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

NCT01896336 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-02-24

No results posted yet for this study

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.

Conditions

  • Primary Insomnia

Interventions

DRUG

Zolpidem Hemitartrate

Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD

Sponsors & Collaborators

  • Associação Fundo de Incentivo à Pesquisa

    collaborator OTHER

  • EMS

    lead INDUSTRY

Principal Investigators

  • Dalva R Poyares, MD · Associacao Fundo de Incentivo a Psicofarmcologia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-18
Primary Completion
2013-11-11
Completion
2013-12-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01896336 on ClinicalTrials.gov