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about 7.1 mm diameter and 3.3 mm thick; unscored" }, "imprint": "LЄM 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "jp-dayvigo-lemborexant-10mg-tablet-30200amx00019000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2025-12-10 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised 10 Dec 2025; verified 30 Aug 2026)" }, "dosageForm": { "zh": "デエビゴ 莱博雷生口服薄膜衣片", "en": "DAYVIGO lemborexant oral film-coated tablet (Japan)" }, "route": { "zh": "口服（日本准确产品身份字段）", "en": "oral (exact Japanese product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "PMDA 30200AMX00019000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片莱博雷生 10 mg；日本 PMDA 产品身份", "en": "Lemborexant 10 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "莱博雷生（レンボレキサント）", "en": "lemborexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、年龄对应方案或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "准确包装数量未在本身份卡中建立", "en": "exact pack count not established in this identity card" }, "fill": null, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "active_regulatory_record", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": { "color": { "zh": "橙色", "en": "orange" }, "shape": { "zh": "圆形薄膜衣片；直径约 7.1 mm、厚约 3.3 mm；无刻痕", "en": "round film-coated tablet; about 7.1 mm diameter and 3.3 mm thick; unscored" }, "imprint": "LЄM 10", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-dayvigo-lemborexant-5mg-30-tablet-bottle-ndc-6285640530", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dayvigo-05.jpg&setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "alt": "DAYVIGO 莱博雷生 5 mg、NDC 62856-405-30、30 片瓶装在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v39（2025-02 更新）", "presentation": "DAYVIGO 5 mg、NDC 62856-405-30、30 片瓶装标签展示面", "notice": "此图只对应美国当前标签中的 DAYVIGO 5 mg、NDC 62856-405-30、30 片瓶装。它不代表日本包装、BELSOMRA、QUVIVIQ、AMBIEN、通用药、库存或可购买资格，不用于鉴定真伪或生成个人服用安排。日本三种产品本页只保留 PMDA 文字身份，不借用美国包装图。", "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "DAYVIGO 说明书放大阅读：先核对每片 mg，再看次日清醒、跌倒与完整药单", "en": "DAYVIGO label reading: check mg per tablet, next-day alertness, falls and the full medicine list" }, "summary": { "zh": "美国 5、10 mg 与日本 2.5、5、10 mg 是每片莱博雷生的标签标示量，不是网页给出的个人服用方案。酒精、阿片类、其他安眠镇静药和其他中枢抑制药可能叠加嗜睡、反应变慢、呼吸或跌倒风险。", "en": "U.S. 5 and 10 mg and Japanese 2.5, 5 and 10 mg figures are labelled lemborexant amounts per tablet, not a personal regimen supplied by this site. Alcohol, opioids, other sleep or sedative medicines and other CNS depressants can add drowsiness, slowed reactions, breathing or fall risk." }, "checks": [ { "zh": "包装上的 mg 只帮助识别强度，不等于应该吃几片。美国和日本的产品强度与标签文字不同；网页不会从年龄、失眠时长或市场自动生成个人片数、服用时间或漏服补服方案。", "en": "The pack mg identifies strength and is not a tablet count. U.S. and Japanese strengths and label wording differ; this site does not generate an individual tablet count, timing or missed-use action from age, insomnia duration or market." }, { "zh": "莱博雷生可能影响次日清醒、注意力、驾驶和运动协调。老人早晨仍明显困倦、站立不稳或发生跌倒时，不要驾车、操作危险设备、追加另一种安眠药或饮酒，应及时联系专业人员核对。", "en": "Lemborexant can affect next-day alertness, attention, driving and motor coordination. If an older adult remains markedly drowsy, unsteady on standing or has a fall, do not drive, operate hazardous equipment, add another sleep medicine or use alcohol; seek timely professional review." }, { "zh": "梦游、睡眠驾驶、在未完全清醒时进食、打电话或做其他事情属于复杂睡眠行为警讯。