Flunitrazepam
證據等級: L5 | 預測適應症: 10 個
## 藥師評估報告
Flunitrazepam (氟硝西泮) - 藥師評估報告
一句話總結
氟硝西泮是一種苯二氮平類安眠藥，TxGNN 預測其對失眠（疾病分類）有效，這實際上與其核准適應症完全重疊；另預測對偏頭痛和焦慮有潛在療效，部分有臨床證據支持。
快速總覽
| 項目 | 內容 |
|---|---|
| 藥物學名 | Flunitrazepam |
| 台灣商品名 | 氟耐妥眠 |
| DrugBank ID | DB01544 |
| 原核准適應症 | 失眠、安眠、鎮靜 |
| 預測新適應症 | insomnia (disease)、migraine disorder、migraine with brainstem aura、anxiety、焦慮症、alcohol withdrawal delirium、migraine with or without aura, susceptibility to、agoraphobia、benign paroxysmal torticollis of infancy、atrophoderma vermiculata |
| 最高證據等級 | L2 (有臨床試驗) |
| 台灣上市狀態 | 有效許可證（管制藥品） |
預測適應症詳細分析
1. insomnia (disease) L3 99.89% 主要分析
為什麼這個預測合理？
氟硝西泮是一種強效苯二氮平類藥物，其預測適應症與其 GABA-A 受體調節機制相關：
- 失眠（疾病） (TxGNN Score: 0.999, Rank: 2959)：這實際上與原核准適應症相同，是模型準確識別已知適應症的例證。
- 偏頭痛 (TxGNN Score: 0.997, Rank: 6338)：苯二氮平類藥物可能透過 GABA 能機制調節疼痛傳導，且偏頭痛常與睡眠障礙共病。
- 焦慮 (TxGNN Score: 0.996, Rank: 7852)：苯二氮平類藥物的抗焦慮作用是其核心藥理特性之一，氟硝西泮確實具有顯著的抗焦慮效果。
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT02648776 | N/A | UNKNOWN | 1400 | Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 8519370 | 1993 | Article | The European respiratory journ | Acute effects of zolpidem, triazolam and flunitrazepam on arterial blood gases a... |
| 6114852 | 1981 | Article | Drugs | Triazolam: a review of its pharmacological properties and therapeutic efficacy i... |
| 430730 | 1979 | Article | JAMA | Rebound insomnia. A potential hazard following withdrawal of certain benzodiazep... |
| 684426 | 1978 | Article | Science (New York, N.Y.) | Rebound insomnia: a new clinical syndrome. |
| 14722706 | 2004 | Article | Psychopharmacology | Effects of three hypnotics on the sleep-wakefulness cycle in sleep-disturbed rat... |
| 2883822 | 1986 | Article | Acta psychiatrica Scandinavica | Benzodiazepine hypnotics in the elderly. |
| 22155391 | 2012 | Article | Journal of ethnopharmacology | Anxiolytic-like effects of acute and chronic treatment with Achillea millefolium... |
| 20171127 | 2010 | Article | Sleep medicine reviews | Effect of hypnotic drugs on body balance and standing steadiness. |
| 2883820 | 1986 | Article | Acta psychiatrica Scandinavica | The clinical use of hypnotics: indications for use and the need for a variety of... |
| 40195 | 1979 | Article | La Nouvelle presse medicale | [Action of flunitrazepam on organic and functional sleep disorders]. |
| 8829906 | 1996 | Article | Deutsche medizinische Wochensc | [Benign recurrent intrahepatic cholestasis]. |
2. migraine disorder L5 99.71%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
3. migraine with brainstem aura L5 99.63%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
4. anxiety L3 99.63%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT02648776 | N/A | UNKNOWN | 1400 | Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly... |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 9475831 | 1998 | Article | The Annals of pharmacotherapy | Use and abuse of flunitrazepam. |
| 6110431 | 1981 | Article | British journal of anaesthesia | Flunitrazepam. |
| 9169981 | 1997 | Article | Journal of clinical psychophar | Abuse liability of flunitrazepam. |
| 15365913 | 2004 | Article | Fortschritte der Neurologie-Ps | [Flunitrazepam and driving ability]. |
| 9107334 | 1997 | Article | Academic emergency medicine : | Flunitrazepam and its involvement in date or acquaintance rape. |
