NCT01896336

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2013

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2013

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

July 8, 2013

Last Update Submit

February 23, 2021

Conditions

Primary Insomnia

Outcome Measures

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.

    90 days

Secondary Outcomes (1)

  • Safety will be evaluated by the adverse events occurrences

    90 days

Study Arms (2)

5mg sublingual Zolpidem hemitartrate

EXPERIMENTAL

1 QD

Drug: Zolpidem Hemitartrate

10 mg oral Zolpidem hemitartrate

ACTIVE COMPARATOR

1 QD.

Drug: Zolpidem Hemitartrate

Interventions

Zolpidem HemitartrateDRUG

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
10 mg oral Zolpidem hemitartrate5mg sublingual Zolpidem hemitartrate

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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;
  • Signature of IC.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AFIP

São Paulo, Sâo Paulo, 04020-060, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 31859791DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Zolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Dalva R Poyares, MD

    Associacao Fundo de Incentivo a Psicofarmcologia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 11, 2013

Study Start

February 18, 2013

Primary Completion

November 11, 2013

Study Completion

December 10, 2013

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

BR(1)