若发生，应先确保安全并立即联系开方团队；受伤、意识异常、呼吸困难或其他急性危险应使用当地急救支持。", "en": "Sleep-walking, sleep-driving, eating, making calls or other activities while not fully awake are complex-sleep-behaviour warnings. Secure safety and contact the prescriber immediately; injury, altered awareness, breathing difficulty or another acute danger requires local emergency support." }, { "zh": "睡眠瘫痪、入睡或醒来时出现幻觉样体验，或短暂腿部无力都应记录发生时间和同服药物并联系专业人员。网页不能用这些表现替个人诊断，也不能据此自行加量、减量或停药。", "en": "Sleep paralysis, hallucination-like experiences around sleep or waking, or temporary leg weakness should be recorded with timing and co-medications and reviewed professionally. The site cannot diagnose from these events or direct an individual increase, decrease or stop." }, { "zh": "酒精、阿片类、苯二氮䓬类、抗过敏药及其他中枢抑制药可能叠加风险；强或中度 CYP3A 抑制剂及诱导剂也会影响专业安排。请带上处方药、非处方药、保健品和完整药单逐项核对。", "en": "Alcohol, opioids, benzodiazepines, allergy medicines and other CNS depressants can add risk. Strong or moderate CYP3A inhibitors and inducers can also affect professional management. Bring prescription medicines, OTC products, supplements and the full list for item-by-item review." }, { "zh": "DAYVIGO、BELSOMRA 与 AMBIEN 是不同药物。即使都用于睡眠，或 DAYVIGO 与 BELSOMRA 同属双食欲素受体拮抗剂，也不能按 mg 换算、自行隔天轮换、叠加或用剩药替换。", "en": "DAYVIGO, BELSOMRA and AMBIEN are different medicines. Even though they may be used for sleep, and DAYVIGO and BELSOMRA are both dual orexin-receptor antagonists, they cannot be converted by mg, self-rotated on alternate days, combined or substituted with leftovers." } ], "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "莱博雷生怎样作用：阻断 OX1R 与 OX2R 食欲素受体，减弱促清醒信号", "en": "How lemborexant works: blocking OX1R and OX2R orexin receptors to reduce wake signalling" }, "summary": { "zh": "莱博雷生是双食欲素受体拮抗剂，可结合 OX1R 与 OX2R，抑制食欲素系统的促清醒信号。通俗地说，它减弱一条维持清醒的信号，而不是把所有神经活动‘关掉’；这个机制不能预测个人是否适合、应选多少 mg 或能否与其他安眠镇静药叠加。", "en": "Lemborexant is a dual orexin-receptor antagonist that binds OX1R and OX2R and suppresses wake-promoting orexin signalling. In plain language, it reduces one wake-maintaining signal rather than ‘switching off’ all brain activity. This mechanism cannot predict individual suitability, strength choice or safe combination with another sleep or sedative medicine." }, "checks": [ { "zh": "同属双食欲素受体拮抗剂不表示 DAYVIGO、BELSOMRA 与 QUVIVIQ 是同一种药，也不允许按毫克数一比一替换、叠加或轮换。", "en": "Membership in the dual orexin-receptor-antagonist class does not make DAYVIGO, BELSOMRA and QUVIVIQ one medicine or permit one-for-one milligram substitution, combination or rotation." }, { "zh": "与 AMBIEN 等其他作用机制的睡眠药不同，也不表示哪一种对所有人更好。完整药单、次日活动需求、跌倒与呼吸风险及专业评估都会影响个人安排。", "en": "A different mechanism from AMBIEN and other sleep medicines does not make one better for everyone. The full medicine list, next-day activity needs, fall and breathing risks and professional assessment can all affect individual management." }, { "zh": "机制用于理解药理和相互作用边界，不用于从睡眠时长或症状自行诊断病因、选药、决定片数或忽略次日困倦与复杂睡眠行为等完整标签警示。", "en": "Mechanism helps explain pharmacology and interaction boundaries; it does not diagnose the cause from sleep duration or symptoms, select treatment, set a tablet count or displace full label warnings such as next-day drowsiness and complex sleep behaviours." } ], "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "DAYVIGO", "generic": "莱博雷生", "dosageFormClass": "口服薄膜衣片；美国 5 mg、10 mg，30 或 90 片瓶装，C-IV 管制药物；日本 2.5 mg、5 mg、10 mg。市场、强度、包装与标签必须分别阅读" }, "labelSource": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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." } }, { "source": { "id": "src_28bcb721fcadb9cd", "label": "日本 PMDA：デエビゴ 2.5/5/10 mg 当前电子说明书（2025-12-10 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_1190027F1022_1_08", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "PMDA", "en": "PMDA" }, "market": { "zh": "日本", "en": "Japan" }, "recordType": { "zh": "监管产品记录", "en": "Regulatory product record" }, "reviewedAt": "2026-08-30", "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": "2026-08-30", "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": "DAYVIGO 是莱博雷生口服片的美国品牌，日本使用デエビゴ。美国当前标签展示 5、10 mg 的 30 片与 90 片瓶装。本页优先帮助老人和家属核对每片 mg、次日清醒与驾驶、嗜睡跌倒、复杂睡眠行为、酒精及其他中枢抑制药、CYP3A 相互作用；不生成个人片数、服用时间、补服、停药或换药方案。", "history": "FDA 于 2019 年批准 NDA 212028；美国当前标签将 DAYVIGO 列为 C-IV 管制药物。日本 PMDA 当前记录列 2.5、5、10 mg 产品并提供专业说明书和患者指南。批准史和各市场强度差异不能作为跨市场自行选规格或换算片数的依据。", "sourceDocuments": [ { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b349d6bcc5f44eb8", "label": "FDA：DAYVIGO（lemborexant）NDA 212028 初始批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_694bcc8d39732179", "label": "FDA：DAYVIGO 莱博雷生 NDA 212028 多学科审评资料", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000MultidisciplineR.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_13c9750dcadf9a09", "label": "FDA：DAYVIGO NDA 212028/S-008 补充批准函（2023）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212028Orig1s008ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_28bcb721fcadb9cd", "label": "日本 PMDA：デエビゴ 2.5/5/10 mg 当前电子说明书（2025-12-10 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170033_1190027F1022_1_08", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_ded1021170e392dd", "label": "日本 PMDA：デエビゴ 2.5/5/10 mg 患者向医药品指南", "url": "https://www.info.pmda.go.jp/downfiles/ph/GUI/170033_1190027F1022_1_00G.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_ac995c69dc1381b5", "label": "日本 PMDA：デエビゴ（lemborexant）新药审评报告", "url": "https://www.pmda.go.jp/drugs/2020/P20200203001/170033000_30200AMX00017_A100_1.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_review", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 212028（DAYVIGO / lemborexant tablets）；日本 PMDA 1190027F1022", "approvalTimeline": [ { "date": "2019-12", "title": { "zh": "美国 NDA 212028 初始批准", "en": "Initial U.S. NDA 212028 approval" }, "detail": { "zh": "FDA 批准记录把 DAYVIGO、莱博雷生和 Eisai 相连；批准不等于任何地点的实时库存或个人适用性。", "en": "The FDA approval record links DAYVIGO, lemborexant and Eisai. Approval does not establish real-time local stock or individual suitability." }, "source": { "id": "src_b349d6bcc5f44eb8", "label": "FDA：DAYVIGO（lemborexant）NDA 212028 初始批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212028Orig1s000Approv.