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

NCT ID: NCT05456152

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 358 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2025-02-28

Brief Summary

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

Conditions

Chronic Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sublingual zolpidem

1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.

Group Type: EXPERIMENTAL

Sublingual Tablet

Intervention Type: DRUG

Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.

Interventions

Sublingual Tablet

Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site

São Paulo, São Paulo, Brazil

Countries

Brazil

Central Contacts

Alexandra F.D. Alves, MSc

Role: CONTACT

pesquisa.clinica@ncfarma.com.br

+551938878917

Other Identifiers

EMS0222- SERENA

Identifier Type: -

Identifier Source: org_study_id