Efficacy and Safety of APSTZD in the Treatment of Insomnia Disorder

NCT07420816 | Not Yet Recruiting Phase 2

• 1 other identifier: APS002/2024
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia; Insomnia Chronic

Outcome Measures

Primary Outcomes (1)

• Reduction in WASO 6h (Wake After Sleep Onset) assessed by polysomnography

  Change from baseline after 2 weeks of treatment

Secondary Outcomes (1)

• Adverse events incidence and classification

  Through study completion, up to 6 weeks

Study Arms (6)

APSTZD 1

EXPERIMENTAL

5 oral tablets, once a day, before bedtime, for 6 weeks.

Drug: APSTZD 1

APSTZD 2

EXPERIMENTAL

5 oral tablets, once a day, before bedtime, for 6 weeks.

Drug: APSTZD 2

APSTZD 3

EXPERIMENTAL

5 oral tablets, once a day, before bedtime, for 6 weeks.

Drug: APSTZD 3

APSTZD 4

EXPERIMENTAL

5 oral tablets, once a day, before bedtime, for 6 weeks.

Drug: APSTZD 4

Stilnox CR®

ACTIVE COMPARATOR

5 oral tablets, once a day, before bedtime, for 6 weeks.

Drug: Stilnox CR®

Placebo

PLACEBO COMPARATOR

5 oral tablets, once a day, before bedtime, for 6 weeks.

Drug: Placebo

Interventions

APSTZD 2 DRUG

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

APSTZD 2

APSTZD 3 DRUG

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

APSTZD 3

APSTZD 4 DRUG

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

APSTZD 4

Stilnox CR® DRUG

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

Stilnox CR®

Placebo DRUG

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

Placebo

APSTZD 1 DRUG

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

APSTZD 1

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (1)

UNIFAG - Casa Nossa Senhora da PAZ -ASF

Bragança Paulista, São Paulo, 12916-900, Brazil

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Fernanda Martinez Scalzaretto

CONTACT

+551156448200; fernanda.martinez@apsen.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 19, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): September 23, 2027
• Study Completion (Estimated): September 23, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)