insomnia
Conditions
Interventions
Dimdazenil:Take the medication orally before bedtime
at least three times a week.
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, all of the following selection criteria must be met: 1) Age = 18 and = 65 years old, gender not limited; 2) Take zolpidem, zopiclone, and dexzopiclone at least 3 nights a week within 2 weeks prior to the start of conversion therapy Treatment with either Long or Zaleplon (limited to one), and dissatisfaction with treatment efficacy or safety (baseline) Insomnia patients with overall satisfaction<4 and hope to switch to other medication treatments; 3) Intending to receive treatment with Dexmedetomidine; 4) Can ensure at least 7 hours of sleep time conditions; 5) Ability to read and fill out sleep diaries; 6) Voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: Those who meet any of the following exclusion criteria are not eligible to participate in this study: 1) Contraindications for the use of Dedasinib include allergies to any excipients of Dedasinib and severe obstructive symptoms Sleep apnea (OSA), respiratory dysfunction, or myasthenia gravis; 2) Simultaneous use of two or more benzodiazepine receptor agonists within 2 weeks prior to the start of conversion therapy Therapy; 3) Used within 7 days prior to enrollment or within less than 5 drug half lives, except for two drugs other than benzodiazepines Two or more drugs or health supplements that regulate sleep function or affect sleep; 4) Non pharmacological interventions for insomnia, such as cognitive-behavioral therapy, should be initiated within 7 days prior to the start of conversion therapy Physical therapy, etc.); 5) Pregnant and lactating women; 6) Researchers believe that other situations are not suitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who are satisfied with the overall drug treatment after 14 days of treatment with Dimdazenil (Likert -7-point comprehensive satisfaction score = 5); | — |
Secondary
| Measure | Time frame |
|---|---|
| sTST;sSL;sSE;ISI;Changes in daytime function (Insomnia Severity Index Scale ISI: 5-7 items) scores compared to baseline after 14 days of treatment with Dimdazenil;Changes in Flinders Fatigue Scale scores between baseline and daytime fatigue levels after 14 days of treatment with Dimdazenil;Changes in daytime sleepiness (Epworth Sleepiness Scale) scores compared to baseline after 14 days of treatment with Dimdazenil;Incidence of adverse events during treatment with Dimdazenil; | — |
Countries
China
Contacts
Public ContactZhao Min
Shanghai Mental Health Center
Outcome results
None listed