{ "id": "ambien", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "AMBIEN", "generic": "酒石酸唑吡坦", "aliases": [ "AMBIEN", "zolpidem", "zolpidem tartrate", "唑吡坦", "酒石酸唑吡坦", "AMB 5", "AMB 10", "0024-5401-31", "0024-5421-31" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国：DailyMed 的有日期 AMBIEN 公开标签（SPL v26，2025-04-15 更新）列示酒石酸唑吡坦 5 mg、NDC 0024-5401-31 与 10 mg、NDC 0024-5421-31 的 100 片瓶装。该文件不建立中国大陆、欧盟、日本或其他市场的商品名、批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "dosageFormClass": "酒石酸唑吡坦薄膜衣口服片：每片 5 mg 或 10 mg（所引美国公开标签列示；均无刻痕）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1992（所引美国公开标签列示 Initial U.S. Approval）", "archiveSponsorText": "sanofi-aventis U.S. LLC（所引美国公开标签的品牌产品文件所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "AMBIEN CR", "zolpidem tartrate extended-release", "zolpidem extended-release", "唑吡坦缓释片", "other zolpidem package", "其他唑吡坦包装" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ambien-zolpidem-tartrate-tablet-5mg-100-bottle-ndc-0024-5401-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v26（2025-04-15 更新）", "en": "DailyMed SPL v26 (updated 15 Apr 2025)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0024-5401-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AMBIEN 酒石酸唑吡坦 5 mg、100 片瓶装", "en": "AMBIEN zolpidem tartrate 5 mg, 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ambien-02.jpg&setid=c36cadf4-65a4-4466-b409-c82020b42452&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸唑吡坦（每片）", "en": "Zolpidem tartrate (per tablet)" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、睡眠方案或调药规则", "en": "Labelled amount per tablet; not a personal tablet count, sleep plan or adjustment rule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "粉色", "en": "pink" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": { "zh": "AMB 5 / 5401", "en": "AMB 5 / 5401" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 5 mg、NDC 0024-5401-31、100 片瓶装展示面（Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-ambien-zolpidem-tartrate-tablet-10mg-100-bottle-ndc-0024-5421-31", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v26（2025-04-15 更新）", "en": "DailyMed SPL v26 (updated 15 Apr 2025)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0024-5421-31", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "AMBIEN 酒石酸唑吡坦 10 mg、100 片瓶装", "en": "AMBIEN zolpidem tartrate 10 mg, 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ambien-03.jpg&setid=c36cadf4-65a4-4466-b409-c82020b42452&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "酒石酸唑吡坦（每片）", "en": "Zolpidem tartrate (per tablet)" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人片数、睡眠方案或调药规则", "en": "Labelled amount per tablet; not a personal tablet count, sleep plan or adjustment rule" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 100, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊形", "en": "capsule-shaped" }, "imprint": { "zh": "AMB 10 / 5421", "en": "AMB 10 / 5421" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 10 mg、NDC 0024-5421-31、100 片瓶装展示面（Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-ambien-zolpidem-tartrate-tablet-5mg-100-bottle-ndc-0024-5401-31", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=ambien-02.jpg&setid=c36cadf4-65a4-4466-b409-c82020b42452&type=img", "alt": "AMBIEN 酒石酸唑吡坦 5 mg、NDC 0024-5401-31、100 片瓶装在美国 DailyMed 公开标签中的展示图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v26（2025-04-15 更新）", "presentation": "AMBIEN 酒石酸唑吡坦：每片 5 mg，NDC 0024-5401-31，100 片瓶装（美国有日期公开标签）。", "notice": "此图只对应所引美国 DailyMed 标签中的 AMBIEN、酒石酸唑吡坦 5 mg、NDC 0024-5401-31 与 100 片瓶装。