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.
* 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD
AFIP
São Paulo, Sâo Paulo, Brazil
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.
Time frame: 90 days
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time frame: 90 days
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