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Completed

NCT Number: NCT01896336

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

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.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AFIP

São Paulo, Sâo Paulo, 04020-060, Brazil

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zolpidem Hemitartrate

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

EMS

Industry

Collaborators

  • Associação Fundo de Incentivo à Pesquisa

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2013
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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