Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Insomnia, Insomnia Chronic

In brief

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

Key facts

Study ID

NCT07420816

Run by

Apsen Farmaceutica S.A.

People needed

222

Starts

2026-03-26

Expected to finish

2027-09-23

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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