Shugan Jieyu Capsule for Insomnia Patients With Depressive Symptoms

Inclusion Criteria:

• Conform to DSM-5 diagnostic criteria for insomnia.
• Moderate or above depressive symptoms: patient health questionnaire depression scale (PHQ-9) ≥ 10 points.
• No drug treatment for insomnia and/or depression within one month before the start ofthis study.
• 18-60 female or male.
• Can understand and comply with the research protocol, and can sign a written informedconsent.

Exclusion Criteria:

• Shift workers, perennial night shift workers, frequent cross time zone pilots (such ascrew members of international flights).
• PSG examination revealed sleep apnea syndrome (Apnea Hypopnea Index, AHI) ≥ 15 timesone hour) and/or periodic limb movement disorder (periodic Limb Movement Index, PLMI] ≥ 15 times one hour).
• Those who have serious heart disease (such as heart failure, acute myocardialinfarction, arrhythmia, coronary heart disease), liver disease (such as hepatitis,cirrhosis, liver cancer, alcoholic liver), lung disease (such as asthma, acutepneumonia, tuberculosis, lung cancer), kidney disease (such as acute and chronicglomerulonephritis, nephrotic syndrome) and other systemic diseases (such as diabetes)that need treatment.
• Have previously diagnosed mental disorders.
• Comply with DSM-5 diagnostic criteria for depression
• Allergic constitution, known or suspected of hypericum perforatum, acanthopanaxsenticosus and zolpidem allergy history.
• The past used of zolpidem or Shugan Jieyu capsule was ineffective.
• Liver function test ALT, AST>2 times the upper limit of reference value, or Scr>theupper limit of reference value.
• The P450 3A4 inhibitors of liver metabolic cytochrome enzyme have been used within 14days before randomization, including but not limited to: ketoconazole, itraconazole,fluconazole, erythromycin, clarithromycin, acezotocin, indinavir, nafinavir, linavir,fluvoxamine, and saquinavir.
• The P450 3A4 inducer of liver metabolic cytochrome enzyme has been used within 14 daysbefore randomization, including but not limited to phenytoin, carbamazepine,barbiturates, rifampicin, St. John's wort, and glucocorticoids.
• Substance or alcohol dependence (except complete remission and caffeine or nicotinedependence) according to DSM-IV standard at the time of inclusion.
• The abuse of opioids, amphetamines, barbiturates, cocaine, cannabis or hallucinogensaccording to DSM-IV standards 4 weeks before enrollment.
• Medical conditions that affect the absorption, distribution, metabolism or excretionof the study drug.
• Participated in clinical research of other drugs 4 weeks before enrollment or longerbefore enrollment according to actual requirements.
• Pregnant or lactating women.
• Those who committed serious suicide or committed suicide planning.
• Other situations unsuitable for inclusion in the study.