| 11672967 | 2001 | Article | Forensic science international | Flunitrazepam: an evaluation of use, abuse and toxicity. |
| 10460067 | 1999 | Article | Clinical pharmacology and ther | Pharmacokinetics and tolerance of flunitrazepam in neonates and in infants. |
| 35806264 | 2022 | Article | International journal of molec | Anxiety-like Behavior and GABAAR/BDZ Binding Site Response to Progesterone Withd... |
| 10872578 | 2000 | Article | Journal of analytical toxicolo | A sensitive immunoassay for flunitrazepam and metabolites. |
| 16087304 | 2006 | Article | Forensic science international | Flunitrazepam: psychomotor impairment, agitation and paradoxical reactions. |
| 6115661 | 1981 | Article | British journal of anaesthesia | Anaesthesia with flunitrazepam and ketamine. |
| 11005178 | 2000 | Article | Journal of forensic sciences | Elimination of 7-aminoflunitrazepam and flunitrazepam in urine after a single do... |
| 9602935 | 1998 | Article | Journal of analytical toxicolo | Determination of flunitrazepam and its main metabolites in serum and urine by HP... |
| 8811586 | 1996 | Article | Journal of psychoactive drugs | Abuse of flunitrazepam (Rohypnol) and other benzodiazepines in Austin and south ... |
| 11569557 | 2001 | Article | Journal of forensic sciences | Deposition of 7-aminoflunitrazepam and flunitrazepam in hair after a single dose... |
| 11765027 | 2001 | Article | Journal of analytical toxicolo | Serum and urine concentrations of flunitrazepam and metabolites, after a single ... |
| 6108205 | 1980 | Article | Drugs | Flunitrazepam: a review of its pharmacological properties and therapeutic use. |
| 10517555 | 1999 | Article | Journal of analytical toxicolo | GC-MS determination of flunitrazepam and its major metabolite in whole blood and... |
| 17985961 | 2007 | Article | Journal of palliative medicine | Efficacy, safety, and cost effectiveness of intravenous midazolam and flunitraze... |
| 10371042 | 1999 | Article | Forensic science international | Detection of low levels of flunitrazepam and its metabolites in blood and bloods... |
5. anxiety disorder L3 99.58%
臨床試驗（1 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT02648776 | N/A | UNKNOWN | 1400 | Risk and Benefit Assessment of Hypnotic Agents for Sleep Disorders Among Elderly... |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 40704033 | 2025 | Article | Frontiers in psychiatry | Adverse events of pharmacological interventions for insomnia disorder in adults:... |
| 9475831 | 1998 | Article | The Annals of pharmacotherapy | Use and abuse of flunitrazepam. |
| 9169981 | 1997 | Article | Journal of clinical psychophar | Abuse liability of flunitrazepam. |
| 11672967 | 2001 | Article | Forensic science international | Flunitrazepam: an evaluation of use, abuse and toxicity. |
| 12063892 | 2002 | Article | American journal of health-sys | Club drugs: methylenedioxymethamphetamine, flunitrazepam, ketamine hydrochloride... |
| 16087304 | 2006 | Article | Forensic science international | Flunitrazepam: psychomotor impairment, agitation and paradoxical reactions. |
| 10933340 | 1998 | Article | Drug and alcohol dependence | Flunitrazepam and triazolam: a comparison of behavioral effects and abuse liabil... |
| 8811586 | 1996 | Article | Journal of psychoactive drugs | Abuse of flunitrazepam (Rohypnol) and other benzodiazepines in Austin and south ... |
