CompletedNot Applicable

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 -

Japan236 participantsStarted 2011-03

Plain-language 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.

Who can participate

SexALL

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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

What they're measuring

Number of Participants Reporting One or More Adverse Drug Reactions

Timeframe: Baseline up to 12 months

Trial details

NCT IDNCT02153086

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-06

Results submitted2016-08-17

View on ClinicalTrials.gov More Insomnia trials