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Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05456152
Recruitment Status : Not yet recruiting
First Posted : July 13, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
EMS

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

Condition or disease Intervention/treatment Phase
Chronic Insomnia Drug: Sublingual Tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 358 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Estimated Study Start Date : June 2023
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sublingual zolpidem
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
 Drug: Sublingual Tablet
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. To evaluate daytime sleepiness in the next morning. [ Time Frame: 60 days. ]
    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.

  2. To assess the adverse events during 7 days after the last dose administration. [ Time Frame: 7 days. ]
    The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.

  3. To assess the number of adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
    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.

  4. To assess the number of participants with adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
    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.


Other Outcome Measures:
  1. To assess the efficacy of sublingual zolpidem in the sleep induction. [ Time Frame: 60 days. ]
    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.

  2. To assess the efficacy of sublingual zolpidem in the improvement of sleep quality. [ Time Frame: 60 days. ]
    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.

  3. To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset. [ Time Frame: 60 days. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05456152


Contacts
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Contact: Alexandra F.D. Alves, MSc +551938878917 pesquisa.clinica@ncfarma.com.br

Locations
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Brazil
Investigational Site
São Paulo, SP, Brazil
Sponsors and Collaborators
EMS
More Information
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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT05456152    
Other Study ID Numbers: EMS0222- SERENA
First Posted: July 13, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by EMS:
Chronic insomnia
Sleep disorder
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders