The purpose of this study is to investigate the safety and efficacy of ramelteon (Rozerem) when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia.
This is a drug use surveillance planned to examine the safety and efficacy of ramelteon tablets when used in the routine clinical setting in patients with sleep-onset difficulty associated with insomnia (planned sample size, 3000) The usual adult dosage is 8 mg of ramelteon administered orally once daily at bedtime.
Study Type
OBSERVATIONAL
Enrollment
3,339
Ramelteon 8 mg tablets
Number of Participants Reporting One or More Adverse Drug Reactions
Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE 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.
Time frame: Baseline up to 6 weeks
Number of Participants Reporting One or More Serious Adverse Drug Reactions
Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline up to 6 weeks
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.
Time frame: Baseline and Week 4
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.
Time frame: Baseline and Week 4
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.
Time frame: Baseline and Week 4
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Percentage of Participants Who Responded With Improvement on the Patient Global Impression (PGI) Scale at Week 4
PGI is a participant rated instrument to measure participant's change in overall status on a 7-point scale. 7 items on scale include sleep onset, sleep time, sleep quality, morning awakening, morning tiredness, daytime somnolence, and daytime physical condition/function. Participants provide their response on a PGI questionnaire. The results of survey using the PGI questionnaire was scored, summarized and assessed. 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 for sleep onset,time, quality; morning awakening, tiredness and daytime sleepiness, physical condition.
Time frame: Week 4