Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia

Primary Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896336
• Other study ID #: ZPDEMS1011
• Status: Completed
• Phase: Phase 4
• Start date: February 18, 2013
• Est. completion date: December 10, 2013

Study information

• Verified date: February 2021
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 10, 2013
• Est. primary completion date: November 11, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Zolpidem Hemitartrate
Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD

Locations

Country	Name	City	State
Brazil	AFIP	São Paulo	Sâo Paulo

Sponsors (2)

Lead Sponsor	Collaborator
EMS	Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	90 days
Secondary	Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	90 days