Chronic insomnia. Insomnia
Conditions
Interventions
Intervention 1: Intervention group: In this study, zolpidem is used as a sublingual film with polyvinyl alcohol and beta cyclodextrin polymers. The film contains 5 mg of zolpidem sublingually. Each pa
Sponsors
Kermanshah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 64 Years
Inclusion criteria
Inclusion criteria: 20_64 years old Difficulty falling asleep, persistent sleep, or poor quality sleep No drug addiction in the last 12 months Do not smoke more than 10 cigarettes a day or equivalent amounts of cocaine Do not consume more than 40 grams of alcohol per day Do not consume more than 6 glasses of caffeinated beverages Not getting pregnant or breastfeeding or trying to conceive Do not take any medication or supplement that affects the patient's sleep or wakefulness for one week before the screening BMI 18_30
Exclusion criteria
Exclusion criteria: History of allergy to zolpidem Neurological and mental diseases Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores from the Pittsburgh and The Leeds Sleep Evaluation questionnaires. Timepoint: After taking the drug. Method of measurement: Score from answering the questionnaires. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to start sleeping. Timepoint: After taking the drug. Method of measurement: Answer the questionnaire questions.;Duration of sleep. Timepoint: After taking the drug. Method of measurement: Answer the questionnaire questions. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHadis Mansouri
Kermanshah University of Medical Sciences
Outcome results
None listed