Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary 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 sublingual zolpidem presentation 5 mg in the induction of sleep in patients with primary insomnia.

Detailed Description
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National study, phase IV, single-center, double-blind, randomized, parallel, controlled by zolpidem 10mg oral. Experiment duration: 93 days. 05 visits (days -3, 0, 15, 45 and 90). Efficacy will be evaluated for: Sleep induction and the maintenance of sleep. Adverse events evaluation.

Official Title
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National Study, Phase IV, Single-center, Double-blind, Randomized, Parallel, Controlled by 10 mg Oral Zolpidem, in Evaluating the Efficacy and Safety of Zolpidem 5 mg Sublingual in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

Conditions
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Primary Insomnia

Intervention / Treatment
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* Drug: Zolpidem Hemitartrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged between 20 and 64 years; Diagnosis of primary insomnia according to criteria defined by DSM-IV; Difficulty in maintaining sleep and waking up until 3 am; Not having used any psychoactive drug in the last 30 days prior to their inclusion in the study; Signature of IC. Exclusion Criteria: Previous history of serious medical illness, neurological or psychiatric disorder; Allergy or hypersensitivity to zolpidem; Obstructive Sleep Apnea syndrome; Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h; Other secondary sleep disorders; History of substance abuse or dependence; History of daily consumption of alcoholic beverages; Pregnancy, lactation or refusal to use safe 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5mg sublingual Zolpidem hemitartrate<br>1 QD | Drug: Zolpidem Hemitartrate<br>* Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD<br>* Other names: Stilnox - 10mg oral zolpidem hemitartrate;|
| Active Comparator: 10 mg oral Zolpidem hemitartrate<br>1 QD. | Drug: Zolpidem Hemitartrate<br>* Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD<br>* Other names: Stilnox - 10mg oral zolpidem hemitartrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy will be measured by sleep induction and maintenance. | Sleep induction is measured by time to sleep after administration of the investigational product. The maintenance will be measured by the use of medication in the middle of the night and also by the elapsed time to sleep after administration of the investigational drug. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated by the adverse events occurrences | Adverse events will be collected and followed in order to evaluate safety and tolerability | 90 days |