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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 Purpose

Primary Insomnia

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Zolpidem Hemitartrate
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Insomnia

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AFIP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5mg sublingual Zolpidem hemitartrate

10 mg oral Zolpidem hemitartrate

Arm Description

1 QD

1 QD.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability

Full Information

First Posted
July 8, 2013
Last Updated
February 23, 2021
Sponsor
EMS
Collaborators
Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01896336
Brief Title
Efficacy and Safety of 5 mg Sublingual Zolpidem vs 10mg Oral Zolpidem in the Induction and Maintenance of Sleep in Patients With Primary Insomnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 18, 2013 (Actual)
Primary Completion Date
November 11, 2013 (Actual)
Study Completion Date
December 10, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
Collaborators
Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5mg sublingual Zolpidem hemitartrate
Arm Type
Experimental
Arm Description
1 QD
Arm Title
10 mg oral Zolpidem hemitartrate
Arm Type
Active Comparator
Arm Description
1 QD.
Intervention Type
Drug
Intervention Name(s)
Zolpidem Hemitartrate
Other Intervention Name(s)
Patz - 5mg sublingual zolpidem hemitartrate, Stilnox - 10mg oral zolpidem hemitartrate
Intervention Description
Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD
Primary Outcome Measure Information:
Title
Efficacy will be measured by sleep induction and maintenance.
Description
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
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Description
Adverse events will be collected and followed in order to evaluate safety and tolerability
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalva R Poyares, MD
Organizational Affiliation
Associacao Fundo de Incentivo a Psicofarmcologia
Official's Role
Principal Investigator
Facility Information:
Facility Name
AFIP
City
São Paulo
State/Province
Sâo Paulo
ZIP/Postal Code
04020-060
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31859791
Citation
Castro LS, Otuyama LJ, Fumo-Dos-Santos C, Tufik S, Poyares D. Sublingual and oral zolpidem for insomnia disorder: a 3-month randomized trial. Braz J Psychiatry. 2020 Apr;42(2):175-184. doi: 10.1590/1516-4446-2019-0389. Epub 2019 Dec 20.
Results Reference
derived

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

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