Health Condition 1: 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 Faraz Farishta
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) for 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 Diabetes Mellitus on treatment with anti diabetic agents. (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 enrolment. 2. Shift work or requirement for a regular change in sleep schedule by at least six hours within 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. History of current Hypertension. 5. Current alcohol or drug abuse. 6. Patients viewed by the investigator as not being able to complete the study. 7. History of obstructive sleep apnoea or restless leg syndrome 8. History of myasthenia gravis 9. History of hepatic insufficiency 10. History of respiratory depression 11. Patients with a known history of hypersensitivity to Zolpidem tartrate or any of the inactive ingredients 12. The presence of any untreated or uncompensated clinically significant renal, endocrine, gastrointestinal, hepatic, respiratory, cardiovascular, other neurologic, hematologic, oncologic, immunologic, cerebro vascular disease or malignancy. 13. Patients with history of severe cardiac, hepatic, neurological and renal diseases within 6 months prior of screening. 14. Pregnant or breastfeeding. 15. Patient having participated in a clinical trial in the month before. 16. Patients with history of bipolar disorder, psychosis, major depression, unstable anxiety disorders/panic attacks. 17. Patients with cognitive impairment 18. Elderly patients having symptoms of urinary obstructions 19. Patients with symptoms of chronic/ incapacitating pain 20. Patients with diabetic neuropathy 21. Patients with any other serious disease or condition at screening that might affect the normal sleep pattern. 22. Known history of other sleep disorders (i.e. narcolepsy; hypersomnia; parasomnias such as sleep walking, night terrors, recurring nightmares; circadian rhythm sleep disorder) 23. Patients who are taking other CNS depressants drugs like antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, narcotic analgesics, antiepileptic drugs, anaesthetics and sedative antihistamines or CYP 3A4 or CYP 1A2 inducers or inhibitors.
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 HbA1c ScoreTimepoint: Baseline visit to Day 90 ;To measure the change in HRQoL ScoreTimepoint: Baseline visit to Day 21 Visit | — |
Countries
India
Contacts
Public ContactDr Faraz Farishta
F S Endocrinology & Diabetic Centers
Outcome results
None listed