{ "id": "desyrel-trazodone", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "DESYREL / trazodone", "generic": "盐酸曲唑酮", "aliases": [ "DESYREL", "Desyrel", "trazodone", "trazodone hydrochloride", "曲唑酮", "盐酸曲唑酮", "盐酸曲唑酮片", "NDA 018207", "70771-1128-1", "70771-1129-1", "70771-1130-1", "70771-1131-1" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DESYREL NDA 018207 历史品牌标签与当前盐酸曲唑酮通用药标签；当前展示 50/100/150/300 mg 四种 100 片瓶装。品牌历史、当前通用药、包装与供应状态必须分开。", "dosageFormClass": "口服片：当前展示每片 50 mg、100 mg、150 mg、300 mg 盐酸曲唑酮；不把普通片与任何缓释产品或其他市场产品合并", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1981（美国初始批准）", "archiveSponsorText": "FDA DESYREL NDA 018207 历史品牌记录；Novel Laboratories, Inc. 当前通用药标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DESYREL", "trazodone", "trazodone hydrochloride", "盐酸曲唑酮", "盐酸曲唑酮片", "trazodone 50 mg", "trazodone 100 mg", "trazodone 150 mg", "trazodone 300 mg" ], "excludedProductCues": [ "Oleptro", "trazodone extended release", "曲唑酮缓释片", "nefazodone", "奈法唑酮" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-trazodone-hydrochloride-50mg-100-bottle-ndc-7077111281", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1128-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 50 mg；100 片瓶装", "en": "50 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-01.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trazodone-hydrochloride-100mg-100-bottle-ndc-7077111291", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1129-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 100 mg；100 片瓶装", "en": "100 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-02.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trazodone-hydrochloride-150mg-100-bottle-ndc-7077111301", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1130-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 150 mg；100 片瓶装", "en": "150 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-03.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 150, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-trazodone-hydrochloride-300mg-100-bottle-ndc-7077111311", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药公开标签（2026-01-23 更新）", "en": "Current U.S. generic DailyMed label (updated 23 Jan 2026)" }, "dosageForm": { "zh": "盐酸曲唑酮口服片", "en": "trazodone hydrochloride oral tablet" }, "route": { "zh": "口服（准确产品身份字段）", "en": "oral (exact-product identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 70771-1131-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片盐酸曲唑酮 300 mg；100 片瓶装", "en": "300 mg trazodone hydrochloride per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-04.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸曲唑酮", "en": "trazodone hydrochloride" }, "value": 300, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、睡眠用途、掰片、加减量、停药或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, sleep use, splitting, dose change, stopping or switching instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": null, "shape": { "zh": "片剂外观与刻痕须回到所引当前标签和实际药盒核对；不从包装正面推定能否掰片", "en": "Check tablet appearance and score against the cited current label and actual pack; do not infer splitting from the front panel" }, "imprint": null, "scoreStatus": "verify_exact_current_label_before_splitting", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-trazodone-hydrochloride-50mg-100-bottle-ndc-7077111281", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=0b9d3b91-26ed-477b-a88e-2d6a76fedabf-01.jpg&setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&type=img", "alt": "盐酸曲唑酮 50 mg、NDC 70771-1128-1、100 片瓶装在美国 DailyMed 当前通用药标签中的展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 当前通用药标签；2026-01-23 更新", "presentation": "盐酸曲唑酮片：每片 50 mg，NDC 70771-1128-1，100 片瓶装。", "notice": "此图只对应所引当前美国通用药标签中的 50 mg、NDC 70771-1128-1、100 片瓶装。它不是 DESYREL 历史品牌包装，不代表其他强度、厂家、市场、库存或原研身份，不用于鉴定真伪，也不生成个人睡眠/抑郁用药方案。", "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "DESYREL／曲唑酮说明书放大阅读：先分历史品牌、当前通用药与睡眠用途误解", "en": "DESYREL / trazodone label reading: separate brand history, current generics and sleep-use assumptions" }, "summary": { "zh": "当前通用药标签把盐酸曲唑酮列为成人重性抑郁障碍用药；网页不会因为它常被讨论为助眠药，就推导任何人的睡眠用途、片数、时间、加减量或停药方案。