益肾养心安神片, Yishen Yangxin Anshen Pian, Yi Shen Yang Xin An Shen Pian, 24 tablets, Used for Insomnia

Drug Name
Yi Shen Yang Xin An Shen Pian
Yishen Yangxin Anshen Pian
Yishen Yangxin Anshen Tablets

Ingredients
Fried Ziziphi Spinosae Semen (Suanzaoren), Prepared Polygoni Multiflori Radix (Zhiheshouwu), Mori Fructus (Sangshen), Lilii Bulbus (Baihe), Salviae Miltiorrhizae Radix et Rhizoma (Danshen), Ganoderma (Lingzhi), Poria (Fuling), Anemarrhenae Rhizoma (Zhimu), Albiziae Flos (Hehuanhua), Chrysanthemi Flos (Juhua).

Description
This product is film-coated tablets. After removing the film coating, the tablets appear brownish-yellow to brown; it has a slight odor and a bitter taste.

Functions and Indications
Tonifies the kidney, nourishes the heart, and calms the mind. Used for insomnia classified as "heart-blood deficiency and kidney-essence insufficiency" in traditional Chinese medicine (TCM) differentiation. Symptoms include insomnia, polyphagia, palpitations, fatigue, forgetfulness, dizziness, and lumbar soreness. The tongue is pale red with a thin white coating, and the pulse is submerged, thin, or weak.

Specifications
Each tablet weighs 0.4 g (equivalent to 1.4 g of crude herbs).

Dosage and Administration
Oral administration. 4 tablets each time, 3 times daily. The recommended course of treatment is 4 weeks.

Adverse Reactions
Mild elevations in liver biochemical parameters were observed during clinical trials.

Contraindications
Contraindicated in individuals with hypersensitivity to this product or any of its ingredients.

Precautions

1. Use with caution in patients with liver disease or abnormal liver function. This product should not be used concomitantly with other hepatotoxic drugs. Monitor liver function tests during treatment; discontinue use and seek medical attention if abnormalities occur.
2. The safety and efficacy of this product have not been established in pregnant women, lactating women, or children.
3. Clinical trials have not evaluated the safety and efficacy beyond the recommended dosage and duration stated in the package insert.

Clinical Trials
This product was approved for clinical trials by the National Medical Products Administration (NMPA) in April 2009. Phase II and III clinical trials were conducted from January 2011 to February 2014. The trials adopted a multi-center, randomized, double-blind, placebo-controlled design. Phase II enrolled 237 subjects (119 in the treatment group, 118 in the placebo group). Phase III enrolled 480 subjects (360 in the treatment group, 120 in the placebo group).

Phase III Inclusion Criteria:

• Adults aged 18-65 years diagnosed with insomnia classified as "heart-blood deficiency and kidney-essence insufficiency" in TCM.
• Exclusion of secondary insomnia caused by other diseases, medications, environmental factors, or lifestyle habits.
• No use of central nervous system-acting drugs (e.g., hypnotics, antidepressants, anxiolytics) or psychotherapy/physical therapy within the past 2 weeks.

Trial Design:

• Screening phase: 1 week (both groups received placebo).
• Treatment phase: 4 weeks (treatment group received this product; placebo group received placebo).
• Follow-up phase: 4 weeks (discontinuation of treatment and placebo).

Dosage: 4 tablets, 3 times daily.

Primary Efficacy Outcome (Phase III):

• Sleep Disturbance Rating Scale (SDRS) total score reduction rate after 4 weeks of treatment:
  • Treatment group: 57.11% (adjusted mean).
  • Placebo group: 19.07% (adjusted mean).
  • Difference: 38.04% [95% CI (32.87%, 43.20%)], with the lower limit exceeding the superiority margin of 20% (p < 0.0001).

Secondary Efficacy Outcomes:
Improvements were observed in sleep quality parameters (sleep latency, sleep maintenance, early morning awakening, total sleep time, polyphagia), Pittsburgh Sleep Quality Index (PSQI) total score, TCM syndrome scores, and individual symptom scores (p < 0.05 vs. placebo).

Safety Outcomes:

• Among 478 subjects in the safety dataset (Phases II and III), 13 subjects (2.72%) in Phase III experienced mild, simultaneous elevations in ≥2 liver function parameters.

Pharmacology and Toxicology
Non-clinical pharmacodynamic studies demonstrated that oral administration of this product reduced spontaneous locomotor activity in mice, prolonged pentobarbital sodium-induced sleep duration, and increased the percentage of mice exhibiting sleep at sub-hypnotic pentobarbital sodium doses.

Storage
Store in a sealed container.

Packaging
PVC/PVDC blisters with aluminum foil packaging. 2 × 12 tablets per plate/box.

Expiration
36 months.