Status:
COMPLETED
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
Lead Sponsor:
EMS
Collaborating Sponsors:
Associação Fundo de Incentivo à Pesquisa
Conditions:
Primary Insomnia
Eligibility:
All Genders
20-64 years
Phase:
PHASE4
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 wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2013
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01896336
Start Date
February 18 2013
End Date
December 10 2013
Last Update
February 24 2021
Active Locations (1)
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1
AFIP
São Paulo, Sâo Paulo, Brazil, 04020-060