Chronic InsomniaPhase 3NCT05456152
Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
A Phase 3 study testing Sublingual Tablet in people with Chronic Insomnia, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Sublingual Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2024to Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
- Conditions
- Chronic Insomnia
- Being tested
- Sublingual Tablet
- Keywords
- Chronic insomnia, Sleep disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual TabletDrug
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.
| Study group | Role | What they receive |
|---|---|---|
| Sublingual zolpidem | Experimental | 1 sublingual tablet (5mg) 30 minutes before bed time during 60 days. Receives: Drug: Sublingual Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 days.
Secondary outcomes (4)
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.
Measured: 60 days.
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.
Measured: 7 days.
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.
Measured: 60 days.
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.
Measured: 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJun 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456152
- Sponsor's protocol ID
- EMS0222- SERENA
- Status last verified
- Sep 2023
- First submitted
- 8 Jul 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05456152
- Acronym / sponsor ID
- EMS0222- SERENA
- Conditions
- Chronic Insomnia
- Keywords
- Chronic insomnia, Sleep disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sublingual zolpidem | Experimental | Drug: Sublingual Tablet1 sublingual tablet (5mg) 30 minutes before bed time during 60 days. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sublingual TabletSublingual zolpidem - 1 sublingual tablet 30 minutes before bed time. | Drug | Sublingual zolpidem |
Primary outcome
To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.
Time frame: 60 days.
The safety profile will be assessed considering the number and percentage of each adverse event.
4 secondary outcomes
To evaluate daytime sleepiness in the next morning.
Time frame: 60 days.
To assess the adverse events during 7 days after the last dose administration.
Time frame: 7 days.
To assess the number of adverse events in different periods of the clinical trial.
Time frame: 60 days.
To assess the number of participants with adverse events in different periods of the clinical trial.
Time frame: 60 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sublingual Tablet in people with Chronic Insomnia, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra F.D. Alves, MSc (+551938878917, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment. (time frame: 60 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.