Clinical trial NCT05456152: Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia
Official title: National, Multicenter, Open, Single-arm, Phase III Clinical Trial to Evaluate the Safety and Efficacy of Zolpidem in the Long-Term Treatment of Insomnia.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Insomnia
Keywords: Chronic insomnia
Sleep disorder
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 358
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.
timeFrame: 60 days.
Secondary outcomes:
measure: To evaluate daytime sleepiness in the next morning.
timeFrame: 60 days.
measure: To assess the adverse events during 7 days after the last dose administration.
timeFrame: 7 days.
measure: To assess the number of adverse events in different periods of the clinical trial.
timeFrame: 60 days.
measure: To assess the number of participants with adverse events in different periods of the clinical trial.
timeFrame: 60 days.
Other outcomes:
measure: To assess the efficacy of sublingual zolpidem in the sleep induction.
timeFrame: 60 days.
measure: To assess the efficacy of sublingual zolpidem in the improvement of sleep quality.
timeFrame: 60 days.
measure: To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset.
timeFrame: 60 days.
Locations:
city: São Paulo
country: Brazil
facility: Investigational Site
state: SP
Study officials:
References: