Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
- Registration Number
- NCT01896336
- Lead Sponsor
- EMS
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 5mg sublingual Zolpidem hemitartrate Zolpidem Hemitartrate 1 QD 10 mg oral Zolpidem hemitartrate Zolpidem Hemitartrate 1 QD.
- Primary Outcome Measures
Name Time Method Efficacy will be measured by sleep induction and maintenance. 90 days 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.
- Secondary Outcome Measures
Name Time Method Safety will be evaluated by the adverse events occurrences 90 days Adverse events will be collected and followed in order to evaluate safety and tolerability
Trial Locations
- Locations (1)
AFIP
🇧🇷São Paulo, Sâo Paulo, Brazil