Ramelteon 8 mg Tablets Specified Drug-use Survey: - Transitional Survey From the Preceding Drug-use Survey -

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda

Criteria

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