先核对准确产品、每片 mg、实际处方、完整药单与目标市场标签。", "en": "The current generic label identifies trazodone hydrochloride for major depressive disorder in adults. Common discussion of sleep use does not let this site derive an individual's sleep use, tablet count, timing, dose change or stopping plan. Check the exact product, mg per tablet, actual prescription, full medicine list and target-market label." }, "checks": [ { "zh": "50、100、150、300 mg 是四种当前通用药片剂的每片标示量，不是把数字相加、用多片拼规格或根据睡眠时长自行选片数的计算器。刻痕也必须按准确厂家标签和处方核对，不能看到线就自行掰片。", "en": "50, 100, 150 and 300 mg are labelled amounts per tablet for four current generic products. They are not a calculator for adding numbers, assembling a strength or choosing tablets from sleep duration. A score must be checked against the exact manufacturer label and prescription rather than treated as automatic permission to split." }, { "zh": "嗜睡、头晕、认知或运动反应受影响时不要驾驶或操作危险设备。老人、使用降压药、利尿药、安眠镇静药、酒精或其他中枢抑制物者，应优先核对体位性低血压、晕厥、跌倒、脱水和完整药单。", "en": "Do not drive or operate hazardous machinery when somnolence, dizziness or impaired cognitive/motor performance occurs. Older adults and people using blood-pressure medicines, diuretics, sedatives, alcohol or other CNS depressants need priority review for orthostatic hypotension, syncope, falls, dehydration and the complete medicine list." }, { "zh": "老年人、使用利尿药或容量不足者还需留意低钠。明显乏力、头痛、混乱、步态不稳、跌倒、抽搐或意识变化需要及时医疗评估，不能只归因于年龄或睡不好。", "en": "Older adults, people using diuretics or those who are volume depleted also need review for hyponatraemia. Marked weakness, headache, confusion, unsteady gait, falls, seizures or altered awareness needs timely medical assessment rather than attribution to age or poor sleep alone." }, { "zh": "另一种影响血清素的抗抑郁药、曲马多、锂剂、丁螺环酮、安非他明、色氨酸、圣约翰草、MAOI、利奈唑胺或静脉亚甲蓝同在药单时，应优先核对血清素综合征与禁忌边界；不要自行叠加、错开或轮换。", "en": "Another serotonergic antidepressant, tramadol, lithium, buspirone, amphetamine, tryptophan, St John's wort, an MAOI, linezolid or intravenous methylene blue on the list requires priority review for serotonin syndrome and contraindication boundaries. Do not self-combine, time-separate or alternate them." }, { "zh": "QT 延长或心律问题、低钾/低镁、相关药物，及阿司匹林、NSAID、抗血小板药或抗凝药同在药单时，应优先核对心律与出血风险。晕厥、胸痛、明显心悸、严重出血或其他急性重症应立即使用当地急救渠道。", "en": "QT prolongation or another rhythm condition, low potassium/magnesium, related medicines, or aspirin, NSAIDs, antiplatelets or anticoagulants on the list requires priority review of rhythm and bleeding risk. Fainting, chest pain, marked palpitations, severe bleeding or another acute serious concern requires immediate local emergency care." }, { "zh": "自伤/自杀想法、明显行为改变、严重过敏样反应、持续勃起伴疼痛或其他急性严重问题需要立即使用当地急救或危机支持；不要等待网页，也不要用另一盒药自行抵消。", "en": "Thoughts of self-harm/suicide, marked behavioural change, a severe allergy-like reaction, a persistent painful erection or another acute serious concern requires immediate local emergency or crisis support. Do not wait for a webpage or try to counteract it with another pack." } ], "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "曲唑酮怎样起作用：血清素相关作用不能推导个人助眠或抗抑郁方案", "en": "How trazodone works: serotonergic activity cannot determine an individual's sleep or antidepressant plan" }, "summary": { "zh": "标签把曲唑酮的抗抑郁作用与血清素再摄取及受体作用联系起来，但完整治疗机制并不能替个人判断适用性、睡眠用途、优劣、片数或与其他精神神经药联用。", "en": "The label relates trazodone's antidepressant activity to serotonin reuptake and receptor effects, but the therapeutic mechanism cannot determine individual suitability, sleep use, superiority, tablet count or combination with other neuropsychiatric medicines." }, "checks": [ { "zh": "“会嗜睡”不是“就是安眠药”，也不是自行开始、与 DAYVIGO、BELSOMRA、AMBIEN、苯二氮卓类、抗组胺药或酒精叠加的依据。", "en": "‘May cause drowsiness’ does not mean ‘is automatically a sleeping pill’ and does not justify self-starting or combining with DAYVIGO, BELSOMRA, AMBIEN, benzodiazepines, antihistamines or