{ "id": "lunesta-eszopiclone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-09-02", "status": "published_traceable_archive" }, "names": { "brand": "LUNESTA", "generic": "右佐匹克隆薄膜衣片", "aliases": [ "Lunesta", "eszopiclone", "右佐匹克隆", "右佐匹克隆片", "艾司佐匹克隆", "eszopiclone tablets", "LUNESTA", "NDA 021476", "80725-010-30", "80725-011-30", "80725-012-30", "S190", "S191", "S193" ], "marketBrandNames": [ { "name": "LUNESTA", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "NDA 021476；当前标签列 1、2、3 mg 三个 30 片瓶装。监管标签不等于实时供应或个人适用。", "en": "NDA 021476; the current label lists three 30-tablet bottles at 1, 2 and 3 mg. A regulatory label is not live supply or individual suitability." }, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 当前 LUNESTA 品牌标签列 1、2、3 mg 三种薄膜衣片，均为 30 片瓶装并归入 NDA 021476。页面记录美国 C-IV 管制药品身份；不把该分类外推为其他市场法律状态、实时库存或个人适用性。", "dosageFormClass": "右佐匹克隆普通薄膜衣口服片。LUNESTA、AMBIEN（唑吡坦）、DAYVIGO（莱博雷生）、BELSOMRA（苏沃雷生）及佐匹克隆不是同一种药，不建立 mg 换算、轮换、叠加或停换规则。", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2004（美国初始批准年份）", "archiveSponsorText": "Waylis Therapeutics LLC（当前美国品牌标签包装方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "LUNESTA eszopiclone", "eszopiclone tablets", "右佐匹克隆片" ], "excludedProductCues": [ "zopiclone", "佐匹克隆", "zolpidem", "唑吡坦", "AMBIEN", "DAYVIGO", "BELSOMRA", "suvorexant", "lemborexant" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lunesta-eszopiclone-1mg-30-tablet-bottle-ndc-8072501030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-07 修订）", "en": "Current U.S. DailyMed brand label (revised Jul 2023)" }, "dosageForm": { "zh": "LUNESTA 右佐匹克隆薄膜衣口服片", "en": "LUNESTA eszopiclone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-010-30", "pouchCode": null, "applicationNumber": "NDA 021476", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片右佐匹克隆 1 mg；30 片瓶装", "en": "Eszopiclone 1 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-03.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "右佐匹克隆", "en": "eszopiclone" }, "value": 1, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠时长、加量或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "浅蓝色", "en": "light blue" }, "shape": { "zh": "圆形薄膜衣片；当前标签未列刻痕", "en": "round film-coated tablet; current label does not list a score" }, "imprint": "S190", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lunesta-eszopiclone-2mg-30-tablet-bottle-ndc-8072501130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-07 修订）", "en": "Current U.S. DailyMed brand label (revised Jul 2023)" }, "dosageForm": { "zh": "LUNESTA 右佐匹克隆薄膜衣口服片", "en": "LUNESTA eszopiclone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-011-30", "pouchCode": null, "applicationNumber": "NDA 021476", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片右佐匹克隆 2 mg；30 片瓶装", "en": "Eszopiclone 2 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-04.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "右佐匹克隆", "en": "eszopiclone" }, "value": 2, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠时长、加量或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片；当前标签未列刻痕", "en": "round film-coated tablet; current label does not list a score" }, "imprint": "S191", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lunesta-eszopiclone-3mg-30-tablet-bottle-ndc-8072501230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国品牌标签（2023-07 修订）", "en": "Current U.S. DailyMed brand label (revised Jul 2023)" }, "dosageForm": { "zh": "LUNESTA 右佐匹克隆薄膜衣口服片", "en": "LUNESTA eszopiclone film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 80725-012-30", "pouchCode": null, "applicationNumber": "NDA 021476", "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片右佐匹克隆 3 mg；30 片瓶装", "en": "Eszopiclone 3 mg per tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-05.