Chronic Insomnia
Conditions
Keywords
Chronic insomnia, Sleep disorder
Brief summary
The purpose of this study is to evaluate the safety and efficacy of sublingual zolpidem during the long-term treatment of insomnia.
Interventions
Sublingual zolpidem - 1 sublingual tablet 30 minutes before bed time.
Sponsors
EMS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the safety profile of sublingual zolpidem during the long-term insomnia treatment. | 60 days. | The safety profile will be assessed considering the number and percentage of each adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the adverse events during 7 days after the last dose administration. | 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 evaluate daytime sleepiness in the next morning. | 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 number of adverse events in different periods of the clinical trial. | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of sublingual zolpidem in the improvement of time awake before onset. | 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. |
| To assess the efficacy of sublingual zolpidem in the improvement of sleep quality. | 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 sleep induction. | 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. |
Countries
Brazil
Contacts
Primary ContactAlexandra F.D. Alves, MSc
Outcome results
None listed