Insomnia
Conditions
Interventions
investigational material(s)
Generic name etc : Rozerem 8 mg Tablets (ramelteon)
INN of investigational material :
Therapeutic category code : 119 Other agents affecting central nervous system
Dosage
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse drug reactions Primary timeframeFor 6 months (for 1 year in patients for whom follow-up can be performed) 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
| Measure | Time frame |
|---|---|
| Changes from baseline in sleep status (sleep latency, total sleep time, and number of awakenings) and patient global impression (PGI) score Secondary timeframeFrom baseline to 6 months of treatment (For 1 year in patients for whom follow-up can be performed) (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. (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. | — |
Outcome results
None listed