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

Chronic Insomnia Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05456152
• Other study ID #: EMS0222- SERENA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: February 2025

Study information

• Verified date: September 2023
• Source: EMS
• Contact: Alexandra F.D. Alves, MSc
• Phone: +551938878917
• Email: pesquisa.clinica[@]ncfarma.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 358
• Est. completion date: February 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Sublingual Tablet
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.

Locations

Country	Name	City	State
Brazil	Investigational Site	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To assess the efficacy of sublingual zolpidem in the sleep induction.	The efficacy will be evaluated considering any change in the Latency to Persistent Sleep parameter (LPS) after 60 days of treatment in comparison to the baseline measure.	60 days.
Other	To assess the efficacy of sublingual zolpidem in the improvement of sleep quality.	The efficacy will be evaluated considering any change in the Sleep Efficiency parameter (SE) after 60 days of treatment in comparison to the baseline measure.	60 days.
Other	To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset.	The efficacy will be evaluated considering any change in the Wake After Sleep Onset parameter (WASO) after 60 days of treatment in comparison to the baseline measure.	60 days.
Primary	To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment.	The safety profile will be assessed considering the number and percentage of each adverse event.	60 days.
Secondary	To evaluate daytime sleepiness in the next morning.	The daytime sleepiness will be assessed using the Epworth Sleepiness Scale (ESS). The scale has a score from 0 to 24 and a score more than 10 is considered as excessive daytime sleepiness.	60 days.
Secondary	To assess the adverse events during 7 days after the last dose administration.	The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.	7 days.
Secondary	To assess the number of adverse events in different periods of the clinical trial.	The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.	60 days.
Secondary	To assess the number of participants with adverse events in different periods of the clinical trial.	The safety profile will be assessed considering the number of adverse events during the first 30 days and from 31 to 60 days of treatment.	60 days.