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Current reliance on preclinical evidence underscores the urgent need for rigorous clinical trials

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The mechanisms of action involve modulation of sleep-regulating neurotransmitters and neuroendocrine systems including enhancement of delta wave activity during deep sleep stages, regulation of cortisol and stress hormone rhythms that impact sleep quality, optimization of circadian rhythm signaling for proper sleep-wake cycles, support for melatonin and sleep-promoting pathways, and modulation of pain perception which can interfere with sleep quality