Overview

This trial is active, not recruiting.

Condition primary insomnia
Treatment zolpidem hemitartrate
Phase phase 4
Sponsor EMS
Collaborator Associação Fundo de Incentivo à Pesquisa
Start date February 2013
End date August 2013
Trial size 60 participants
Trial identifier NCT01896336, ZPDEMS1011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
1 QD
zolpidem hemitartrate Patz - 5mg sublingual zolpidem hemitartrate
Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD
(Active Comparator)
1 QD.
zolpidem hemitartrate Patz - 5mg sublingual zolpidem hemitartrate
Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD

Primary Outcomes

Measure
Efficacy will be measured by sleep induction and maintenance.
time frame: 90 days

Secondary Outcomes

Measure
Safety will be evaluated by the adverse events occurrences
time frame: 90 days

Eligibility Criteria

Male or female participants from 20 years up to 64 years old.

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.

Additional Information

Official title 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
Principal investigator Dalva R Poyares, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by EMS.