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 -

Takeda

Status: Completed

Conditions: Insomnia

Treatments: Drug: Ramelteon

Study type: Observational

Funder types: Industry

Identifiers

NCT02153086

293-011

Details and patient eligibility

About

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.

Full description

This survey was designed 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.The usual dosage for adults is 8 mg of ramelteon administered orally once daily at bedtime.

Enrollment: 236 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

236 participants in 1 patient group

Ramelteon 8 mg Tablets

Treatment:

Drug: Ramelteon