APSTZD for Insomnia: Safety and Effectiveness in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares APSTZD at multiple doses (APSTZD 1–4) with an active comparator and placebo in adults with insomnia disorder and sleep maintenance problems. Participants must be 18–64 years old, meet DSM-5 criteria for insomnia, and refrain from alcohol during treatment. The study evaluates both safety and efficacy over a six-week treatment period. Enrollment is at a single site in Bragança Paulista, São Paulo, led by Apsen Farmaceutica S.A. in collaboration with UNIFAG. Exclusion criteria include hypersensitivity to study drugs, recent substance use disorders, pregnancy, and severe liver failure.

Why it matters

Who can join: the full rules

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;

Where it's running

• UNIFAG - Casa Nossa Senhora da PAZ -ASF
  Bragança Paulista, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Bianca Zanetti
• Email: bianca.zanetti@apsen.com.br
• Phone: +55115641-2305

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.