Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Tab Zolpidem: Group B will receive a 5mg tablet Zolpidem 30 minutes before bedtime, daily. A similar protocol for dose titration will be followed. The maximum dose of zolpidem used in
Sponsors
Sir Ganga Ram Hospital
Eligibility
Inclusion criteria
Inclusion criteria: male and female patients of 18-65 years
Exclusion criteria
Exclusion criteria: history of hypersensitivity or allergic reaction to melatonin or zolpidem, patients with reported severe psychiatric illness,Having a NCCN Distress Thermometer score of more than 7, Documented present history of complex sleep behaviors,Documented history of substance dependence, Patients with history of obstructive sleep apnea, Patients taking concomitant opioid medication,Patients having comorbidities such as autoimmune diseases, bleeding disorders, dementia, severe decompensated hepatic failure and chronic obstructive pulmonary disease, Pregnant or lactating patients and Failure to obtain informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage change in insomnia severity as assessed by Insomnia Severity Index from baseline to 2,4 and 6 weeksTimepoint: 2,4 and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage change in Improvement in sleep quality and daytime functioning as assessed by Pittsburgh Sleep Quality Index from baseline to 6 weeksTimepoint: 6 weeks;2.Incidence of adverse events like drowsiness,amnesia, hallucinations,headache, falls or imbalance,vivid dreams and complex sleep behaviors assessed using the Common Terminology Criteria for Adverse Events v5.0 at 2, 4 and 6 weeksTimepoint: 2,4 and 6 weeks | — |
Countries
India
Contacts
Public ContactDR BIMLA SHARMA
Sir Ganga Ram Hospital
Outcome results
None listed