它只帮助核对品牌、通用名、每片标示量、包装、外观和来源；不用于鉴定真伪，也不代表 10 mg、AMBIEN CR、缓释唑吡坦、其他唑吡坦包装、其他镇静安眠产品、其他市场、当前可得性、原研身份、相等性、可替代性或任何个人的服用、停用、联用、换药或分片方案。", "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 酒石酸唑吡坦 5 mg、NDC 0024-5401-31、100 片瓶装有日期美国公开标签面板（Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMBIEN／酒石酸唑吡坦说明书放大阅读：先分清准确片剂与 AMBIEN CR", "en": "AMBIEN label reading: distinguish the exact tablet from AMBIEN CR first" }, "summary": { "zh": "本模块只阅读所引美国 DailyMed 标签中的 AMBIEN、酒石酸唑吡坦、准确片剂、每片标示量、NDC、100 片瓶装、外形和警示。它不提供个人服用时间、片数、停用、联用、换药、分片或购买方案。", "en": "This module reads only AMBIEN, zolpidem tartrate, the exact tablet, labelled amount per tablet, NDC, 100-tablet bottle, appearance and warnings in the cited U.S. DailyMed label. It provides no individual timing, tablet count, stopping, co-use, switching, splitting or purchase plan." }, "checks": [ { "zh": "先同时核对 AMBIEN、酒石酸唑吡坦、5 mg 或 10 mg、实际 NDC、100 片瓶装、颜色、压印和目标市场。mg 是这个准确片剂的标示量，不是网页可转化为个人片数、睡眠方案、补用、加减或转换规则。", "en": "Check AMBIEN, zolpidem tartrate, 5 mg or 10 mg, the actual NDC, 100-tablet bottle, colour, imprint and target market together. mg is the labelled amount in an exact tablet, not a web rule for personal tablet count, sleep plan, make-up use, adjustment or conversion." }, { "zh": "所引标签中的 5 mg 和 10 mg 片均无刻痕。AMBIEN CR 或其他缓释唑吡坦不是这两组普通片身份的一部分；共同通用名、相近 mg、相似包装或“缓释”文字都不建立自行互换、掰开、压碎、叠加或替代关系。", "en": "Both 5 mg and 10 mg tablets in the cited label are unscored. AMBIEN CR or another extended-release zolpidem product is not part of either immediate-tablet identity; a shared generic name, nearby milligram number, similar package or extended-release wording does not establish self-switching, splitting, crushing, combining or substitution." }, { "zh": "标签含有“复杂睡眠行为”相关的方框警示，并提示可能造成严重伤害或死亡；也列有与酒精、其他中枢神经系统抑制性产品等共同出现时需要专业核对的内容。任何出现未完全清醒时的异常行为、受伤风险或即时安全担忧，应优先使用当地紧急医疗支持；不要依据网页自行用另一种安眠、镇静或止痛产品抵消、替代或组合。", "en": "The label has a boxed warning about complex sleep behaviours that may cause serious injury or death, and identifies alcohol and other central-nervous-system depressant products as matters for professional review. With an unusual behaviour while not fully awake, injury risk or an immediate safety concern, prioritise local urgent medical support; do not use this page to self-counteract, substitute or combine another sleep, sedating or pain product." }, { "zh": "标签特别提示老年人跌倒风险。头晕、意识混乱、跌倒、受伤、呼吸困难或其他急性令人担心的问题，需要把实际药盒、完整药单和情况交给当地医疗团队或药师；网页不能把年龄、睡眠描述、mg 或包装图变成继续、停用或换药决定。", "en": "The label specifically flags fall risk in older adults. With dizziness, confusion, a fall, injury, breathing difficulty or another acute worrying problem, take the actual pack, complete medicine list and circumstances to a local clinical team or pharmacist; a webpage cannot turn age, a sleep description, mg or a package image into a continue, stop or switching decision." } ], "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 酒石酸唑吡坦有日期美国公开标签（Boxed Warning, Warnings and Precautions；Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "酒石酸唑吡坦怎样起作用：标签中的 GABAA 受体阳性调节剂术语，不是个人睡眠用药方案", "en": "How zolpidem tartrate works: GABAA-receptor positive-modulator terminology in the label is not a personal sleep-medication plan" }, "summary": { "zh": "所引美国标签将酒石酸唑吡坦描述为咪唑并吡啶类 GABAA 受体阳性调节剂。