Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: G470- Insomnia
Conditions
Interventions
Intervention1: Zolpidem Tartrate: Zolpidem is indicated for the short-term treatment of insomnia. The treatment should be taken
in a single intake and not be re-administered during the same night. The
Sponsors
Dr Rajiv D Karnik
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy adult patients (both male and female) who are 18 to 2. Must experience sleep disturbances (difficulty in sleep initiation or middle of the night awakening or early morning awakening or poor quality of sleep) at least 3 nights/week, based on historical data. 3. Insomnia Severity Index score of >=8 at screening 4. Patients with a clinical diagnosis of Hypertension (at least one year prior to screening). 5. Patient willing to sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Currently using prescription and non-prescription sedative drugs given for more than 2 days for the purpose of sleep disturbances or to relieve jet lag with the last 28 days proceeding to enrollment. 2. Shift work or requirement for a regular change in sleep schedule by at least six hours with in the previous 28 days. 3. Evidence of any medical condition as revealed by history, physical examination or laboratory assessment which may interfere with administration or assessment of study medication 4. Current alcohol or drug abuse 5. Patients viewed by the investigator as not being able to complete the study. 6. History of obstructive sleep apnoea or restless leg syndrome. 7. History of myasthenia gravis. 8. History of hepatic insufficiency. 9. History of respiratory depression. 10. Patients with a known history of hypersensitivity to Zolpidem tartrate or any of the inactive ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the change in Insomnia severity index (ISI) ScoreTimepoint: Baseline visit to Day 21 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| To measure the change in HRQoL ScoreTimepoint: Baseline visit to Day 21 visit | — |
Countries
India
Contacts
Public ContactDr Rajiv D Karnik
Dr.Karniks Cardiac Clinic
Outcome results
None listed