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verified 30 Aug 2026)" }, "dosageForm": { "zh": "ベルソムラ 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant 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 22800AMX00671000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 10 mg；日本 PMDA 产品身份", "en": "Suvorexant 10 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生（スボレキサント）", "en": "suvorexant" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、年龄对应用法或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "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": "极浅绿色", "en": "very pale green" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "33", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_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-belsomra-suvorexant-15mg-tablet-22600amx01302000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2026-03 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)" }, "dosageForm": { "zh": "ベルソムラ 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant 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 22600AMX01302000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 15 mg；日本 PMDA 产品身份", "en": "Suvorexant 15 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生（スボレキサント）", "en": "suvorexant" }, "value": 15, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、年龄对应用法或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "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": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片", "en": "oval film-coated tablet" }, "imprint": "325", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_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-belsomra-suvorexant-20mg-tablet-22600amx01303000", "marketCode": "JP", "labelVersion": { "zh": "PMDA 当前日本电子说明书（2026-03 修订；2026-08-30 核验）", "en": "Current Japanese PMDA electronic label (revised Mar 2026; verified 30 Aug 2026)" }, "dosageForm": { "zh": "ベルソムラ 苏沃雷生口服薄膜衣片", "en": "BELSOMRA suvorexant 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 22600AMX01303000", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片苏沃雷生 20 mg；日本 PMDA 产品身份", "en": "Suvorexant 20 mg per tablet; Japanese PMDA product identity" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "苏沃雷生（スボレキサント）", "en": "suvorexant" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片日本标签标示量；不是个人片数、频率、年龄对应用法或跨市场换算", "en": "Japanese labelled amount per tablet; not an individual's tablet count, frequency, age-based regimen or cross-market conversion" } } ], "concentration": null, "container": { "typeCode": "not_established", "typeLabel": { "zh": "包装数量未在本身份卡中建立", "en": "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": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "335", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_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-belsomra-suvorexant-10mg-30-blister-carton-ndc-0006003330", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=belsomra-05.jpg&setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "alt": "BELSOMRA 苏沃雷生 10 mg、NDC 0006-0033-30、30 片泡罩纸盒在美国 DailyMed 当前标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v21（2025-03-10 更新）", "presentation": "BELSOMRA 10 mg、NDC 0006-0033-30、30 片泡罩纸盒标签展示面", "notice": "此图只对应美国当前标签中的 BELSOMRA 10 mg、NDC 0006-0033-30、30 片泡罩纸盒。其他强度各有独立包装卡；它不代表日本包装、DAYVIGO、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。", "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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": "BELSOMRA 说明书放大阅读：先核对每片 mg，再看次日清醒、跌倒与合并用药", "en": "BELSOMRA label reading: check mg per tablet, next-day alertness, falls and co-medication" }, "summary": { "zh": "5、10、15、20 mg 是每片苏沃雷生的标签标示量，不是网页给出的个人服用方案。老人或同时使用安眠药、镇静药、阿片类、酒精及 CYP3A 相关药物者，更需要把完整药单和实际药盒交给专业人员核对。", "en": "The 5, 10, 15 and 20 mg figures are labelled suvorexant amounts per tablet, not a personal regimen supplied by this site. Older adults and people also using sleep medicines, sedatives, opioids, alcohol or CYP3A-related medicines particularly need professional review of the full medicine list and actual pack." }, "checks": [ { "zh": "不要把包装上的 mg 当成‘应该吃几颗’。