Ramelteon 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Accompanied by Difficulty Falling Asleep> - Transitional Survey From the Preceding Drug-use Survey -

Rozerem 8 mg Tablets Specified Drug-use Survey: <Long-term Survey on Insomnia Associated With Sleep-onset Difficulty > - Transitional Survey From the Preceding Drug-use Survey -

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02153086

Enrollment

236

Registered

2014-06-02

Start date

2011-03-31

Completion date

2014-06-30

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Keywords

Pharmacological therapy

Brief summary

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.

Detailed description

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.

Interventions

DRUGRamelteon

Ramelteon tablets 8 mg

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

-Participants 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

* Participants with contraindications to Rozerem Tablets. * Participants with previous history of hypersensitivity to ingredients in Rozerem Tablets. * Participants with severe liver dysfunction. * Participants taking fluvoxamine maleate

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Reporting One or More Adverse Drug Reactions	Baseline up to 12 months	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.

Secondary

Measure	Time frame	Description
Sleep Status: Total Sleep Time	Baseline, Week 4 and Month 12	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).
Sleep Status: Number of Awakenings	Baseline, Week 4 and Month 12	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).
Percentage of Participants Reported With Improvement on the Patient Global Impression (PGI) Scale for Sleep Onset	At Week 4, 52, and final assessment (up to 12 months)	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).
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Duration	At Week 4, 52, and final assessment (up to 12 months)	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).
Sleep Status: Sleep Onset Latency	Baseline, Week 4 and Month 12	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).
Percentage of Participants Reported With Improvement on the PGI Scale for Morning Awakening	At Week 4, 52, and final assessment (up to 12 months)	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).
Percentage of Participants Reported With Improvement on the PGI Scale for Remaining Tiredness in the Morning	At Week 4, 52, and final assessment (up to 12 months)	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).
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Somnolence	At Week 4, 52, and final assessment (up to 12 months)	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).
Percentage of Participants Reported With Improvement on the PGI Scale for Daytime Physical Condition/Function	At Week 4, 52, and final assessment (up to 12 months)	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).
Percentage of Participants Reported With Improvement on the PGI Scale for Sleep Quality	At Week 4, 52, and final assessment (up to 12 months)	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).

Countries

Japan

Participant flow

Recruitment details

Participants took part in the study at 2 investigative sites in Japan from 01 March 2011 to 30 June 2014.

Pre-assignment details

Participants with a historical diagnosis of insomnia which was associated with difficulty in falling asleep in daily clinical practice were enrolled in a single treatment group to receive ramelteon 8 milligram (mg).

Participants by arm

Arm	Count
Ramelteon 8 mg Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.	232
Total	232

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Not enrolled >=28 days and <=56 days	2
Overall Study	Other	2

Baseline characteristics

Characteristic	Ramelteon 8 mg
Age, Continuous	65.1 years STANDARD_DEVIATION 18.6
Breakdown of complications Allergic disease	23 participants
Breakdown of complications Diabetes mellitus	22 participants
Breakdown of complications Dyslipidaemia	57 participants
Breakdown of complications Heart or cerebrovascular disease	22 participants
Breakdown of complications Hypertension	86 participants
Breakdown of complications Mental disease	32 participants
Breakdown of complications Renal and urinary disorders	17 participants
Degree of sleep disorders Mild	72 participants
Degree of sleep disorders Moderate	130 participants
Degree of sleep disorders Severe	30 participants
Duration of insomnia >=3 to <5 years	14 participants
Duration of insomnia >=5 years	11 participants
Duration of insomnia Greater than equal to (>=) 1 year to <3 years	15 participants
Duration of insomnia Less than (<) 1 year	102 participants 2.71
Duration of insomnia Unknown	90 participants
Presence of complications Had Complications	193 participants
Presence of complications Had No Complications	39 participants
Sex: Female, Male Female	139 Participants
Sex: Female, Male Male	93 Participants
Type of sleep disorders (Major symptoms) Difficulty falling asleep	127 participants
Type of sleep disorders (Major symptoms) Difficulty getting sound sleep	16 participants
Type of sleep disorders (Major symptoms) Difficulty staying asleep	44 participants
Type of sleep disorders (Major symptoms) Early morning awakening	2 participants
Type of sleep disorders (Major symptoms) Unknown	43 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 232
serious Total, serious adverse events	0 / 232

Outcome results

Primary

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

Population: The safety analysis set was defined as all participants who were enrolled and completed the study.

Arm	Measure	Value (NUMBER)
Ramelteon 8 mg	Number of Participants Reporting One or More Adverse Drug Reactions	0 participants

Secondary

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).

Time frame: At Week 4, 52, and final assessment (up to 12 months)