Overview

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

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Takeda
Criteria
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