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_decision", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2020", "title": { "zh": "日本 デエビゴ 产品批准", "en": "Japanese DAYVIGO product approvals" }, "detail": { "zh": "PMDA 当前记录列 2.5、5、10 mg 三个产品；日本强度和文字不能自动套用到美国或其他市场。", "en": "Current PMDA records list 2.5, 5 and 10 mg products. Japanese strengths and wording do not automatically transfer to the United States or another market." }, "source": { "id": "src_d6917cceba82f5d2", "label": "日本 PMDA：デエビゴ（莱博雷生）2.5/5/10 mg 当前专业产品记录、电子说明书与患者资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190027F1022_1?user=1", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2025-02", "title": { "zh": "美国 DailyMed SPL v39 更新", "en": "U.S. DailyMed SPL v39 update" }, "detail": { "zh": "当前公开标签展示四个准确瓶装面板、Medication Guide 与安全文字。", "en": "The current public label displays four exact bottle panels, a Medication Guide and safety wording." }, "source": { "id": "src_02bc131fe45183ab", "label": "DailyMed（NLM）：DAYVIGO 莱博雷生口服片当前美国公开标签、Medication Guide 与四个瓶装包装面板（SPL v39；2025-02 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前品牌标签与四个准确瓶装已链接", "en": "Current brand label and four exact bottles linked" }, "detail": { "zh": "本页列 5/10 mg 的 30/90 片瓶装；不证明药店库存、购买资格或个人适用性。", "en": "The page lists 5/10 mg in 30/90-tablet bottles; it does not establish pharmacy stock, purchase eligibility or individual suitability." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "当前 2.5/5/10 mg 产品、电子说明书与患者指南已链接；暂无准确包装图", "en": "Current 2.5/5/10 mg products, electronic label and patient guide linked; no exact package image established" }, "detail": { "zh": "三张日本身份卡只用 PMDA 文字，不借用美国包装图。", "en": "The three Japanese identity cards use PMDA text only and do not borrow U.S. pack images." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国或日本品牌、颜色、刻字或毫克数推定当地批准、供应、原研/仿制关系或可替代性。", "en": "No local approval, supply, originator/generic relationship or interchangeability is inferred from a U.S. or Japanese brand, colour, imprint or milligram number." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "DAYVIGO 与 BELSOMRA 是同一种药吗？", "en": "Are DAYVIGO and BELSOMRA the same medicine?" }, "answer": { "zh": "不是。DAYVIGO 含莱博雷生，BELSOMRA 含苏沃雷生。共同作用于食欲素受体不表示可以按 mg 自行替换、叠加或轮换。", "en": "No. DAYVIGO contains lemborexant and BELSOMRA contains suvorexant. Shared orexin-receptor activity does not permit self-substitution, combination or rotation by milligrams." } }, { "question": { "zh": "老人早晨很困或跌倒，还能自己减半吗？", "en": "Can an older adult halve the tablet after morning drowsiness or a fall?" }, "answer": { "zh": "不要凭网页自行掰片、减量或停药。先避免驾驶和危险活动，记录实际药盒、发生时间、酒精及所有同服药，及时联系开方团队或药师；意识异常、严重受伤或呼吸困难应使用当地急救。", "en": "Do not self-split, reduce or stop from this page. Avoid driving and hazardous activity, record the actual pack, timing, alcohol and every co-medication, and contact the prescriber or pharmacist promptly. Altered awareness, serious injury or breathing difficulty requires local emergency help." } }, { "question": { "zh": "美国和日本都有 5 mg、10 mg，可以直接互换吗？", "en": "Can U.S. and Japanese 5 mg or 10 mg products be directly interchanged?" }, "answer": { "zh": "不能只凭共同毫克数判断。市场批准、处方、包装、辅料、供药体系和现行说明书都要分别核对；本页日本身份卡没有包装图，不能拿美国图片做真伪判断。", "en": "Not from a shared milligram figure. Market approval, prescription, pack, excipients, supply system and current label all require separate review. The Japanese identity cards have no package image here, so a U.S. image cannot authenticate them." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dayvigo-lemborexant/", "en": "https://origindrug.com/en/drugs/dayvigo-lemborexant/" }, "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." ] }