Formulation and physicochemical evaluation of zolpidem sublingual film and comparative study of effect whit Zolpidem tablet in patient with chronic insomnia

Phase 3

Recruiting

• Conditions: Chronic insomnia.; Insomnia; G47.0

• Registration Number: IRCT20180120038450N3
• Lead Sponsor: Kermanshah University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 7 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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

History of allergy to zolpidem
Neurological and mental diseases
Pregnancy and lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Scores from the Pittsburgh and The Leeds Sleep Evaluation questionnaires. Timepoint: After taking the drug. Method of measurement: Score from answering the questionnaires.

Secondary Outcome Measures

Name	Time	Method
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.