NCT01896336

Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: EMS · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

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

* 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.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DRUG	Zolpidem Hemitartrate	Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD

Timeline

• Start date: 2013-02-18
• Primary completion: 2013-11-11
• Completion: 2013-12-10
• First posted: 2013-07-11
• Last updated: 2021-02-24

Locations

1 site across 1 country: Brazil