Back to resultsSafety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
Primary Purpose
Chronic Insomnia
Status
Not yet recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Sublingual Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Insomnia focused on measuring Chronic insomnia, Sleep disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sublingual zolpidem
Arm Description
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To evaluate daytime sleepiness in the next morning.
The daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The scale has a score from 0 to 24 and a score more than 10 is considered as excessive daytime sleepiness.
To assess the adverse events during 7 days after the last dose administration.
The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.
To assess the number of adverse events in different periods of the clinical trial.
The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
To assess the number of participants with adverse events in different periods of the clinical trial.
The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05456152
Brief Title
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
Official Title
National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Insomnia
Keywords
Chronic insomnia, Sleep disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
358 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sublingual zolpidem
Arm Type
Experimental
Arm Description
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
Intervention Type
Drug
Intervention Name(s)
Sublingual Tablet
Intervention Description
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.
Primary Outcome Measure Information:
Title
To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.
Description
The safety profile will be assessed considering the number and percentage of each adverse event.
Time Frame
60 days.
Secondary Outcome Measure Information:
Title
To evaluate daytime sleepiness in the next morning.
Description
The daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The scale has a score from 0 to 24 and a score more than 10 is considered as excessive daytime sleepiness.
Time Frame
60 days.
Title
To assess the adverse events during 7 days after the last dose administration.
Description
The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.
Time Frame
7 days.
Title
To assess the number of adverse events in different periods of the clinical trial.
Description
The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
Time Frame
60 days.
Title
To assess the number of participants with adverse events in different periods of the clinical trial.
Description
The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.
Time Frame
60 days.
Other Pre-specified Outcome Measures:
Title
To assess the efficacy of sublingual zolpidem in the sleep induction.
Description
The efficacy will be evaluated considering any change in the Latency to Persistent Sleep parameter (LPS) after 60 days of treatment in comparison to the baseline measure.
Time Frame
60 days.
Title
To assess the efficacy of sublingual zolpidem in the improvement of sleep quality.
Description
The efficacy will be evaluated considering any change in the Sleep Efficiency parameter (SE) after 60 days of treatment in comparison to the baseline measure.
Time Frame
60 days.
Title
To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset.
Description
The efficacy will be evaluated considering any change in the Wake After Sleep Onset parameter (WASO) after 60 days of treatment in comparison to the baseline measure.
Time Frame
60 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra F.D. Alves, MSc
Phone
+551938878917
Email
pesquisa.clinica@ncfarma.com.br
Facility Information:
Facility Name
Investigational Site
City
São Paulo
State/Province
SP
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
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