Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorApsen Farmaceutica S.A.
About this trial
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- APSTZD 1
- APSTZD 2
- APSTZD 3
- APSTZD 4
- Stilnox CR®
- Placebo
Treatment groups
222 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov