Chronic insomnia
Conditions
Interventions
Intervention group:Sleep hygiene education + Discontinuation of the currently used benzodiazepines. During the conversion treatment period, switch to dedacinib capsules, administered orally before bed
Control group:Sleep hygiene education + Discontinue the currently used benzodiazepines. During the conversion treatment period, switch to zolpidem tartrate tablets, administered orally before bedtime,
Sponsors
The First Hospital of Hebei Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years old (inclusive), regardless of gender; 2.Meet the diagnostic criteria for chronic insomnia disorder in the International Classification of Sleep Disorders - 3 (ICSD - 3); 3.Have been using benzodiazepines continuously before bedtime for more than 3 months to address insomnia problems, with a frequency of taking the drug >= 3 days per week. 4.Voluntarily provide a written informed consent form;
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to any excipients of the study drugs dedacinib or zolpidem; 2. Suffering from severe obstructive sleep apnea (OSA), respiratory insufficiency, myasthenia gravis, etc. 3. Previous history of epilepsy, schizophrenia, bipolar disorder, developmental delay, or cognitive impairment; 4. Simultaneous use of two or more benzodiazepine receptor agonists for treatment; 5. Within 7 days before enrollment or within less than 5 drug half-lives, drugs that may change the alertness, intellectual function and behavior of the research subjects, such as anticholinergic drugs and memory enhancer drugs, have been used or are expected to be used (except for cases where the dosage has been stable for at least 1 month before enrollment and the administration regimen has not been changed during the study period); 6. Have used any hypnotic drugs other than benzodiazepines within 7 days or less than 5 drug half-lives before enrollment; 7. New non-pharmacological treatments for insomnia (such as cognitive behavioral therapy, physical therapy, etc.) initiated within one week before the start of the conversion treatment; 8. One month before enrollment, the long-term and stable medication used for treating physical diseases or other mental disorders (including but not limited to drug types and dosages) has been adjusted, or/and it is expected that the medication regimen will need to be changed during the study period; 9. Women who are pregnant or breastfeeding; 10. Other circumstances where the researcher deems it unsuitable to participate in this clinical study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of switching drug treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep indicators;Evaluation of withdrawal rebound after the drug - reduction period;Safety indicators;Daytime function indicators; | — |
Countries
China
Contacts
Public ContactMa Qinying
The First Hospital of Hebei Medical University
Outcome results
None listed