抗憂鬱藥物治療失眠之適當性評估

The Appropriateness of the Insomnia Treatment Using Antidepressant Drugs

鍾慧(Huei Chung) ； 楊瑛碧(Ying-Pi Yang) ； 譚延輝(Yen-Huei Tarn)

《長期照護雜誌》 17卷2期 (2013/08) Pp. 97-104

https://doi.org/10.6317/LTC.201308_17(2).0004

摘要

目的：探討抗憂鬱藥物治療失眠的適當性。方法：以insomnia、antidepressant、off label、trazodone等關鍵字於PubMed及Cochrane Library資料上搜尋，利用人工閱讀的方式，選出適合且相關的研究論文，最後共計有4篇文獻納入討論。結果：目前只有doxepin取得美國食品藥物管理局核准適應症使用在治療失眠，其他藥品則是以非核准適應症使用（off-label use）在治療失眠，因此需要更進一步評估及探討是否有足夠文獻佐證療效與安全。Amitriptyline及nortriptyline屬於tricyclic antidepressant（TCA），因為年長者對於抗膽鹼副作用的耐受性差，因此American Geriatrics Society（AGS）Beers criteria建議避免使用在年長病患。Trazodone在低劑量時就有很好的鎮靜效果且副作用少，在核准zolpidem上市前，常見在臨床上以非核准適應症或是輔助方式治療失眠，但是有關療效及安全性的實證上，還是相對不足。結論：非核准適應症使用藥品在醫療行為中並非禁止的行為，但是否有足夠療效及安全性證據支持，乃為值得關注的議題。目前抗憂鬱藥物的非核准適應症使用在治療失眠上，需要更多良好設計之臨床試驗，以支持其使用。在臨床使用治療年長病患失眠時，需考慮病患其他共同疾病以及藥物來選擇適合之安眠治療藥品。

關鍵字

失眠 ； 抗憂鬱藥物 ； 非核准適應症使用

並列摘要

Purpose: To discuss the appropriateness of the insomnia treatment using antidepressant drugs. Method: Research papers were searched through PubMed and Cochrane Library database using the keyword ”insomnia”, ”antidepressant”, ”off label”, ”trazodone”. Four papers were selected and critically appraised. Results: Only doxepin obtained the approved indications in the treatment of insomnia from the US Food and Drug Administration, other drugs are off-label use in the treatment of insomnia. The appropriateness of this off-label use needs further evaluation and more scientific evidences on insomnia efficacy and safety should exist to support its use. Both amitriptyline and nortriptyline are tricyclic antidepressants (TCA). Elderly people have poor tolerance to that category of drugs because of their strong anticholinergic side effects and Beers criteria from American Geriatrics Society (AGS) recommended not to use in the elderly patients. Trazodone at low doses has a good sedative effect and fewer side effects. Before zolpidem launched on the market, trazodone was wildly used as the treatment for insomnia. However, there are lacks of evidence on efficacy and safety. Conclusion: In medical practice, off-label use of drugs is not prohibited. However, lack of strong evidences to support decision making may be an issue of concern at current medical practice. The off-label use of antidepressants for the treatment of insomnia may need better designed researches to prove the appropriate use clinically, especially in the elderly population.

並列關鍵字

insomnia ； antidepressant drugs ； off-label use