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

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

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.

Study Overview

• Status: Completed
• Conditions: Primary Insomnia
• Intervention / Treatment: Drug: Zolpidem Hemitartrate

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.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sâo Paulo
    • São Paulo, Sâo Paulo, Brazil, 04020-060
      • AFIP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be evaluated by the adverse events occurrences	Adverse events will be collected and followed in order to evaluate safety and tolerability	90 days

Collaborators and Investigators

• Sponsor: EMS
• Collaborators: Associação Fundo de Incentivo à Pesquisa
• Investigators: Principal Investigator: Dalva R Poyares, MD, Associacao Fundo de Incentivo a Psicofarmcologia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 18, 2013
• Primary Completion (ACTUAL): November 11, 2013
• Study Completion (ACTUAL): December 10, 2013

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 8, 2013
• First Posted (ESTIMATE): July 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Hypnotics and Sedatives; GABA Agents; Sleep Aids, Pharmaceutical; GABA-A Receptor Agonists; GABA Agonists; Zolpidem
• Other Study ID Numbers: ZPDEMS1011