Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia

National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.

The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Insomnia
• Intervention / Treatment: Drug: Sublingual Tablet

• Study Type: Interventional
• Enrollment (Estimated): 358
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alexandra F.D. Alves, MSc; Phone Number: +551938878917; Email: pesquisa.clinica@ncfarma.com.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
• Age between 18 to 64 years;
• Participants diagnosed with chronic insomnia defined by difficulty in initiating or maintaining sleep in the last 3 months for at least 3 nights a week according to DSM-V criteria and confirmed by polysomnography;
• Participants with difficulty in initiating or maintaining sleep parameters.

Exclusion Criteria:

• Participants with clinical or laboratory diagnose of non-treated hypothyroidism or hyperthyroidism, kidney or liver failure;
• Known hypersensitivity to any of the formula compounds;
• Participants with other sleep disorders according to the International Classification Sleep Disorders (3rd edition), example: sleep-relate breathing disorders, circadian rhythm sleep-wake disorders, parasomnias (including history of sleep-walking after hypnotic use) and sleep related movement disorders;
• Participants using sedatives or hypnotic medications;
• Participants with current diagnosis of depression or anxiety according to the Diagnostic and Statistical Manual of Mental Disorders;
• Participants with history of drug and alcohol abuse in the past 2 years;
• Participants with current smoking habits during the night period;
• Participants who treated insomnia in the last 3 months;
• Participants who are pregnant, breastfeeding or planning to get pregnant or female participants with the potential to become pregnant who are not using a reliable method of contraception;
• Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
• Participants with current or medical history of cancer in the last 5 years;
• Participants who participated in other research protocol in the last 12 months, unless the investigator judges that there may be a direct benefit to it.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sublingual zolpidem; 1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.	Drug: Sublingual Tablet; Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.	The safety profile will be assessed considering the number and percentage of each adverse event.	60 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate daytime sleepiness in the next morning.	The daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The scale has a score from 0 to 24 and a score more than 10 is considered as excessive daytime sleepiness.	60 days.
To assess the adverse events during 7 days after the last dose administration.	The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.	7 days.
To assess the number of adverse events in different periods of the clinical trial.	The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.	60 days.
To assess the number of participants with adverse events in different periods of the clinical trial.	The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.	60 days.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the efficacy of sublingual zolpidem in the sleep induction.	The efficacy will be evaluated considering any change in the Latency to Persistent Sleep parameter (LPS) after 60 days of treatment in comparison to the baseline measure.	60 days.
To assess the efficacy of sublingual zolpidem in the improvement of sleep quality.	The efficacy will be evaluated considering any change in the Sleep Efficiency parameter (SE) after 60 days of treatment in comparison to the baseline measure.	60 days.
To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset.	The efficacy will be evaluated considering any change in the Wake After Sleep Onset parameter (WASO) after 60 days of treatment in comparison to the baseline measure.	60 days.

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 8, 2022
• First Posted (Actual): July 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Chronic insomnia; Sleep disorder
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: EMS0222- SERENA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No