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

• ClinicalTrials.gov Identifier: NCT05456152
• Recruitment Status: Not yet recruiting
• First Posted: July 13, 2022
• Last Update Posted: August 9, 2022
• Sponsor: EMS
• Information provided by (Responsible Party): EMS

Tracking Information

• First Submitted Date: July 8, 2022
• First Posted Date: July 13, 2022
• Last Update Posted Date: August 9, 2022
• Estimated Study Start Date: June 2023
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 8, 2022)

To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment. [ Time Frame: 60 days. ]

The safety profile will be assessed considering the number and percentage of each adverse event.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 5, 2022)

• To evaluate daytime sleepiness in the next morning. [ Time Frame: 60 days. ]
  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.
• To assess the adverse events during 7 days after the last dose administration. [ Time Frame: 7 days. ]
  The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.
• To assess the number of adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
  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.
• To assess the number of participants with adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
  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.

Original Secondary Outcome Measures (submitted: July 8, 2022)

• To evaluate daytime sleepiness in the next morning. [ Time Frame: 60 days. ]
  The daytime sleepiness will be assessed using the Epworth Sleepiness Scale.
• To assess the adverse events during 7 days after the last dose administration. [ Time Frame: 7 days. ]
  The safety profile will be assessed considering the number and percentage of each adverse event occurred 7 days after the last dose administration.
• To assess the number of adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
  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.
• To assess the number of participants with adverse events in different periods of the clinical trial. [ Time Frame: 60 days. ]
  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.

Current Other Pre-specified Outcome Measures (submitted: July 8, 2022)

• To assess the efficacy of sublingual zolpidem in the sleep induction. [ Time Frame: 60 days. ]
  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.
• To assess the efficacy of sublingual zolpidem in the improvement of sleep quality. [ Time Frame: 60 days. ]
  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.
• To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset. [ Time Frame: 60 days. ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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.
• Brief Summary: The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Insomnia

Intervention

Drug: Sublingual Tablet

Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.

Study Arms

Experimental: Sublingual zolpidem

1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.

Intervention: Drug: Sublingual Tablet

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: July 8, 2022): 358
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 2025
• Estimated Primary Completion Date: January 2025 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Alexandra F.D. Alves, MSc; +551938878917; pesquisa.clinica@ncfarma.com.br

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT05456152
• Other Study ID Numbers: EMS0222- SERENA
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: EMS
• Original Responsible Party: Same as current
• Current Study Sponsor: EMS
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: EMS
• Verification Date: August 2022