NCT05456152

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
358

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2024

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

7 months

First QC Date

July 8, 2022

Last Update Submit

September 5, 2023

Conditions

Chronic Insomnia

Keywords

Chronic insomniaSleep disorder

Outcome Measures

Primary Outcomes (1)

  • To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.

    The safety profile will be assessed considering the number and percentage of each adverse event.

    60 days.

Secondary Outcomes (4)

  • To evaluate daytime sleepiness in the next morning.

    60 days.

  • To assess the adverse events during 7 days after the last dose administration.

    7 days.

  • To assess the number of adverse events in different periods of the clinical trial.

    60 days.

  • To assess the number of participants with adverse events in different periods of the clinical trial.

    60 days.

Other Outcomes (3)

  • To assess the efficacy of sublingual zolpidem in the sleep induction.

    60 days.

  • To assess the efficacy of sublingual zolpidem in the improvement of sleep quality.

    60 days.

  • To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset.

    60 days.

Study Arms (1)

Sublingual zolpidem

EXPERIMENTAL

1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.

Drug: Sublingual Tablet

Interventions

Sublingual TabletDRUG

Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.

Sublingual zolpidem

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
  • Age between 18 to 64 years;
  • Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
  • Participants with difficulty in initiating or maintaining sleep parameters.

You may not qualify if:

  • Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
  • Known hypersensitivity to any of the formula compounds;
  • Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
  • Participants using sedatives or hypnotic medications;
  • Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
  • Participants with history of drug and alcohol abuse in the past 2 years;
  • Participants with current smoking habits during the night period;
  • Participants who treated insomnia in the last 3 months;
  • Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
  • Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
  • Participants with current or medical history of cancer in the last 5 years;
  • Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational Site

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake Disorders

Interventions

Administration, Sublingual

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, OralDrug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Alexandra F.D. Alves, MSc

CONTACT

+551938878917pesquisa.clinica@ncfarma.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

July 13, 2022

Study Start

June 1, 2024

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)