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CompletedNCT01896336Updated Feb 24, 2021

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

A Phase 4 interventional study of Zolpidem Hemitartrate in Primary Insomnia, sponsored by EMS. Completed at 1 site in Brazil. Open to participants aged 20 Years to 64 Years. Per ClinicalTrials.gov, last updated 2021-02-24.

Sponsored by EMS · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Feb 2013, registered Jul 2013).
Phase
Phase 4
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
20 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Primary Insomnia
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 67 is close to the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    5mg sublingual Zolpidem hemitartrate

    1 QD

    Drug: Zolpidem Hemitartrate

  • Active comparator
    10 mg oral Zolpidem hemitartrate

    1 QD.

    Drug: Zolpidem Hemitartrate

Interventions

  • DrugZolpidem Hemitartrate

    Patz - 5mg sublingual zolpidem hemitartrate 1 QD Stilnox - 10mg oral zolpidem hemitartrate 1 QD

    Also known as: Patz - 5mg sublingual zolpidem hemitartrate, Stilnox - 10mg oral zolpidem hemitartrate

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 90 days

Secondary outcomes

  1. Safety will be evaluated by the adverse events occurrences

    Adverse events will be collected and followed in order to evaluate safety and tolerability

    Time frame: 90 days

07

Study locations

1 site
  • AFIP
    São Paulo, Sâo Paulo 04020-060, Brazil
08

References and documents

Publications

  • 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. PubMed 31859791 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01896336
Lead sponsor
EMS
Collaborators
Associação Fundo de Incentivo à Pesquisa
Responsible party
Sponsor
First posted
Jul 11, 2013
Start date
Feb 18, 2013
Primary completion
Nov 11, 2013
Completion
Dec 10, 2013
Last update
Feb 24, 2021

Study contacts

Dalva R Poyares, MD
principal investigator · Associacao Fundo de Incentivo a Psicofarmcologia

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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