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "右佐匹克隆", "en": "eszopiclone" }, "value": 3, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠时长、加量或补服指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep duration, increase or make-up instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "current_regulatory_listing_not_live_stock", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "深蓝色", "en": "dark blue" }, "shape": { "zh": "圆形薄膜衣片；当前标签未列刻痕", "en": "round film-coated tablet; current label does not list a score" }, "imprint": "S193", "scoreStatus": "unscored_no_split_permission_inferred", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-lunesta-eszopiclone-1mg-30-tablet-bottle-ndc-8072501030", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lun01-0029-03.jpg&setid=3821f4b7-a3c8-4920-ba80-18aa96532c09&type=img", "alt": "LUNESTA 右佐匹克隆 1 mg、NDC 80725-010-30、30 片瓶装的 DailyMed 官方标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前美国品牌标签（2023-07 修订）", "presentation": "1 mg：浅蓝色圆片、S190；NDC 80725-010-30，30 片瓶装。另有 2 mg 白色 S191 与 3 mg 深蓝色 S193 准确包装，须按 NDC 分开核对。", "notice": "此图只对应美国 NDC 80725-010-30 的 1 mg、30 片瓶装，不代表其他强度、佐匹克隆、唑吡坦、其他安眠药、其他市场包装或实时库存，也不用于鉴定真伪。", "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LUNESTA 说明书放大阅读：每片 mg、复杂睡眠行为、次日警觉与镇静叠加", "en": "LUNESTA enlarged label: mg per tablet, complex sleep behaviours, next-day alertness and additive sedation" }, "summary": { "zh": "1、2、3 mg 是每片右佐匹克隆含量；30 Tablets 是整瓶片数。标签有复杂睡眠行为黑框警示。网页只把准确药盒和安全问题讲清楚，不根据失眠天数或昨晚睡眠自行生成片数、服用时点、补服、递减或停换方案。", "en": "The 1, 2 and 3 mg figures are eszopiclone per tablet; 30 Tablets is the bottle count. The label has a boxed warning for complex sleep behaviours. The site explains the exact pack and safety questions but generates no tablet count, timing, make-up, taper or switch from nights of insomnia or last night's sleep." }, "checks": [ { "zh": "梦游、睡眠驾驶、做饭、打电话或在未完全清醒时进行其他活动，即使以前没有发生、即使同时没有饮酒，也可能在首次或以后使用时出现并造成严重伤害。出现后不要自行再次尝试，应立即联系开方团队；急性危险使用当地急救。", "en": "Sleep-walking, sleep-driving, preparing food, making calls or another activity while not fully awake can occur on the first or a later use, even without prior history or alcohol, and can cause serious injury. Do not self-rechallenge; contact the prescriber promptly, and use local emergency care for immediate danger." }, { "zh": "次日嗜睡、反应变慢、记忆或协调受影响会增加驾驶、操作设备和跌倒风险；老人、夜间起床者或计划早起驾驶者应特别把完整情况交给开方团队核对。网页不以‘感觉清醒’证明安全。", "en": "Next-day sleepiness and impaired reaction, memory or coordination can affect driving, equipment use and fall risk. Older adults, people who rise at night or plan early driving need review of the full situation. Feeling awake is not proof of safety." }, { "zh": "酒精、阿片类止痛药、苯二氮䓬类抗焦虑药、其他安眠药、镇静抗组胺药或其他中枢抑制药可能叠加镇静、呼吸和协调风险；不要自行错开、轮换或叠加。", "en": "Alcohol, opioids, benzodiazepine anxiolytics, another sleep medicine, a sedating antihistamine or another CNS depressant can add sedation, breathing and coordination risk. Do not self-space, rotate or combine them." }, { "zh": "标签还涉及至少保留足够睡眠时间、重餐后吸收变慢、强 CYP3A4 抑制剂、肝功能、呼吸功能、抑郁/自杀风险、停用反应和口中异味。