A Non-inferiority Study With Two Treatment Arms Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

Study Overview
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Brief Summary
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The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia.

Detailed Description
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The primary objective of the study is to determine whether eszopiclone (Eurofarma) is non-inferior to the reference drug zopiclone (Imovane®, Sanofi-Aventis) in the treatment of insomnia. To that end, the latency to persistent sleep (LPS) will be used as a primary endpoint at the end of the treatment, measured by polysomnography. The secondary objectives and endpoints of this study are as follows: To evaluate the efficiency of eszopiclone compared to zopiclone by means of the patient's clinical history, using as secondary endpoints: Variables of the sleep diary of the Associação Fundo de Incentivo à Psicofarmacologia (see Appendix A), namely: Latency time to the beginning of the sleep; Frequency of night wake-ups; Time awake during bedtime; Early morning awakening; Total time in bed; Sleep efficiency; Sleep variables measured by actigraph; Insomnia Severity Index (see Appendix B);45 Pittsburgh Sleep Quality Index (see Appendix C);46 To evaluate the safety of eszopiclone compared to zopiclone by means of adverse events in each study arm.

Official Title
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A Phase III, Non-inferiority, Double-blind, Unicenter Clinical Trial With Two Treatment Arms - Test Group With Eszopiclone 3 mg Versus Zopiclone 7.5 mg - for the Treatment of Insomnia

Conditions
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INSOMNIA

Intervention / Treatment
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* Drug: Eszopiclone
* Drug: Zopiclone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent form for the study; Be ≥ 20 to ≥ 64 years old; Have diagnosis of symptomatic primary insomnia for at least 3 months; Have polysomnography conducted at least 90 days before the inclusion in the study with sleep time less than 6.5 hours and sleep latency ≥ 20 minutes; Be able not to take any insomnia medication for 14 days before randomization to the study (washout period). Exclusion Criteria: Diagnosis of other sleep disorder by polysomnography conducted 90 days before the inclusion in the study; Use of any medication affecting the sleep, such as psychotropic, hypnotic or antihistamine agents for at least 15 days before the inclusion in the study; Use of any herbal supplement for insomnia or melatonin during the 14 days before entering the study; Current use of liver metabolized medication, especially those metabolized through the cytochrome P450 enzyme complex, especially through the CYP3A4 and/or CYP2E1 routes; History of daily use of alcohol beverages in quantities equivalent - from the ethanol standpoint - to two cans of beer a day (35 g of alcohol/day); History of substance abuse or dependence; Patients with severe co-morbidities (at the investigator's opinion); Presence of liver disorders, cirrhosis or liver failure; Presence of psychiatric disorders diagnosed at the adult life or currently under treatment; Pregnant and breastfeeding women and women who want to become pregnant during the study period and who refuse to use a proper contraceptive methods during the study.

Ages Eligible for Study
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Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eszopiclone 3 mg<br>Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) | Drug: Eszopiclone<br>* Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)<br>|
| Active Comparator: zopiclone 7,5mg<br>Zopiclone once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment) | Drug: Zopiclone<br>* Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to persistent sleep measured by polysomnography | Determine whether eszopiclone is noninferior to the reference drug zopiclone (Imovane®) in the treatment of insomnia. The latency to persistent sleep will be used as a primary endpoint at the end of the treatment, measured by polysomnography | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficiency using the variables latency time to persistent sleep, frequency of night awakenings, time awake during bedtime, early morning awakening, total time in bed, total time awake and sleep efficiency |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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INSOMNIA, FOR THE TREATMENT OF INSOMNIA