Insomnia
Conditions
Interventions
Experimental group:Zaleplon capsules 10 mg taken orally every night before bed for 4 weeks.
Control Group:Alprazolam tablets 0.2-0.4 mg orally every night before bedtime for 4 weeks.
Sponsors
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18 years old=50 kg, female body weight >=45 kg; 3. Meet the diagnostic criteria for insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5): A. Complaint of dissatisfaction with the quantity or quality of sleep with 1 (or more) of the following related symptoms: i. Difficulty falling asleep; ii. Difficulty maintaining sleep, which is characterized by frequent awakening or difficulty falling asleep after waking up; iii. Wake up early and can't fall asleep again. B. The sleep disorder causes clinically significant distress or results in social, occupational, educational, academic, behavioral, or other important functional impairment. C. Difficulty sleeping at least 3 nights per week. D. Sleep difficulties for at least 3 months. E. Difficulty sleeping despite adequate sleep opportunities. F. Insomnia is not better explained by other sleep-wake disorders and does not appear only in the course of other sleep-wake disorders (e.g., narcolepsy, breathing-related sleep disorders, circadian sleep-wake disorders, abnormal sleep). G. Insomnia cannot be attributed to the physiological effects of a substance (e.g., drugs of abuse, drugs). H. Coexisting psychiatric and somatic disorders do not adequately explain complaints of insomnia. 4. PSQI > 7 points; 5. Impairment of any of the following cognitive function assessments: A. MemTrax memory test accuracy <=80% B. The standard score of the connection test is < 40 points C. Symbol coding standard score < 40 points D. Continuous operation standard score < 40 points E. The standard score for digital breadth is < 40 points 6. Education level: junior high school or above; 7. Subjects and their guardians fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Meet other Axis I diagnostic criteria in DSM-5 (anxiety disorder, depressive disorder, bipolar disorder, obsessive-compulsive disorder, schizophrenia, mental retardation, etc.); 2. GAD-7>=15 or PHQ-9>=20 at baseline; 3. Use of antipsychotics, antidepressants, anxiolytics, and emotional stabilizers within 1 month before screening; 4. Patients who have received benzodiazepines and/or continuous non-benzodiazepine sedative-hypnotic drugs (zopiclone, dexzopiclone, zolpidem, zaleprolone, at least 2 weeks of treatment) within 2 weeks before screening, and the efficacy is not good; 5. Those who have serious or unstable cardiovascular, respiratory, hepatic, renal, hematological, endocrine, nervous system or other system diseases; 6. Presence of obstructive sleep apnea or restless legs syndrome, REM sleep behavior disorder, hypersomnia disorder, and any disease state that may affect the results of the study; 7. Subjects who may be allergic to any component of this drug or analogues; 8. Those who have been selected for other clinical trials within 3 months before screening, or are participating in clinical trials; 9. Those who cannot cooperate with relevant inspections; 10. Pregnant or lactating women; 11. Men and women of childbearing age who are unwilling to use contraception during the study; 12. Other conditions that the investigator believes are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive function; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;7-item Generalized Anxiety Disorder Scale score;9 patient health questionnaire depression screening scale scores;The MOS item short from health survey;Fatigue Severity Scale score;Arizona Sexual Experience Scale score;Event-related potential;Polysomnography; | — |
Countries
China
Contacts
Public ContactYan Sun
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
Outcome results
None listed