Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
This trial is active, not recruiting.
|Collaborator||Associação Fundo de Incentivo à Pesquisa|
|Start date||February 2013|
|End date||August 2013|
|Trial size||60 participants|
|Trial identifier||NCT01896336, ZPDEMS1011|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Efficacy will be measured by sleep induction and maintenance.
time frame: 90 days
Safety will be evaluated by the adverse events occurrences
time frame: 90 days
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.
|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.|
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