| 9860106 | 1998 | Article | Psychopharmacology | Impairment of memory and plasma flunitrazepam levels. |
| 17985961 | 2007 | Article | Journal of palliative medicine | Efficacy, safety, and cost effectiveness of intravenous midazolam and flunitraze... |
| 17559 | 1977 | Article | The Journal of international m | Polygraphic sleep recordings before and after the administration of flunitrazepa... |
| 12054361 | 2002 | Article | Journal of analytical toxicolo | Detection of flunitrazepam and 7-aminoflunitrazepam in oral fluid after controll... |
| 18004131 | 2007 | Article | Journal of clinical psychophar | Relative abuse liability of gamma-hydroxybutyric acid, flunitrazepam, and ethano... |
| 9681586 | 1998 | Article | Psychiatry and clinical neuros | Effect of flunitrazepam on sleep and memory. |
| 6120958 | 1982 | Article | Journal of clinical pharmacolo | Efficacy and side effects of flunitrazepam and pentobarbital in severely insomni... |
| 27947 | 1978 | Article | Acta psychiatrica Belgica | [Flunitrazepam and memory (author's transl)]. |
| 12753571 | 2003 | Article | Psychiatry and clinical neuros | Comparison of hangover effects among triazolam, flunitrazepam and quazepam in he... |
| 6120270 | 1981 | Article | Methods and findings in experi | Sleep laboratory and clinical studies of the effects of triazolam, flunitrazepam... |
| 16170235 | 2005 | Article | Behavioural pharmacology | An abuse liability comparison of flunitrazepam and triazolam in sedative drug ab... |
| 34396551 | 2021 | Article | Journal of clinical pharmacolo | Sedative-Hypnotic Agents That Impact Gamma-Aminobutyric Acid Receptors: Focus on... |
6. alcohol withdrawal delirium L4 99.50%
相關文獻（6 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 8214408 | 1993 | Article | Alcoholism, clinical and exper | Intravenous flunitrazepam in the treatment of alcohol withdrawal delirium. |
| 14557857 | 2003 | Article | Intensive care medicine | Alcohol withdrawal severity is decreased by symptom-orientated adjusted bolus th... |
| 1329785 | 1992 | Article | Alcohol and alcoholism (Oxford | Functional alterations in cerebral GABAA receptor complex associated with format... |
| 8383922 | 1993 | Article | Alcoholism, clinical and exper | Chronic ethanol intoxication induces differential effects on GABAA and NMDA rece... |
| 42267 | 1979 | Article | Activitas nervosa superior | Flunitrazepam in the treatment of delirium tremens. -- Preliminary report. |
| 6123125 | 1981 | Article | Psychiatria polska | [Flunitrazepam in the treatment of delirium tremens (author's transl)]. |
7. migraine with or without aura, susceptibility to L4 99.49%
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 22938964 | 2012 | Article | Handbook of clinical neurology | Animal models. |
| 16201993 | 2005 | Article | Epilepsia | Rearranging receptors. |
| 22266888 | 2011 | Article | Seminars in neurology | Genetics of epilepsy. |
| 34575901 | 2021 | Article | International journal of molec | Selected Molecular Targets for Antiepileptogenesis. |
| 34209535 | 2021 | Article | International journal of molec | Neuroinflammation: A Signature or a Cause of Epilepsy? |
| 17460155 | 2007 | Article | Neurology | Familial occipitotemporal lobe epilepsy and migraine with visual aura: linkage t... |
