Safety and Efficacy Study of YZJ-1139 Tablets in Insomnia Disorder

Inclusion Criteria:

1. Males and females, aged ≥ 18 to < 65 years.

2. Meet the clinical diagnostic criteria for insomnia disorder as defined in ICSD-3criteria.

3. sTSO ≥ 30 min for at least 3 nights per week and/or sWASO ≥ 60 min for at least 3nights per week within 4 weeks prior to screening.

4. Able to recognize 26 English letters and MMSE score indicats no cognitiveimpairment.

5. During the run-in period and on Day 1 of the treatment period, sTSO ≥ 30 min for atleast 3 nights in the last 7 sleep diaries and/or sWASO ≥ 60 min for at least 3nights out of 7 nights as confirmed by the sleep diary prior to PSG monitoring.

6. PSG results for 2 consecutive nights during the run-in period should meet thefollowing conditions:

7. The mean LPS ≥ 30 min for 2 nights and ≥ 20 min for any one night; And/or themean WASO ≥ 60 min for 2 nights, and ≥ 45 min either night.

8. The mean SE ≤ 85% for 2nights, with the SE ≤ 87.5% for both nights .

9. ISI score ≥ 15 at screening and on Day 1 of the treatment period .

10. Have a bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m., andstay in bed for 6.5 to 9 hours for at least 5 nights in the last 7 sleep diaries asconfirmed by the sleep diary prior to PSG monitoring during the run-in period and onDay 1 of the treatment period.

11. Reproductive-age male and female participants must agree to use effectivecontraceptive measures from the screening visit through at least 30 days after thelast dose of double-blind study treatment, and must not be planning to becomepregnant or donate sperm/eggs during this period.

12. Understand the study procedures and contents, voluntarily participate in theclinical study and sign the written Informed Consent Form, have good complianceduring participation in the study, and are willing to attend the visits.

Exclusion Criteria:

1. Hypersensitivity to YZJ-1139 tablets or zolpidem or to their excipients.

2. Have serious endocrine diseases, hematological diseases, cardiovascular andcerebrovascular diseases, gastrointestinal diseases, liver and kidney diseases,autoimmune diseases, impaired respiratory function or other related diseases, orhave other medical history that may affect the safety of the subjects or interferewith the study assessments in the opinion of the investigator.

3. Have insomnia disorder due to other causes such as chronic pain, headache, eczema,neurodermatitis, allergic rhinitis, and serious dermatitis (difficulty sleeping dueto physical reasons, difficulty falling asleep due to medical reasons).

4. Current or previous history of psychiatric or neurological disease such as epilepsy,schizophrenia, bipolar mental disorder, neurodevelopmental retardation, andcognitive disorder, or previous history of other mental illness that may affect thesafety of the subjects or interfere with the study assessments in the opinion of theinvestigator.

5. Previous history of sleep-related respiratory disorders including obstructive sleepapnea (with or without continuous positive airway pressure [CPAP] therapy), periodiclimb movement disorder, myasthenia gravis, restless legs syndrome, circadian rhythmsleep disturbances, narcolepsy or other sleep disorders: subjects with restless legssyndrome which is diagnosed by relevant diagnostic and treatment guidelines shouldbe excluded. Those who have been cured of the above diseases can be enrolled.

6. Have previous complex sleep behaviors, such as sleep driving, sleep eating, andsleep phone calls.

7. Have nocturia increased caused by urinary tract infection, urinary tract injury orprostatic disorder.

8. Hyperthyroidism.

9. History of alcohol abuse (defined as regular daily alcohol consumption exceeding thefollowing criteria: approximately 720 mL of beer, or 240 mL of wine, or 60 mL ofliquor) within the past 6 months.

10. Regular daily consumption of excessive tea and coffee drinks (defined as consumptionof > 4 cups of caffeinated beverages or > 400 mg of caffeine per day), or dailyhabituation to drinking caffeinated beverages beyond 18:00.

11. Exclusion Criteria: Smokers who have smoked more than 10 cigarettes per day within 6months prior to screening or smokers who are unable to refrain from falling asleep.

12. Have any lifestyle that interferes with the study process or may interfere withsleep: for example, there will be travels across 3 or more time zones (mainlandChina is considered as 1 time zone) within the next 2 weeks or during the studyperiod, or there will be shift work (night and daytime shift).

13. History of drug abuse within the past 2 years, or positive urine drug screening forany indicator; history of drug taking or addiction, which is known throughquestioning.

14. Have received any hypnotics, antidepressants, antipsychotic drugs, anticholinergics,memory-enhancing drugs, antihistamines, centrally acting analgesics, centrallyacting muscle relaxants, central nervous system stimulants, CYP3A inducers, CYP3Ainhibitors, traditional Chinese medicines and traditional Chinese medicinal productswith sleep-improving effects, or any other therapies for insomnia disorder within 1week prior to the run-in period or within 5 half-lives of the investigationalproduct, whichever is longer.

15. Plan to undergo surgery during the study.

16. Depression: Hamilton Depression Scale (HAMD) score ≥ 18; anxiety: Hamilton AnxietyScale (HAMA) score ≥ 14.

17. Suicidal ideation with or without plan at screening or within 6 months prior toscreening (score ≥ 3 on item 3 [suicide] of HAMD, or select "Yes" on item 3, 4 or 5of suicidal ideation subscale of C-SSRS), or have any suicidal behavior in the past 10 years (as assessed by the suicidal ideation subscale of C-SSRS).

18. ECG at screening shows QTcF interval prolongation (QTcF > 450 ms,QTcF=QT/(RR^0.33)).

19. AST or ALT > 2 × the upper limit of normal (ULN), or Cr > 1.5 × ULN.

20. Known to be human immunodeficiency virus (HIV) antibody positive at screening.

21. Apnea-hypopnea index [AHI] or periodic limb movement index [PLMI] > 10 times/hourdetected by PSG monitoring during the run-in period.

22. Unable to avoid vaccination within 1 month prior to screening.

23. Enrolled in another clinical trial and used any investigational drug within 1 monthor 5 half-lives (whichever is longer) prior to the run-in period, or participationin another investigational trial at the same time during this trial.

24. Previously participated in any clinical trial of YZJ-1139; or treated with otherorexin receptor antagonists of appropriate amount and sufficient duration and who,in the opinion of the investigator, have failed treatment due to efficacy or safety.

25. Pregnant or lactating women.

26. Have other conditions that make the subject unsuitable for participation in theclinical study in the opinion of the investigator.