APSTZD 1: APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 2: APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1
APSTZD 3: APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1
APSTZD 4: APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1
Stilnox CR®: Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4
Placebo: placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1
Study summary
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
Eligibility
Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants aged between 18 and 64 years;
* Participants diagnosed with insomnia disorder according to the criteria defined by the DSM-V (1) and who report sleep maintenance disorder;
* Participants who agree not to use alcoholic beverages during the entire treatment period (6 weeks).
Exclusion Criteria:
* Participants with known hypersensitivity to the active ingredients used during the trial or who have exhibited complex sleep behavior after using them;
* Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
* Women who are pregnant or breastfeeding, as well as women who have a positive result on a pregnancy test (β-hCG) during the screening period of the trial;
* Participants diagnosed with severe liver failure;
Primary outcome measure(s)
Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography — Change from baseline after 2 weeks of treatment
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
