Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
Key facts
- Where
- Bragança Paulista, BrazilSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07420816, who can take part
Where in Brazil
- UNIFAG - Casa Nossa Senhora da PAZ -ASFBragança Paulista, BrazilContact: Rafaella Santos Dantas BeltrameTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Apsen Farmaceutica S.A.
- Trial code
- NCT07420816
- Record updated
- 21 August 2026
- Original description
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.Read full original descriptionShow less
Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder
The purpose of this study is to evaluate the efficacy of APSTZD compared to one active drug and placebo in insomnia treatment.
Inclusion: 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: 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; Participants diagnosed with severe liver failure; 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.