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.

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.