美国和日本产品强度及标签用法文字不同；年龄、药物相互作用和所在市场都不能由网页换算成个人片数、时间或补服方案。", "en": "Do not read the pack mg as a tablet count. U.S. and Japanese strengths and label instructions differ; age, interactions and market cannot be converted by this site into an individual tablet count, timing or make-up plan." }, { "zh": "苏沃雷生可能影响次日清醒、注意力和运动协调。早晨仍困倦、反应变慢、步态不稳或老人跌倒时，不要自行驾车、操作危险设备、追加另一种安眠药或用酒精‘帮助睡眠’，应及时联系专业人员核对。", "en": "Suvorexant can affect next-day alertness, attention and motor coordination. If morning drowsiness, slowed reactions, unsteady gait or a fall occurs, do not drive, operate hazardous equipment, add another sleep medicine or use alcohol to ‘help sleep’; seek timely professional review." }, { "zh": "梦游、睡眠驾驶、在未完全清醒时进食、打电话或进行其他活动属于复杂睡眠行为警讯。若发生，应确保安全并立即联系开方团队；受伤、意识异常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 warning signs. If this occurs, secure immediate safety and contact the prescriber; injury, altered awareness or another acute danger requires local emergency support." }, { "zh": "酒精、阿片类、苯二氮䓬类、其他安眠镇静药、部分抗过敏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。不要按‘都是晚上吃’自行叠加、轮换或共享。", "en": "Alcohol, opioids, benzodiazepines, other sleep/sedative medicines, some allergy medicines and other CNS depressants can add drowsiness, slowed reactions, breathing or fall risk. Do not combine, rotate or share them merely because they are all used at night." }, { "zh": "强或中度 CYP3A 抑制剂及诱导剂会影响专业用药安排；日本现行说明书还列出若干不能合并使用的药物。带上抗感染药、心血管药、抗真菌药、抗病毒药、保健品和完整药单核对，不能只凭一个药名决定同服。", "en": "Strong or moderate CYP3A inhibitors and inducers can affect professional management, and the current Japanese label lists several medicines that must not be combined. Bring anti-infectives, cardiovascular medicines, antifungals, antivirals, supplements and the full list for review rather than deciding from one name." }, { "zh": "发作性睡病是美国标签禁忌；呼吸功能受损、抑郁或自伤想法变化、睡眠瘫痪、幻觉样体验和猝倒样症状也需要专业评估。网页不会用睡眠时长、年龄或症状自行诊断或选药。", "en": "Narcolepsy is a U.S. label contraindication. Compromised respiratory function, worsening depression or self-harm thoughts, sleep paralysis, hallucination-like experiences and cataplexy-like symptoms also need professional assessment. The site does not diagnose or select treatment from sleep duration, age or symptoms." } ], "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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": "苏沃雷生怎样作用：阻断 OX1R 与 OX2R 食欲素受体，减弱促清醒信号", "en": "How suvorexant works: blocking OX1R and OX2R orexin receptors to reduce wake signalling" }, "summary": { "zh": "苏沃雷生是双食欲素受体拮抗剂，可结合 OX1R 和 OX2R，抑制食欲素系统的促清醒作用。通俗地说，它不是把所有神经活动‘关掉’，而是减弱一种维持清醒的信号；这个机制不能预测某个人是否适合、该选多少 mg，或能否与其他安眠镇静药叠加。", "en": "Suvorexant is a dual orexin-receptor antagonist that binds OX1R and OX2R and suppresses wake-promoting orexin signalling. In plain language, it does not ‘switch off’ all brain activity; it reduces one wake-maintaining signal. This mechanism cannot predict individual suitability, strength choice or safe combination with another sleep or sedative medicine." }, "checks": [ { "zh": "与唑吡坦、苯二氮䓬类或其他睡眠药作用机制不同，不表示它更适合每个人，也不表示可以按 mg 对换、隔天轮换或叠加。", "en": "A different mechanism from zolpidem, benzodiazepines or other sleep medicines does not make it better for everyone or permit milligram substitution, alternate-day rotation or combination." }, { "zh": "原研与仿制产品可以共享活性成分和监管等效性依据，但外观、辅料与包装未必相同；替代必须查目标市场现行批准和个人处方，不能从颜色、共同机制或商品名自行决定。", "en": "Originator and generic products can share an active ingredient and regulatory equivalence basis while appearance, excipients and packaging may differ. Substitution requires the current target-market approval and individual prescription, not colour, a shared mechanism or brand name." }, { "zh": "食欲素系统参与维持清醒，但‘阻断促清醒信号’不等于可以从失眠表现推断病因，也不能据此忽略次日困倦、跌倒、呼吸、情绪或复杂睡眠行为等完整标签警示。", "en": "Orexin signalling helps maintain wakefulness, but ‘blocking a wake signal’ cannot establish the cause of insomnia or displace the full label warnings about next-day impairment, falls, breathing, mood or complex sleep behaviours." } ], "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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": "BELSOMRA", "generic": "苏沃雷生", "dosageFormClass": "口服薄膜衣片；美国 5、10、15、20 mg，30 片单位使用泡罩纸盒，C-IV 管制药物；日本 10、15、20 mg 产品。