Health Condition 1: null- Insomnia
Conditions
Interventions
Intervention1: Ramelteon: 8 mg once daily for 4 weeks
Control Intervention1: Zolpidem: 10 mg once daily
Control Intervention2: Zolpidem: 10 mg once daily for 4 weeks
Sponsors
Sri Aurobindo Medical College Postgraduate Institute
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex, aged 18 to 65 years, suffering from insomnia. Primary or secondary insomnia with anxiety disorder or depression(diagnosed by psychiatrist) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSMÂ5). Ramelteon / Zolpidem prescribed (by psychiatrist). Written informed consent.
Exclusion criteria
Exclusion criteria: Patients with hypersensitivity to ramelteon, melatonin or zolpidem. Patients having sleep schedule changes required by employment e.g., shift workers. Patients with major depressive, psychotic or bipolar disorder with significant suicide risk. Patients with substance dependence/ abuse. Patients receiving any medication known to affect sleep. Clinically significant deviations from normal in medical history (apart from insomnia and psychiatric comorbid conditions such as anxiety disorders or depression), vital signs, physical examination, and laboratory evaluations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity IndexTimepoint: 2 and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Rating Scale for Depression Hamilton Rating Scale for AnxietyTimepoint: 2 and 4 weeks | — |
Countries
India
Contacts
Public ContactDr Ashutosh Tiwari
Sri Aurobindo Medical College and Postgraduate Institute
Outcome results
None listed