| Eligibility |
Inclusion Criteria:
1. Male or female aged 18 (inclusive) to 70 (inclusive) years old;
2. ASA class of I-II;
3. With chronic insomnia refractory to conventional drugs in the past 3 months
(benzodiazepine receptor agonists and other drugs). Other drugs: melatonin, melatonin
receptor agonists, and traditional Chinese medicine;
4. Compliant with the diagnostic criteria of ICSD-3 chronic insomnia:
1. At least one of the following chief complaints: initial insomnia, difficulty in
sleep maintenance, early awakening, refusal to go to bed at an appropriate time,
and difficulty in falling asleep without nursing;
2. At least one of the following daytime symptoms: tiredness, short tempered,
work/study/social skills decreased;
3. Occurrence of the above symptoms at least 3 times per week and lasting for more
than 3 months;
5. Voluntarily adopt narcotic sleep and obtain the written informed consent form.
Exclusion Criteria:
1. With contraindications to deep sedation/general anesthesia or a history of past
sedation/anesthesia accidents;
2. With a history of allergy or contraindications to anesthetics;
3. With a medical history or evidence of any of the followings before screening/at
baseline, which may increase sedation/anesthesia risks:
1. History of cardiovascular diseases: uncontrolled hypertension [systolic blood
pressure (SBP) = 170 mmHg and/or diastolic blood pressure (DBP) = 105 mmHg
without treatment, or SBP > 160 mmHg and/or DBP > 100 mmHg despite
antihypertensive treatment], severe arrhythmia, heart failure, Adams-stokes
syndrome, New York Heart Association (NYHA) Class = III, severe superior vena
cava syndrome, pericardial effusion, acute myocardial ischemia, unstable angina,
myocardial infarction within 6 months before screening, history of
tachycardia/bradycardia requiring medical treatment, II-III degree
atrioventricular block (excluding patients with pacemakers);
2. History of respiratory system disorders: respiratory insufficiency, history of
obstructive pulmonary disease, history of bronchospasm requiring treatment within
3 months before screening, and acute respiratory tract infection with obvious
symptoms such as fever, wheezing, nasal obstruction, and cough within 1 week
before baseline;
3. History of neurological and psychiatric disorders: craniocerebral injury,
possible convulsions, myoclonus, intracranial hypertension, cerebral aneurysms,
history of cerebrovascular accidents; schizophrenia, mania, insanity, history of
cognitive disorder; history of epilepsy; mental disorder suggested by Mini
International Neuropsychiatric Interview (MINI);
4. History of gastrointestinal disorders: gastrointestinal retention, active
hemorrhage, or conditions that may lead to reflux and aspiration;
5. History of blood donation or blood loss of = 400 mL within 3 months before
screening;
4. With the following airway management risks at screening:
1. History of asthma or stridor;
2. Sleep apnea syndrome;
3. History or family history of malignant hyperthermia;
4. History of tracheal intubation failure;
5. Judged by investigators to have difficult airway or judged as difficult tracheal
intubation (modified Mallampati class IV) at screening;
5. Receipt of any of the following medications/therapies at screening/baseline:
1. Any clinical study within 1 month before screening;
2. Sedatives/anesthetics, and/or sedative-hypnotics within 72 h before baseline;
3. Antidepressants and anxiolytics within 14 days before baseline;
6. Laboratory test abnormalities at screening:
1. Total bilirubin > 2 × ULN (upper limit of normal);
2. Aspartate aminotransferase (AST) and alanine transaminase (ALT) > 2 × ULN;
3. Blood creatinine > 1.5 × ULN;
7. Unable to fast for 6 h before dose administration;
8. With a history of smoking, drug abuse and/or positive urine drug screening results, or
positive breath alcohol test results at baseline and/or a history of alcohol abuse
within 3 months before screening. Alcohol abuse is defined as an average of > 2 units
of alcohol consumed per day (1 unit = 360 mL of beer with 5% alcohol, 45 mL of liquor
with 40% alcohol, or 150 mL of wine);
9. Pregnant or breastfeeding females; women of child-bearing potential or men who are
unwilling to use contraception during the trial; or patients who are planning
pregnancy within 1 month after the trial (including male patients);
10. Unable to avoid engaging in dangerous occupations requiring concentration and/or motor
coordination 72 h after administration;
11. Judged by investigators to be unsuitable for participating in this trial for any
reason.
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