants taking fluvoxamine maleate
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ramelteon 8 mg Tablets<br> | Drug: Ramelteon<br>* Ramelteon tablets 8 mg<br>* Other names: Rozerem 8 mg Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting One or More Adverse Drug Reactions | Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. | Baseline up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Status: Sleep Onset Latency | Sleep status was determined by measuring the sleep onset latency, defined as the length of time taken from lying down for the night until sleep onset. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12). | Baseline, Week 4 and Month 12 | 
| Sleep Status: Total Sleep Time | Sleep status was determined by measuring the total sleep time, defined as the amount of actual sleep time during a sleep episode. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12). | Baseline, Week 4 and Month 12 | 
| Sleep Status: Number of Awakenings | Sleep status of participants was assessed and summarized by calculating the number of times participants had awaken from the time of start of the investigation. The data was assessed at baseline, Week 4 and final visit (last visit for a participant in the study, up to Month 12). | Baseline, Week 4 and Month 12 | 
| Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset | Sleep onset was defined as the transition from wakefulness into sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 
| Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration | Sleep duration was defined as the total amount of sleep obtained. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 
| Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality | Sleep quality was defined as participants satisfaction of the sleep experience, integrating aspects of sleep initiation, sleep maintenance, sleep quantity, and refreshment upon awakening. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 
| Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening | Morning awakening was defined as the return to the awaked state from any non-rapid eye movement (NREM) to rapid eye movement (REM) sleep stages in the morning. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 
| Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning | Remaining tiredness in the morning was defined as an experience of fatigue after complete or adequate sleep duration. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 
| Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence | Daytime somnolence was defined as excessive daytime sleepiness (EDS), characterized by general lack of energy, even after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 
| Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function | Daytime physical condition/function was defined as general condition of participant throughout the day after adequate or prolonged night time sleep. PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. Participants provide their response on a PGI questionnaire. Total score range from 1 (very much improved) to 7 (very much worse). Percentage of participants with improvement rated as much better or a little better were reported. The data was assessed at Week 4, Week 52 and final visit (follow up visit up to Month 12). | At Week 4, 52, and final assessment (up to 12 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacological therapy