任何变化应由开方团队结合准确药盒和完整药单判断。", "en": "The label also addresses adequate time for sleep, slower absorption after a heavy meal, strong CYP3A4 inhibitors, liver and respiratory function, depression/suicidality, withdrawal effects and unpleasant taste. The prescriber should assess any change using the exact pack and complete medicine list." } ], "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "右佐匹克隆怎样促进入睡：影响 GABA 受体复合体，不等于可以与其他镇静药相加", "en": "How eszopiclone promotes sleep: action at the GABA receptor complex does not permit addition to other sedatives" }, "summary": { "zh": "标签说明精确机制尚不完全明确，其作用被认为与 GABA 受体复合体、靠近或变构偶联于苯二氮䓬受体的结合位点相互作用有关。‘非苯二氮䓬’不表示没有镇静、行为、依赖、撤药或次日影响；机制不能替个人选药。", "en": "The label states that the precise mechanism is unknown; effects are believed to involve interaction with the GABA receptor complex at binding domains close to or allosterically coupled to benzodiazepine receptors. ‘Nonbenzodiazepine’ does not mean no sedation, behavioural, dependence, withdrawal or next-day effect, and mechanism cannot select a medicine for an individual." }, "checks": [ { "zh": "LUNESTA、AMBIEN、佐匹克隆、DAYVIGO、BELSOMRA、苯二氮䓬类和镇静抗组胺药不是同一种药；共同用于睡眠不建立 mg 换算或轮换表。", "en": "LUNESTA, AMBIEN, zopiclone, DAYVIGO, BELSOMRA, benzodiazepines and sedating antihistamines are not one medicine. A shared sleep-related use creates no milligram conversion or rotation table." }, { "zh": "老人一堆药时，应把非处方感冒/过敏药、止痛药、抗焦虑药、抗抑郁药、酒精及保健品一起列出；品牌不同不排除镇静作用叠加。", "en": "For an older adult with many medicines, include OTC cold/allergy products, pain medicines, anxiolytics, antidepressants, alcohol and supplements. Different brands do not exclude additive sedation." }, { "zh": "失眠可能与疼痛、呼吸、抑郁焦虑、昼夜节律、药物或其他疾病有关；网页不能由作用机制判断该加药、换药、停药或做基因筛查。", "en": "Insomnia may relate to pain, breathing, depression/anxiety, circadian rhythm, medicines or another condition. A mechanism cannot tell the site to add, switch, stop a medicine or order genetic screening." } ], "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "LUNESTA", "generic": "右佐匹克隆薄膜衣片", "dosageFormClass": "右佐匹克隆普通薄膜衣口服片。LUNESTA、AMBIEN（唑吡坦）、DAYVIGO（莱博雷生）、BELSOMRA（苏沃雷生）及佐匹克隆不是同一种药，不建立 mg 换算、轮换、叠加或停换规则。" }, "labelSource": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "productRoutes": [ { "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "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": "2026-09-02", "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": "2026-09-02", "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": "LUNESTA 是右佐匹克隆薄膜衣片品牌档案。1/2/3 mg 是每片含量，30 Tablets 是整瓶片数。老人、多药使用者或次日需驾驶者应优先核对梦游/睡眠驾驶、次日警觉下降、跌倒、酒精、阿片、抗焦虑药、其他安眠镇静药与强 CYP3A4 抑制剂；网页不替个人决定片数、时间、停药、加量或换药。", "history": "FDA 于 2004-12-15 批准 LUNESTA NDA 021476。2019 年补充批准把可能造成严重伤害或死亡的复杂睡眠行为加入黑框警示。当前 DailyMed 标签由 Waylis Therapeutics LLC 包装，公开三个 30 片瓶装面板。", "sourceDocuments": [ { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_816ce49cce92b200", "label": "FDA：LUNESTA NDA 021476/S-038 复杂睡眠行为黑框警示补充批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s038ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, { "id": "src_fba7ddd8fdd479dc", "label": "FDA：LUNESTA NDA 021476 原始批准资料（2004-12-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta_approv.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_package", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 021476", "approvalTimeline": [ { "date": "2004-12-15", "title": { "zh": "LUNESTA 美国原始批准", "en": "Original U.S. approval of LUNESTA" }, "detail": { "zh": "FDA 原始批准资料列 1、2、3 mg 右佐匹克隆片及失眠适应证。", "en": "The FDA original approval package lists 1, 2 and 3 mg eszopiclone tablets for insomnia." }, "source": { "id": "src_fba7ddd8fdd479dc", "label": "FDA：LUNESTA NDA 021476 原始批准资料（2004-12-15）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021476_Lunesta_approv.PDF", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_package", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2019-08-18", "title": { "zh": "FDA 