Insomnia
Conditions
Interventions
None listed
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.A patient with a diagnosis of insomnia with difficulty falling asleep who has been started on treatment with oral Ramelteon 8 mg/day 2.A patient who has answered the Insomnia Severity Index (ISI) questionnaire and the health-related QOL scale Short Form-8 (SF-8) in routine clinical settings before the start of Ramelteon therapy 3.A patient who has given consent to the use of clinical information for the study at 20 years of age or older
Exclusion criteria
Exclusion criteria: 1.A patient who has received Ramelteon within 4 weeks before the start of oral ramelteon therapy 2.A patient with dementia 3.A patient with a history of hypersensitivity to Ramelteon 4.A patient with severe hepatic impairment 5.A patient with a history of drug abuse 6.A patient with psychiatric disease in an unstable condition 7.A patient who, in the opinion of the principal investigator or co-investigator, is not appropriate for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and patient background factors | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Relationship between the change in the Physical Component Summary (PCS-8) score or Mental Component Summary (MCS-8) score, which are QOL variables measured by the health-related QOL scale Short Form-8 (SF-8), and patient background factors ?Relationship between the change in insomnia severity measured by the Insomnia Severity Index (ISI) and the change in the QOL variable measured by the health-related QOL scale Short Form-8 (SF-8) | — |
Countries
Japan
Outcome results
None listed