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

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

Official Title
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National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Drug: Sublingual Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual zolpidem<br>1 sublingual tablet (5mg) 30 minutes before bed time during 60 days. | Drug: Sublingual Tablet<br>* Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 60 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic insomnia, Sleep disorder