市场说明、包装与监管分类必须分别阅读" }, "labelSource": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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_b0e3acba0771e25e", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 当前电子说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170050_1190023F1024_1_19", "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": "BELSOMRA 是苏沃雷生口服片的美国品牌，日本使用ベルソムラ。美国当前标签展示 5、10、15、20 mg 四个 30 片泡罩纸盒。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 相互作用和呼吸风险；不生成个人片数、服用时间、补服、停药或换药方案。", "history": "FDA 于 2014-08-13 批准 NDA 204569。美国当前标签将 BELSOMRA 列为 C-IV 管制药物；日本 PMDA 当前记录列 10、15、20 mg 产品并提供专业说明书和患者指南。批准史、强度差异及各市场用法文字只用于来源核对，不能拿来跨市场自行选择强度或换算片数。", "sourceDocuments": [ { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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_96ab5a582f5e5224", "label": "FDA Drugs@FDA：BELSOMRA（suvorexant）NDA 204569 申请与标签记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204569", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_database_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_9fd7fa645d512018", "label": "FDA：BELSOMRA（suvorexant）NDA 204569 初始批准函（2014-08-13）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.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_d306e20472ccaba8", "label": "FDA：BELSOMRA 苏沃雷生 NDA 204569 跨学科审评资料（5/10/15/20 mg）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/204569Orig1s000CrossR.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_f9a83bed7d1cd309", "label": "FDA：BELSOMRA NDA 204569/S-010 补充批准函与哺乳期标签更新（2025）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204569Orig1s010ltr.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_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_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_6e521835a493de99", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 公众用药品信息入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_1?user=2", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "consumer_medicine_information", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_b0e3acba0771e25e", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 当前电子说明书（2026-03 修订）", "url": "https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/170050_1190023F1024_1_19", "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_a6b9b23fa67ca053", "label": "日本 PMDA：ベルソムラ 10/15/20 mg 患者向医药品指南", "url": "https://www.info.pmda.go.jp/downfiles/guide/ph/170050_1190023F1024_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" } ], "applicationNumber": "FDA NDA 204569（BELSOMRA / suvorexant tablets）；日本 PMDA 1190023F1024", "approvalTimeline": [ { "date": "2014-08-13", "title": { "zh": "美国 NDA 204569 初始批准", "en": "Initial U.S. NDA 204569 approval" }, "detail": { "zh": "FDA 批准 BELSOMRA 苏沃雷生 5、10、15、20 mg 口服片；批准史不等于任何地点当前库存或个人适用性。", "en": "FDA approved BELSOMRA suvorexant 5, 10, 15 and 20 mg oral tablets. Approval history does not establish current local stock or individual suitability." }, "source": { "id": "src_9fd7fa645d512018", "label": "FDA：BELSOMRA（suvorexant）NDA 204569 初始批准函（2014-08-13）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204569Orig1s000rltr.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": "2014-11-01", "title": { "zh": "日本 15 mg 与 20 mg 产品开始销售", "en": "Japanese 15 mg and 20 mg products launched" }, "detail": { "zh": "PMDA 当前说明书记录日本 15 mg、20 mg 产品的批准及销售节点；本页不由此生成任何年龄对应片数。", "en": "The current PMDA label records approval and launch milestones for the Japanese 15 mg and 20 mg products; this page does not turn them into an age-based tablet count." }, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_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": "2016-12-01", "title": { "zh": "日本 10 mg 产品开始销售", "en": "Japanese 10 mg product launched" }, "detail": { "zh": "PMDA 当前说明书记录 10 mg 产品后续加入；市场强度差异不是跨市场自行换算依据。", "en": "The current PMDA label records the later 10 mg product; market strength differences are not a basis for self-conversion." }, "source": { "id": "src_6b52137ca193d9e0", "label": "日本 PMDA：ベルソムラ（苏沃雷生）10/15/20 mg 