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Biolab Zolpidem Orodispersible 1.0 mg, 1.75 mg and 3.5 mg to Treat Maintenance Insomnia Disorder. — ZOLP_18_01  

Insomnia Disorder Clinical Trial

Official title:
Phase II / III Study, One Center, Double-Blind, With Placebo Use, in Parallel Groups to Assess the Efficacy and Safety of Zolpidem® Orodispersible in Adult Subjects (Females and Males) in the Treatment of Maintenance Insomnia Disorder.

Clinical Trial Summary

Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography.

Clinical Trial Description

Information provided evidence for the therapeutic use of Zolpidem® in the treatment of insomnia. Several studies have emphasized the importance of using Zolpidem® in small doses, in the orodispersible form, in the treatment of insomnia. Accordingly, Biolab Sanus is developing a product in the form of orodispersible tablet containing 1.0 mg, 1.75 mg and 3.5 mg of Zolpidem®. Thus, it is intended to evaluate the efficacy of Zolpidem® Orodispersible 1.0 mg or 1.75 mg in women and Zolpidem Orodispersible 1.75 mg or 3.5 mg in men for the improvement of the maintenance insomnia disorder, through the evaluation of the Insomnia Severity Index, and using a Sleep Diary throughout the study, as well as to evaluate the latency of the sleep after a spontaneous or provoked wake up measured by polysomnography. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03885141
Study type Interventional
Source Biolab Sanus Farmaceutica
Contact Luciano R Pinto Junior, PhD
Phone 55.11.973342037
Email lucianoribeiro48@gmail.com
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date March 2021
Completion date December 2021
View Details
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