Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Phase II Randomized, Multicenter, Double-blind, Doubledummy, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07420816

Acronym

TINA

Enrollment

222

Registered

2026-02-19

Start date

2026-08-05

Completion date

2027-12-01

Last updated

2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Insomnia Chronic

Brief summary

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

Interventions

DRUGAPSTZD 1

APSTZD + placebo test 2 + placebo test 3 + placebo test 4 + comparator placebo 1

DRUGAPSTZD 2

APSTZD + placebo test 1 + placebo test 3 + placebo test 4 + comparator placebo 1

DRUGAPSTZD 3

APSTZD + placebo test 1 + placebo test 2 + placebo test 4 + comparator placebo 1

DRUGAPSTZD 4

APSTZD + placebo test 1 + placebo test 2 + placebo test 3 + comparator placebo 1

DRUGStilnox CR®

Stilnox CR® + placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4

DRUGPlacebo

placebo test 1 + placebo test 2 + placebo test 3 + placebo test 4 + comparator 1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography	Change from baseline after 2 weeks of treatment

Secondary

Measure	Time frame
Adverse events incidence and classification	Through study completion, up to 6 weeks

Countries

Brazil

Contacts

CONTACTBianca Zanetti

bianca.zanetti@apsen.com.br+55115641-2305

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026