Auricular Acupuncture for Primary Insomnia

Auricular Acupuncture for Primary Insomnia

This double-blind RCT will evaluate the therapeutic effectiveness and safety of auricular acupuncture(AA) for primary insomnia(PI) .

Investigators will conduct a 2-year clinical trial on auricular acupuncture (AA) for primary insomnia (PI), which is a double-blind (patient-blind and assessor-blind) RCT. 288 patients will be randomly assigned into 2 groups: the treatment group (Group A) and the control group (Group B). Group A will be treated with AA plus oral Eszopiclone, while Group B will be treated with sham AA plus oral Eszopiclone. All patients will receive a continuous 4-week treatment and 28-week follow-up. The data will be analyzed by the third party who is not clear about allocation and treatment.

Inclusion Criteria:

• Meet the diagnosis of PI according to DSM-5;
• Aged 18-64 (including 18 and 64);
• Provided a signed written consent form.

Exclusion Criteria:

• The patient has somatic disease like severe respiratory, circulatory, endocrine system disease and hepatic/renal insufficiency;
• The patient suffers from moderate / major depression (BDI score ≧ 8 points), moderate / severe anxiety disorder (SAS score ≧ 61 points) or any other serious mental disease;
• The patient who abuse drug alcohol or substance;
• The patient suffers from dementia or any other severe cognitive impairment;
• The patient is in pregnancy or lactation period;
• Patient who is a night worker or stick to irregular sleep pattern, and can't or don't want to terminate this kind of work mode;
• The patient has history of suicide or suicidal tendency;
• The patient is allergic to Eszopiclone or any other sedative-hypnotic drugs;
• The patient who has taken psychiatric, hypnotic or antihistamine drugs during the last 4 weeks before baseline, however, the patient who use the prescription or nonprescription hypnotic drugs no more than twice a week can be recruited as soon as drug withdrawal;
• The patient who is receiving ongoing psychological treatment;
• The patient who has obstructive sleep apnea, restless leg syndrome, sleep rhythm disorders, parasomnias, etc.