Study on Ciprofol Injection in the Treatment of Patients with Chronic Insomnia Disorder

INTERVENTION: Intervention group:Cyclopentolol injection is administered; the initial loading dose is 0.6±0.2 mg/kg, given once per minute. The MOAA/S score is monitored, and if this score is greater than 1 after 3 minutes, an additional dose of 0.2 mg/kg is given, with a maximum of 2 such additions, until the MOAA/S score drops to or below 1 – at that point the induction phase is completed. The maintenance dose ranges from 0.4 to 1.2 mg/(kg·h), starting at 0.4 mg/(kg·h), with adjustments made based on the PSG parameters during the procedure as well as the patient’s vital signs.Criteria and timing for terminating a single treatment session: If sleep in the N3 stage can be induced, administration of the drug is stopped after 60 minutes at the maintained dose once the patient is in the N3 stage. If sleep in the N3 stage cannot be induced during the induction phase, then the drug is discontinued after 60 minutes at the maintained dose once the patient is in a stable N2 stage of sleep.;Control group:Infusion of medium/long‐chain fat emulsion solution was carried out at a rate of 25–30 ml/h. Treatment began at the same time as in the experimental group, and it was stopped after 60 minutes of infusion. The timing and criteria for ending a single treatment session were the same as those used in the experimental group.; CONDITION: Chronic insomnia PRIMARY OUTCOME: Insomnia Severity Index (ISI); SECONDARY OUTCOME: Polysomnography (PSG);Vital signs [blood pressure (BP), including systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and respiratory rate (RR)], pulse oxygen saturation (SpO2), physical examina;Abuse/dependence potential of anesthetic drugs;Use of baseline concomitant medications;ncidence and severity of adverse events (AE);Pittsburgh Sleep Quality Inde X(PSQI);Hamilton Depression Rating Scale (HAMD);Hamilton Anxiety Rating Scale (HAMA); INCLUSION CRITERIA: 1.Age 18–64 years (inclusive), gender unrestricted. 2.Subjects must have a full understanding of the trial content, procedures, and possible adverse reactions, voluntarily sign the informed consent form, voluntarily receive treatment with intravenous anesthetic drugs, and be willing and able to cooperate and complete the study protocol from the screening period through the 3‐month follow‐up period. 3.Male body weight >= 50 kg, female body weight >= 45 kg body mass inde X(BMI = weight/height² [kg/m²]) within the range 18–35 kg/m² (inclusive). 4.Meet the diagnostic criteria for insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM‐5) chronic insomnia with a disease duration of more than 2 years, recurrent symptoms, and inadequate response to treatment with two or more different classes of medications within 3 months prior to enrollment. 5. Insomnia Severity Inde X(ISI) score >= 15 at screening.