A Phase 3 interventional study of Sublingual Tablet in Chronic Insomnia, sponsored by EMS. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by EMS · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
1,855 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's planned enrollment of 358 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 sublingual tablet (5mg) 30 minutes before bed time during 60 days.
Drug: Sublingual Tablet
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.
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.
Time frame: 60 days.
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.
Time frame: 60 days.
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.
Time frame: 7 days.
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.
Time frame: 60 days.
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.
Time frame: 60 days.
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.
Time frame: 60 days.
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.
Time frame: 60 days.
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.
Time frame: 60 days.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
EMS