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Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

NCT07420816

RecruitingPhase 2

Sponsor: Apsen Farmaceutica S.A.

Conditions: Insomnia, Insomnia Chronic

Interventions: APSTZD 1, APSTZD 2, APSTZD 3, APSTZD 4, Stilnox CR®

Countries: Brazil

The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.

Eligibility overview

Sex: ALL

Age: 18 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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;

Locations (1)

Bragança Paulista, São Paulo, Brazil