这帮助读者理解标签术语；不解释个人失眠原因，也不判断是否应使用、与其他镇静安眠产品如何衔接、能否联用、何时改变或停止。", "en": "The cited U.S. label describes zolpidem tartrate as an imidazopyridine GABAA-receptor positive modulator. This helps readers understand label terminology; it does not explain an individual's insomnia, or decide whether to use it, how it relates to another sedating or sleep product, whether products can be combined, or when to change or stop." }, "checks": [ { "zh": "“作用于 GABAA 受体”或“安眠/镇静”都不是把 AMBIEN、AMBIEN CR、其他唑吡坦、苯二氮卓类、酒精、止痛药或非处方睡眠产品自行叠加、交替、替换或换算的依据。", "en": "“Acts at GABAA receptors” or “sleep/sedating” is not a basis for self-combining, alternating, substituting or converting AMBIEN, AMBIEN CR, another zolpidem product, a benzodiazepine, alcohol, a pain medicine or an OTC sleep product." }, { "zh": "机制页不能判断个人的睡眠问题、记忆改变、日间困倦、跌倒或意识变化是否由药物造成，也不能替代对年龄、既往反应、合并疾病、酒精/非处方产品和完整药单的专业核对。", "en": "A mechanism page cannot determine whether an individual's sleep issue, memory change, daytime drowsiness, fall or change in consciousness is medicine-related, nor replace professional review of age, prior reactions, coexisting conditions, alcohol/OTC products and the complete medicine list." }, { "zh": "出现未完全清醒时的异常行为、跌倒受伤、呼吸困难、意识改变或其他即时安全担忧时，应优先使用当地紧急医疗渠道；不要依据机制或包装文字自行改变多个产品。", "en": "With an unusual behaviour while not fully awake, a fall or injury, breathing difficulty, altered consciousness or another immediate safety concern, use local urgent medical pathways first; do not change several products yourself from mechanism or package text." } ], "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed（NLM）：AMBIEN 酒石酸唑吡坦有日期美国公开标签（Clinical Pharmacology；Sanofi；SPL v26）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "AMBIEN", "generic": "酒石酸唑吡坦", "dosageFormClass": "酒石酸唑吡坦薄膜衣口服片：每片 5 mg 或 10 mg（所引美国公开标签列示；均无刻痕）" }, "labelSource": { "id": "src_dc70521faf7d9d33", "label": "DailyMed (NLM): AMBIEN zolpidem tartrate dated U.S. public label (Sanofi; SPL v26, updated 15 Apr 2025)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "productRoutes": [ { "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed (NLM): AMBIEN zolpidem tartrate dated U.S. public label (Sanofi; SPL v26, updated 15 Apr 2025)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-25", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的有日期 AMBIEN（zolpidem tartrate）美国公开标签列示 5 mg、10 mg 两种薄膜衣口服片及对应 100 片瓶装。本页帮助读者把品牌、通用名、每片标示量、准确 NDC、无刻痕片、包装图、公开电子说明书和药物警戒阅读路径放在一起；不把毫克数、瓶数、睡眠问题或标签警示转换为个人服用时间、片数、联用、停用、换药、分片或购买结论。", "history": "所引 DailyMed 标签列示 Initial U.S. Approval: 1992，SPL v26 更新日期为 2025-04-15。5 mg、NDC 0024-5401-31 与粉色 AMB 5 / 5401 片，及 10 mg、NDC 0024-5421-31 与白色 AMB 10 / 5421 片，是两组分别记录的标签身份；AMBIEN CR、缓释唑吡坦、其他唑吡坦包装或其他镇静安眠产品须另按准确标签、剂型、包装与目标市场核对。", "sourceDocuments": [ { "id": "src_dc70521faf7d9d33", "label": "DailyMed (NLM): AMBIEN zolpidem tartrate dated U.S. public label (Sanofi; SPL v26, updated 15 Apr 2025)", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA official search", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed SPL setid c36cadf4-65a4-4466-b409-c82020b42452（v26；有日期美国公开标签记录）", "approvalTimeline": [ { "date": "1992", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1992。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1992. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed: AMBIEN zolpidem tartrate U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } }, { "date": "2025-04-15 updated public label (SPL v26)", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2025-04-15 updated public label (SPL v26) 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2025-04-15 updated public label (SPL v26) FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_dc70521faf7d9d33", "label": "DailyMed: AMBIEN zolpidem tartrate U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=c36cadf4-65a4-4466-b409-c82020b42452&version=26", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-25", "reviewedAt": "2026-08-25" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ambien/", "en": "https://origindrug.com/en/drugs/ambien/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }