Rozerem 8 mg Tablets specified drug-use survey: <Long-term survey on associated with sleep-onset difficulty > - Transitional survey from the preceding drug-use survey
Not Applicable
- Conditions
- Insomnia
- Registration Number
- JPRN-jRCT1080222454
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients 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
Patients with contraindications to Rozerem Tablets
[1] Patients with previous history of hypersensitivity to ingredients in Rozerem Tablets
[2] Patients with severe liver dysfunction
[3] Patients taking fluvoxamine maleate
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of adverse drug reactions<br>Primary timeframeFor 6 months (for 1 year in patients for whom follow-up can be performed)<br>The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with administration of ramelteon whether or not it was considered related to treatment. Among these, events that are considered as having a causal relationship with ramelteon are defined as adverse drug reactions.
- Secondary Outcome Measures
Name Time Method Changes from baseline in sleep status (sleep latency, total sleep time, and number of awakenings) and patient global impression (PGI) score<br>Secondary timeframeFrom baseline to 6 months of treatment (For 1 year in patients for whom follow-up can be performed)<br>(1) Changes from baseline in sleep status (sleep latency, total sleep time, and number of awakenings) from the start of the surveillance will be tabulated and assessed.<br>(2) Results of surveys using the PGI questionnaire will be scored, and scores for 7 items (sleep onset, sleep duration, sleep quality, morning awakening, remaining tiredness in the morning, daytime somnolence, and daytime physical condition/function) will be tabulated and assessed.