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

Takeda

Status: Completed

Conditions: Insomnia

Treatments: Drug: Ramelteon

Study type: Observational

Funder types: Industry

Identifiers

NCT02058992

JapicCTI-R150751 (Registry Identifier)

293-101

JapicCTI-132358 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 3,339 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

3,339 participants in 1 patient group

Ramelteon 8 mg administered orally once daily

Treatment:

Drug: Ramelteon