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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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ClinicalTrials.gov Identifier: NCT01896336
Recruitment Status : Unknown
Verified September 2013 by EMS.
Recruitment status was:  Active, not recruiting
First Posted : July 11, 2013
Last Update Posted : September 25, 2013
Sponsor:
Collaborator:
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: Zolpidem Hemitartrate Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2013
Actual Primary Completion Date : August 2013
Estimated Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5mg sublingual Zolpidem hemitartrate
1 QD
Drug: Zolpidem Hemitartrate

Patz - 5mg sublingual zolpidem hemitartrate

1 QD

Stilnox - 10mg oral zolpidem hemitartrate

1 QD

Other Names:
  • Patz - 5mg sublingual zolpidem hemitartrate
  • Stilnox - 10mg oral zolpidem hemitartrate

Active Comparator: 10 mg oral Zolpidem hemitartrate
1 QD.
Drug: Zolpidem Hemitartrate

Patz - 5mg sublingual zolpidem hemitartrate

1 QD

Stilnox - 10mg oral zolpidem hemitartrate

1 QD

Other Names:
  • Patz - 5mg sublingual zolpidem hemitartrate
  • Stilnox - 10mg oral zolpidem hemitartrate




Primary Outcome Measures :
  1. Efficacy will be measured by sleep induction and maintenance. [ Time Frame: 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 :
  1. Safety will be evaluated by the adverse events occurrences [ Time Frame: 90 days ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability



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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896336


Locations
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Brazil
AFIP
São Paulo, Sâo Paulo, Brazil, 04020-060
Sponsors and Collaborators
EMS
Associação Fundo de Incentivo à Pesquisa
Investigators
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Principal Investigator: Dalva R Poyares, MD Associacao Fundo de Incentivo a Psicofarmcologia

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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01896336     History of Changes
Other Study ID Numbers: ZPDEMS1011
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: September 25, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Sleep Wake Disorders
Zolpidem
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Sleep Aids, Pharmaceutical
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action