当前专业产品记录、电子说明书、患者指南与安全资料入口", "url": "https://www.pmda.go.jp/PmdaSearch/rdDetail/iyaku/1190023F1024_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": "2025-03-10", "title": { "zh": "当前美国 DailyMed 标签更新", "en": "Current U.S. DailyMed label updated" }, "detail": { "zh": "SPL v21 展示四个 30 片泡罩纸盒和 Medication Guide，并保留 C-IV、次日影响与复杂睡眠行为等安全边界。", "en": "SPL v21 displays four 30-tablet blister cartons and a Medication Guide, retaining C-IV, next-day impairment and complex-sleep-behaviour boundaries." }, "source": { "id": "src_58d585214668a64d", "label": "DailyMed（NLM）：BELSOMRA 苏沃雷生口服片当前美国公开标签、Medication Guide 与四个 30 片泡罩纸盒面板（SPL v21；2025-03-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951", "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 BELSOMRA 品牌标签、Medication Guide、NDA 和四个准确泡罩纸盒已链接", "en": "Current BELSOMRA brand label, Medication Guide, NDA and four exact blister cartons linked" }, "detail": { "zh": "页面展示四个 30 片纸盒的官方标签面板；标签存在不证明本地库存、保险覆盖、可购买资格或个人适用性。", "en": "The page displays official label panels for four 30-tablet cartons. Label presence does not establish local stock, insurance coverage, purchase eligibility or individual suitability." } }, { "market": { "zh": "日本", "en": "Japan" }, "status": { "zh": "当前 ベルソムラ 10/15/20 mg 产品记录、电子说明书和患者指南已链接", "en": "Current BELSOMRA 10/15/20 mg product records, electronic label and patient guide linked" }, "detail": { "zh": "本轮保留 PMDA 产品身份和片剂外观文字，但未取得可与单一日本包装逐一对应的官方主展示面，因此不以美国药盒或零售图代替。", "en": "This review retains PMDA product identities and tablet-appearance text but did not obtain an official principal display panel matched one-to-one to a Japanese pack, so no U.S. carton or retail image is substituted." } }, { "market": { "zh": "中国大陆、欧盟及其他市场", "en": "Mainland China, European Union and other markets" }, "status": { "zh": "待逐项建立现行监管记录", "en": "Current regulatory records not yet established" }, "detail": { "zh": "不从美国或日本记录推定当地批准、供应、包装、处方资格或原研/仿制关系。", "en": "No local approval, supply, pack, prescription eligibility or originator/generic relationship is inferred from U.S. or Japanese records." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "BELSOMRA 是不是普通安眠药？", "en": "Is BELSOMRA just another ordinary sleeping pill?" }, "answer": { "zh": "它是双食欲素受体拮抗剂，作用机制和部分其他睡眠药不同，但仍可能造成次日困倦、复杂睡眠行为、跌倒和药物相互作用。不同机制不表示更安全或适合每个人。", "en": "It is a dual orexin-receptor antagonist with a different mechanism from some other sleep medicines, but it can still cause next-day drowsiness, complex sleep behaviours, falls and interactions. A different mechanism does not mean safer or suitable for everyone." } }, { "question": { "zh": "老人看到 10、15、20 mg，应该自己选哪一盒？", "en": "Which 10, 15 or 20 mg pack should an older adult choose?" }, "answer": { "zh": "不能从年龄或包装数字自行选择。不同市场标签、完整药单、肝功能、呼吸情况、跌倒风险和其他药物都可能影响专业决策；请把实际药盒与全部用药交给开方团队核对。", "en": "Do not choose from age or pack numbers. Market label, full medicine list, liver function, breathing status, fall risk and other medicines can affect professional decisions; have the prescriber review the actual pack and all medicines." } }, { "question": { "zh": "睡不着时能再加半片或和另一种安眠药一起吃吗？", "en": "Can I add half a tablet or another sleep medicine when I cannot sleep?" }, "answer": { "zh": "不要自行加片、掰片、补服或叠加。刻痕和包装 mg 不是加减量许可；额外中枢抑制可能增加次日影响、跌倒、复杂睡眠行为或呼吸风险。", "en": "Do not self-add, split, make up or combine tablets. A score or pack mg is not permission to change use; added CNS depression may increase next-day impairment, falls, complex sleep behaviours or breathing risk." } }, { "question": { "zh": "可以用酒精帮助药效吗？", "en": "Can alcohol help the medicine work?" }, "answer": { "zh": "不应把酒精当作助眠组合。酒精可能叠加嗜睡、协调受损、记忆问题和跌倒风险；带上真实饮酒情况让专业人员核对。", "en": "Alcohol should not be used as a sleep combination. It can add drowsiness, impaired coordination, memory problems and falls; disclose actual alcohol use for professional review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist", "dosage-forms-are-part-of-medicine-identity", "generic-drugs-and-bioequivalence" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/belsomra-suvorexant/", "en": "https://origindrug.com/en/drugs/belsomra-suvorexant/" }, "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." ] }