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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3339 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ramelteon 8 mg administered orally once daily

Ramelteon

Intervention Type DRUG

Ramelteon 8 mg tablets

Interventions

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Ramelteon

Ramelteon 8 mg tablets

Intervention Type DRUG

Other Intervention Names

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Rozerem

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No