批准复杂睡眠行为黑框警示", "en": "FDA approved the boxed warning for complex sleep behaviours" }, "detail": { "zh": "NDA 021476/S-038 针对非快速眼动睡眠异态行为更新标签，并记录严重伤害风险。", "en": "NDA 021476/S-038 updated the label for NREM parasomnias and recorded the risk of serious injury." }, "source": { "id": "src_816ce49cce92b200", "label": "FDA：LUNESTA NDA 021476/S-038 复杂睡眠行为黑框警示补充批准函（2019）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021476Orig1s038ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_regulatory_document", "documentKind": "regulatory_approval_letter", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } }, { "date": "2023-07-15", "title": { "zh": "当前 DailyMed 品牌标签修订", "en": "Current DailyMed brand-label revision" }, "detail": { "zh": "当前说明书、Medication Guide 与三个 Waylis 30 片瓶装面板可公开阅读。", "en": "The current label, Medication Guide and three Waylis 30-tablet bottle panels are publicly readable." }, "source": { "id": "src_662b67a3310fb05f", "label": "DailyMed（NLM）：LUNESTA 右佐匹克隆当前美国品牌标签、Medication Guide 及三个 30 片瓶装面板", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3821f4b7-a3c8-4920-ba80-18aa96532c09", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前公开品牌标签", "en": "Current public brand label" }, "detail": { "zh": "NDA 021476；1、2、3 mg，三个 30 片瓶装；美国 C-IV。", "en": "NDA 021476; 1, 2 and 3 mg in three 30-tablet bottles; U.S. C-IV." } }, { "market": { "zh": "美国以外市场", "en": "Markets outside the United States" }, "status": { "zh": "本档案未确认当地商品名、法律分类、包装或供应", "en": "Local brand, legal classification, pack and supply are not established" }, "detail": { "zh": "右佐匹克隆、艾司佐匹克隆与佐匹克隆等名称须与当地监管记录和手中药盒逐项核对。", "en": "Names such as eszopiclone and zopiclone require item-by-item checking against the local regulator and pack in hand." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "LUNESTA 和佐匹克隆、唑吡坦、DAYVIGO 是一回事吗？", "en": "Are LUNESTA, zopiclone, zolpidem and DAYVIGO the same medicine?" }, "answer": { "zh": "不是。它们成分、产品、机制细节、市场记录和说明书边界不同；不能按商品名、颜色、用途或 mg 自行换算、轮换或叠加。", "en": "No. Their ingredients, products, mechanism details, market records and label boundaries differ. Brand, colour, purpose or milligrams do not permit self-conversion, rotation or combination." } }, { "question": { "zh": "昨晚没睡好，今晚能自行多吃或再加一种安眠药吗？", "en": "Can I take more or add another sleep medicine after a poor night?" }, "answer": { "zh": "网页不能这样决定。加量或叠加可能增加复杂睡眠行为、次日损害、跌倒和呼吸风险；请用准确药盒、处方、睡眠时间、酒精及完整药单让开方团队或药师核对。", "en": "The site cannot make that decision. Increasing or combining can increase complex sleep behaviour, next-day impairment, falls and breathing risk. Have the prescriber or pharmacist review the exact pack, prescription, available sleep time, alcohol and complete medicine list." } }, { "question": { "zh": "药片很小，可以掰半或与其他强度拼吗？", "en": "The tablet is small. Can it be split or assembled with another strength?" }, "answer": { "zh": "不要从外观或总毫克数推断。当前标签未把刻痕或分片写成个人调整许可；改变规格、片数或停用方式前应让开方团队核对准确处方。", "en": "Do not infer from appearance or total milligrams. The current label does not turn a score or splitting into permission for individual adjustment. Review the exact prescription before changing strength, tablet count or stopping." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-unit-literacy", "same-class-is-not-same-medicine", "interactions-are-not-a-home-scheduling-problem" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/lunesta-eszopiclone/", "en": "https://origindrug.com/en/drugs/lunesta-eszopiclone/" }, "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." ] }