Ramelteon Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

Rozerem Tablets 8mg Drug Use Surveillance: Survey on Insomnia Associated With Sleep-onset Difficulty

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Drug: Ramelteon

Detailed Description

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 (Actual): 3339

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Insomnia

Description

Inclusion Criteria:

1. Sleep-onset difficulty associated with insomnia

Exclusion Criteria:

1. Patients with previous history of hypersensitivity to an ingredient of Rozerem Tablets
2. Patients with severe liver dysfunction
3. Patients taking fluvoxamine maleate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ramelteon 8 mg administered orally once daily	Drug: Ramelteon; Ramelteon 8 mg tablets; Other Names: Rozerem

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and Week 4
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.	Week 4

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 7, 2014
• First Posted (Estimate): February 11, 2014

Study Record Updates

• Last Update Posted (Estimate): July 14, 2016
• Last Update Submitted That Met QC Criteria: June 2, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 293-101; JapicCTI-132358 (Registry Identifier: JapicCTI); JapicCTI-R150751 (Registry Identifier: JapicCTI)