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

• Status: Not yet recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS

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.