A scientific study to check how much the drug Zolpidem tartrate is effective and safe in the patients of Insomnia (slip disorder) with Diabetes Mellitus
- Conditions
- Health Condition 1: G470- Insomnia
- Registration Number
- CTRI/2019/01/017332
- Lead Sponsor
- Dr Faraz Farishta
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy adult patients (both male and female) who are 18 to < 65 years of age.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method