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

EMS0222- SERENA

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

2024-06-01

2025-01-01

2025-02-01

Not yet recruiting

Early phase I

358

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 358, 'type': 'ESTIMATED'}}

2023-09-07