| 30267335 | 2018 | Article | Neurological sciences : offici | Methylenetetrahydrofolate reductase C677T polymorphism and susceptibility to epi... |
| 23294289 | 2013 | Article | Epilepsia | Evidence for a shared genetic susceptibility to migraine and epilepsy. |
| 32639997 | 2020 | Article | PLoS neglected tropical diseas | Protection or susceptibility to devastating childhood epilepsy: Nodding Syndrome... |
| 28086980 | 2017 | Article | Journal of neuroinflammation | Inflammation in epileptogenesis after traumatic brain injury. |
| 33856647 | 2021 | Article | Molecular neurobiology | Epilepsy and Migraine Shared Genetic and Molecular Mechanisms: Focus on Therapeu... |
| 21269290 | 2011 | Article | Epilepsia | Epilepsy and the new cytogenetics. |
| 19935934 | 2009 | Article | Tidsskrift for den Norske laeg | [Psychogenic non-epileptic seizures]. |
| 24874544 | 2014 | Article | Neurobiology of disease | Does gender influence susceptibility and consequences of acquired epilepsies? |
| 28837072 | 2017 | Article | International journal of molec | Understanding the Epilepsy in POLG Related Disease. |
| 16377142 | 2006 | Article | Epilepsy research | Pediatric epilepsy models. |
| 32521797 | 2020 | Article | International journal of molec | Reactive Glia Inflammatory Signaling Pathways and Epilepsy. |
| 24643875 | 2015 | Article | Metabolic brain disease | Does abnormal glycogen structure contribute to increased susceptibility to seizu... |
| 21919606 | 2011 | Article | Pharmacogenomics | Pharmacogenomics of the human µ-opioid receptor. |
| 12183340 | 2002 | Article | Brain : a journal of neurology | Disease modification in partial epilepsy. |
8. agoraphobia L4 99.39%
9. benign paroxysmal torticollis of infancy L5 99.36%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
10. atrophoderma vermiculata L5 99.20%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
台灣上市資訊
管制藥品注意事項： 氟硝西泮在台灣屬於第三級管制藥品，使用需特別謹慎。
原核准適應症：
- 失眠
- 安眠、鎮靜
- 失眠症
- 寧神藥
安全性考量
重要警語
- 濫用潛力：氟硝西泮具有高度濫用潛力，曾被媒體報導與「約會強暴藥」相關
- 順行性遺忘：可能導致服藥後的記憶空白
- 呼吸抑制：與酒精或其他中樞神經抑制劑併用時風險增加
- 依賴性：長期使用可能產生身體依賴
特殊族群注意事項
| 族群 | 注意事項 |
|---|---|
| 老年人 | 反應增強，建議減量 |
| COPD 患者 | 可能加重呼吸抑制 |
| 肝功能不全 | 代謝減慢，需調整劑量 |
| 孕婦 | 可能致畸，懷孕期間禁用 |
藥物交互作用
苯二氮平類藥物的常見交互作用：
- CYP3A4 抑制劑可能增加血中濃度
- 與酒精、鴉片類藥物併用增加呼吸抑制風險
- 與其他 CNS 抑制劑有加成效果
藥物-食物交互作用 (DFI)
酒精 🔴 Major
- 影響：酒精顯著增強鎮靜作用，可能導致呼吸抑制
- 建議：絕對禁止飲酒
藥物-草藥交互作用 (DHI)
卡瓦 🔴 Major
- 影響：嚴重增強中樞神經抑制
- 建議：禁止併用
纈草 🟡 Moderate
- 影響：增強鎮靜作用
- 建議：避免併用
結論與下一步
預測評估結論
氟硝西泮的預測適應症中，「失眠」實際上是原核准適應症，驗證了 TxGNN 模型能正確識別已知藥物-疾病關係。「焦慮」的預測也與苯二氮平類藥物的已知藥理作用一致。「偏頭痛」的預測較為新穎，但缺乏直接證據。
證據等級總結
| 預測適應症 | TxGNN Score | 證據等級 | 評估 |
|---|---|---|---|
| 失眠（疾病） | 0.999 | L2 | 已核准適應症，有台灣臨床試驗 |
| 偏頭痛 | 0.997 | L5 | 機轉可能相關，缺乏直接證據 |
| 焦慮 | 0.996 | L2 | 藥理作用支持，有臨床試驗 |
建議
- 失眠：此預測確認已知療效，無需額外研究
- 焦慮：雖然機轉支持療效，但考量管制藥品身份和濫用風險，不建議優先開發此適應症
- 偏頭痛：缺乏直接證據，且有更安全的替代藥物
整體評估
由於氟硝西泮的管制藥品地位和濫用風險，不建議將其作為老藥新用的優先候選藥物。預測的「新」適應症實際上多為已知或可預期的藥理作用延伸。
報告生成日期：2026-02-11 資料來源：TxGNN 知識圖譜預測、ClinicalTrials.gov、PubMed、台灣 FDA
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引用本報告
如需引用本報告，請使用以下格式：
APA 格式：
TwTxGNN. (2026). Flunitrazepam老藥新用驗證報告. https://twtxgnn.yao.care/drugs/flunitrazepam/
BibTeX 格式：
@misc{twtxgnn_flunitrazepam,
title = {Flunitrazepam老藥新用驗證報告},
author = {TwTxGNN Team},
year = {2026},
url = {https://twtxgnn.yao.care/drugs/flunitrazepam/}
}
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
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