Primary Objective: To estimate the range of improvement of NOVANUIT® triple action on sleep quality global score. Secondary Objectives: * To estimate the range of improvement of NOVANUIT® triple action on following parameters: time for getting asleep, sleep time, number of nocturnal awakening, number of nightmares, sleep quality (score from 0 to 10), and mean tiredness during the day (score from 0 to 10). * To estimate persistency of NOVANUIT® triple action effects after end of study product consumption. * To assess dependency to NOVANUIT® triple action after study product cessation. * To assess tolerance of NOVANUIT® triple action during the study.
Study participation duration for each participant will be 4 weeks including a 2-week treatment period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Pharmaceutical form:Capsule Route of administration: Oral
Sanofi Administrative Office
Gdansk, Poland
Comparison of the sleep quality
Difference in the average score of sleep quality
Time frame: From baseline to Day 21
Comparison of the average scores of sleep quality
Difference in the average score of sleep quality
Time frame: From baseline to Day 28
Comparison of time for getting asleep
Difference in the average score of time for getting asleep
Time frame: From baseline to Day 28
Comparison of sleep time
Difference in the average score of sleep time
Time frame: From baseline to Day 28
Comparison of number of nocturnal awakening
Difference in the average score of number of nocturnal awakening
Time frame: From baseline to Day 28
Comparison of number of nightmares
Difference in the average score of number of nightmares
Time frame: From baseline to Day 28
Comparison of awakening quality
Difference in the average score of awakening quality
Time frame: From baseline to Day 28
Comparison of mean tiredness
Difference in the average score of mean tiredness
Time frame: From baseline to Day 28
Adverse events (AEs)
Number of participants with AEs
Time frame: From baseline to Day 28
Dependency questionnaire
Assessment of product's effects dependency at Day 28
Time frame: At Day 28
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