Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Lemborexant: Competitive antagonist of both orexin receptors, OX1R and OX2R.
A) Dose: Lemborexant film coated tablets 5mg and Lemborexant film coated tablets 10mg.
B) Frequency: Admin
Sponsors
Eisai Pharmaceuticals India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 -65 years old (both inclusive) at the time of informed consent. 2. A clinical diagnosis of insomnia, as determined by the investigator 3. The decision to prescribe lemborexant for the patient has been made independently from the study participation.
Exclusion criteria
Exclusion criteria: 1. Currently enrolled in another clinical study 2. Previously discontinued lemborexant treatment for any reason 3. Previously participated in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of TEAEs and serious adverse events (SAEs), discontinuations due to AEs, duration of treatment and dosage at time of AE.Timepoint: Screening, Month 1, Month 3, Month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| The score on the PGI I questionnaire at 1, 3, and 6 months after treatment, discontinuations due to lack of efficacy, duration of treatment, and dosage.Timepoint: Screening, Month 1, Month 3, Month 6 | — |
Countries
India
Contacts
Public ContactDr Balaji Patil
Eisai Pharmaceuticals India Pvt. Ltd.
Outcome results
None listed