Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Zolpidem Tartrate (Zolfesh) 10 mg: Zolpidem Tartrate Tablet (Zolfesh) 10mg is taken orally with water daily immediately before bedtime with at least 7-8 hours remaining before the plann
Sponsors
Dr Mahesh Gowda
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients above 18 years of age. 2. Patients with HAM A score of at least 18) with known history of insomnia (ISI =7) not on pharmacotherapy 3. Patients on psychotropics, after a washout period equivalent to four half-lives of the drug 4. The patient has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure 5. Patients willing to fill patient diaries, have good compliance, and willing to comply with the study procedure and requirements 6. Patients with no mental disease and are not using psychoactive medications 7. Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigator’s discretion, throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at screening visit.
Exclusion criteria
Exclusion criteria: 1. Patients with sleep disorder such as narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome or obstructive sleep apnea syndrome or with severe, life-threatening chronic sleep disorders, hepatic failure, thyroid dysfunction, cardiovascular diseases, myasthenia gravis, respiratory insufficiency, anaphylaxis and angioedema 2. Patients with severe psychiatric disorder or a history of major psychiatric disorder (e.g. depression, autism, suicide attempt, bipolar disorder, schizophrenia etc.) or psychomotor impairment 3. Patients taking sleep medications, psychotherapy or acupuncture for insomnia within a month prior to enrolment into the study 4. Patients with a history of drug addiction, drug or alcohol abuse or likely to concomitantly consume alcoholic beverages more than 3 times/week 5. Patients with a progressive medical illness (e.g., cancer, dementia) directly related to the onset and course of insomnia 6. Patients who take medications known to alter sleep (e.g., Alpha-blockers, Betablockers, Corticosteroids, SSRI antidepressants, ACE inhibitors, ARBs Cholinesterase inhibitors, Histamine 1 antagonists, Glucosamine/chondroitin, and Statins) 7. Patients with an evidence of sleep-disordered breathing or sleep-related movement disorder 8. Patients with nightshift work or irregular sleep schedule 9. Patients participated in any investigational drug trial within 4 weeks prior to enrolment into the study 10. Patients with hypersensitivity to zolpidem tartrate or any of the inactive ingredients 11. Patients who are not willing to follow study procedures and have poor treatment compliance 12. Chronic user of benzodiazepines as this may cause tolerance to zolpidem 13. Patients with any other conditions or diseases that investigator considers it as inappropriate to enter the study as per prescribing information. 14. Female patients who are pregnant, lactating or intend to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effectiveness of zolpidem tartrate combined with cognitive behavioral therapy (CBT) versus CBT alone in terms of reduction in Insomnia Severity Index (ISI) total score from baseline to follow up visit and End of study visit in patients with insomnia associated with comorbid anxiety.Timepoint: At baseline visit(Day 0),week-4 and week-8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the improvement in symptoms of anxiety from baseline to follow up visit and End of study visit in group A versus group B 2. To assess health-related quality of life (HRQOL) from baseline to follow up visit and End of study visit in group A versus group B 3. To evaluate the safety and tolerability of zolpidem tartrate in patients with insomnia associated with comorbid anxietyTimepoint: 1. Baseline visit(day 0),week-4 and week-8 2. Baseline visit(day 0),week-4 and week-8 3. Baseline visit(day 0),week-4 and week-8 | — |
Countries
India
Contacts
Public ContactMr Vairamuthu Ammaiyappan
Spandana Nursing Home
Outcome results
None listed