insomnia
Conditions
Interventions
YZJ - 1139 group:drug
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years old; 2. Meets the ICSD-3 criteria for chronic insomnia disorder; 3. PSG results of two nights at run-in period meet the following conditions: 1) latency of persistent sleep (LPS) average>=30min, with either night>=15min; 2) and/or wake after sleep onset (WASO) average >=30min, with either night>=20min; 3) sleep efficiency (SE) average <=85% with either night <=87.5%; 4. During the study, patients are willing to follow a regular bedtime between 21:00 and 24:00 and regular time in bed between 6.5 and 9.0 hours, and refrain from napping; 5. Female subjects must have a negative pregnancy test at screening. Male and female of childbearing potential agree to use medically approved effective contraception during the study and for one month after the end of the study. 6. Understands the procedure and content of the study, willing to participate in the clinical trial and sign written informed consent, and has good compliance.
Exclusion criteria
Exclusion criteria: 1. Sleep disorders associated with neurological disease, such as depression, anxiety, and dementia; Depression: HAMD score >=18 or item 3 (suicidal idea) score 3 or aboveAnxiety: HAMA score >=14; Dementia: MMSE score 10 times/hour at the run-in PSG; 3. Patients with serious endocrine diseases, blood diseases, cardiovascular and cerebrovascular diseases, autoimmune diseases, impaired respiratory function, etc. 4. History of neurological diseases, such as epilepsy, schizophrenia, bipolar disorder, neurodevelopmental delay, cognitive impairment, narcolepsy, restless leg syndrome, etc. 5. Has taken any hypnotic, antidepressant, antipsychotic, anticholinergic, memory-enhancer, antihistamine, CYP3A inducer, CYP3A inhibitor within the 2 weeks prior to run-in PSG; 6. History of drug abuse or addiction; 7. Any lifestyle that may interfere with patients study process or sleep, such as travel across the zones or shift work (day and night shifts); 8. The special professionals who need to operate machinery during the trial, such as professional drivers, altitude operators; 9. Has taken any other approved or experimental insomnia drugs prior to the study, including other orexin receptor antagonists, specific herbal preparations, traditional Chinese medicines, and continue to use during the study. 10. AST, ALT >1.2 ULN , or Cr >ULN , or leukocyte < LLN; 11. Patients with hyperthyroidism or hypothyroidism; 12. History of alcohol abuse (defined as regular drinking alcohol per day: approximately beer 720ml, wine 240ml , or white wine 60ml); 13. History of drug abuse, or urine drug screen (screening and/or baseline) is positive for any index; 14. Excessive drinks tea or coffee regularly every day; 15. Participated in other clinical trials within the past 3 months or during this trial; 16. Pregnant or lactating female; 17. History of allergy to the study drug or the components; 18. Any other conditions that the investigator deems unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep efficiency; | — |
Secondary
| Measure | Time frame |
|---|---|
| TST;LPS;WASO;NAW; | — |
Countries
China
Contacts
Public ContactTAOTAO JIANG
Shanghai Haiyan Medical Technology Co., LTD
Outcome results
None listed