失眠症藥物治療之新進展

The Pharmacotherapy of Insomnia

在當代臨床醫學中失眠症（insomnia disorder）已被視為獨立的疾病系統，國際分類（如DSM-5-TR、ICSD-3）以3個月病程作為慢性與短期失眠之分界。台灣慢性失眠盛行率達10.7%，健保安眠藥年處方量突破11億顆，傳統GABA-A受體正向異位調節劑（BzRAs）帶來的耐受性、生理依賴及年長者跌倒風險，引發公衛關切。隨神經科學突破，新興失眠治療藥物包括雙重食慾素受體拮抗劑（DORA）、褪黑激素受體促效劑、超低劑量組織胺H1受體拮抗劑，在多項大型第3期臨床試驗中，展現維持生理睡眠結構與高安全性的優勢。本篇綜述回顧最新失眠藥物學進展，提供台灣醫師作為失眠治療之用藥參考。

Insomnia disorder is now recognized as a distinct clinical entity in contemporary medicine. Current international diagnostic taxonomies, including the DSM-5-TR and ICSD-3, delineate chronic from short-term insomnia utilizing a three-month symptom duration threshold. In Taiwan, the prevalence of chronic insomnia is estimated at 10.7%, with the annual prescription volume for hypnotic agents under the National Health Insurance system exceeding 1.1 billion tablets. The widespread use of traditional gamma-aminobutyric acid type A (GABA-A) receptor positive allosteric modulators (BzRAs) has prompted substantial public health scrutiny due to associated adverse outcomes, notably pharmacological tolerance, physiological dependence, and an elevated risk of falls in the geriatric population. Following recent neuroscientific advancements, emerging pharmacotherapies—namely dual orexin receptor antagonists (DORAs), melatonin receptor agonists, and ultra-low-dose histamine H1 receptor antagonists—have demonstrated distinct advantages in preserving physiological sleep architecture while maintaining favorable safety profiles across multiple large-scale Phase III clinical trials. This review synthesizes the latest developments in insomnia pharmacotherapy to provide an evidence-based clinical reference for physicians in Taiwan regarding the contemporary management of insomnia.