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.
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.
Study Type
OBSERVATIONAL
Enrollment
236
Ramelteon tablets 8 mg
Unnamed facility
Osaka, Japan
Unnamed facility
Tokyo, Japan
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.
Time frame: Baseline up to 12 months
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: At Week 4, 52, and final assessment (up to 12 months)