Efficacy and Safety of Two Doses of Hipnos in the Treatment of Adults With Insomnia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of three doses of Hipnos medication in adults with insomnia.

Official Title
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Randomized, Double-blind, Double-dummy, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Two Doses of Hipnos Medication in the Treatment of Adults With Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Drug: Hipnos 3
* Drug: Hipnos 5
* Other: Hipnos 5 Placebo
* Other: Hipnos 3 Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants aged 50 years or more; Diagnosis of insomnia disorder according to criteria defined by the DSM-V; Sleep latency ≥ 20 minutes obtained through polysomnography performed prior to the randomization visit. Exclusion Criteria: Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; Known hypersensitivity to the formula components used during the clinical trial; Decompensated diabetes mellitus, hypothyroidism or hyperthyroidism; History of hepatic impairment; Current smoking; Pregnancy or risk of pregnancy and lactating patients; History of sleep-disordered breathing, sleep disorders associated with changes in circadian rhythm and severe neurological and psychiatric disorders; Diagnosis of clinical diseases that interfere with sleep; Participants who have used psychostimulant medications, antidepressants and/ or antipsychotic with sedative effects and/or antiepileptic; Participation in clinical trial in the year prior to this study.

Ages Eligible for Study
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Minimum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIPNOS 3<br>The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 3 and 1 placebo tablet, oral, once a day. | Drug: Hipnos 3<br>* 1 tablet, oral, once a day.<br>* Other names: EMS tablet;Other: Hipnos 5 Placebo<br>* 1 tablet, oral, once a day.<br>* Other names: Placebo;|
| Experimental: HIPNOS 5<br>The study is double-dummy. Thus, the patient will take 2 tablets, as follow: 1 tablet Hipnos 5 and 1 placebo tablet, oral, once a day. | Drug: Hipnos 5<br>* 1 tablet, oral, once a day.<br>* Other names: EMS tablet;Other: Hipnos 3 Placebo<br>* 1 tablet, oral, once a day.<br>* Other names: Placebo;|
| Placebo Comparator: HIPNOS Placebo<br>The study is double-dummy. Thus, the patient will take 2 tablet of placebo, oral, once a day. | Other: Hipnos 5 Placebo<br>* 1 tablet, oral, once a day.<br>* Other names: Placebo;Other: Hipnos 3 Placebo<br>* 1 tablet, oral, once a day.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep latency time, obtained through polysomnography, performed before and at the end of treatment. |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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insomnia