alcohol." }, { "zh": "共同影响血清素不表示曲唑酮能与 CELEXA、LEXAPRO、ZOLOFT、PROZAC、PAXIL、CYMBALTA、EFFEXOR、TRINTELLIX 等按 mg 换算、轮换或叠加。", "en": "Shared serotonergic activity does not permit milligram conversion, rotation or combination of trazodone with CELEXA, LEXAPRO, ZOLOFT, PROZAC, PAXIL, CYMBALTA, EFFEXOR, TRINTELLIX or another product." }, { "zh": "历史品牌、当前通用药与相同活性成分可以帮助建立监管和包装核对路径，但不能从机制、商品名或药盒图片判断哪一盒更适合某个人、是否能替代或是否应停换。", "en": "Brand history, current generics and a shared active ingredient can establish regulatory and pack-checking routes, but mechanism, trade name or a pack image cannot determine which product suits an individual, whether it is substitutable or whether it should be stopped or switched." } ], "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "DESYREL / trazodone", "generic": "盐酸曲唑酮", "dosageFormClass": "口服片：当前展示每片 50 mg、100 mg、150 mg、300 mg 盐酸曲唑酮；不把普通片与任何缓释产品或其他市场产品合并" }, "labelSource": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "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": "DESYREL 是盐酸曲唑酮 1981 年美国初始批准品牌的历史档案；本页当前可核对的四个准确包装来自 2026 年更新的美国通用药标签。曲唑酮标签适应症是成人重性抑郁障碍，不应因为常被谈及睡眠就把网页变成个人助眠建议。页面优先解释每片 mg、品牌历史与当前通用药、嗜睡/驾驶、体位性低血压与跌倒、低钠、QT、出血、血清素综合征及完整药单核对边界。", "history": "FDA 记录显示 DESYREL NDA 018207 的美国初始批准年份为 1981。2018 年品牌标签仍可作为历史监管文档阅读；2026 年 DailyMed 当前通用药标签提供四个 100 片瓶装展示面。两类资料共同用于讲清产品历史和当前准确包装，但不证明 DESYREL 品牌当前有货或可购买。", "sourceDocuments": [ { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_bf3886fc5e7376a8", "label": "FDA Drugs@FDA：DESYREL／trazodone hydrochloride NDA 018207 申请记录", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=018207", "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" } ], "applicationNumber": "FDA NDA 018207（DESYREL／trazodone hydrochloride）", "approvalTimeline": [ { "date": "1981", "title": { "zh": "DESYREL 美国初始批准", "en": "Initial U.S. DESYREL approval" }, "detail": { "zh": "FDA 标签记录将 DESYREL 的美国初始批准年份列为 1981。该历史节点不证明当前品牌包装、持有人、供应或可购买性。", "en": "FDA labelling lists 1981 as the initial U.S. approval year for DESYREL. This historical point does not establish a current brand pack, holder, supply or purchase availability." }, "source": { "id": "src_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2018", "title": { "zh": "DESYREL 品牌标签档案", "en": "DESYREL brand-label archive" }, "detail": { "zh": "FDA 公开 2018 年 NDA 018207 品牌标签，保留适应症、黑框警示及安全阅读路径；页面将其明确标为历史品牌资料。", "en": "FDA publishes a 2018 NDA 018207 brand label preserving indication, boxed-warning and safety-reading paths. The page explicitly treats it as historical brand material." }, "source": { "id": "src_d6fd87b9f180c6f5", "label": "FDA：DESYREL（trazodone hydrochloride）NDA 018207 品牌标签档案（2018）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/018207s033lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-01-23", "title": { "zh": "当前通用药标签更新", "en": "Current generic label updated" }, "detail": { "zh": "DailyMed 当前标签展示 50、100、150、300 mg 四个 100 片瓶装面板。标签存在不证明当地库存、可购买性或个人适用性。", "en": "The current DailyMed label displays 50, 100, 150 and 300 mg 100-tablet bottle panels. A label does not establish local stock, purchase availability or individual suitability." }, "source": { "id": "src_c27a916390cb224f", "label": "DailyMed（NLM）：盐酸曲唑酮片当前美国通用药公开标签、Medication Guide 与准确包装面板（2026-01-23 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=43d4be17-5fae-4326-a5c4-9e25e2db6a43&version=8", "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": "已链接 DESYREL 历史品牌标签、NDA 记录与当前通用药准确包装", "en": "Historical DESYREL brand label, NDA record and current exact generic packs linked" }, "detail": { "zh": "历史品牌与当前通用药分开呈现，不把通用药包装冒充 DESYREL，也不把历史标签写成实时供应。", "en": "Brand history and current generic products remain separate; generic packs are not passed off as DESYREL and a historical label is not described as live supply." } }, { "market": { "zh": "中国大陆、日本、欧盟及其他市场", "en": "Mainland China, Japan, EU and other markets" }, "status": { "zh": "待逐项建立现行监管产品记录", "en": "Current regulatory product records not yet established" }, "detail": { "zh": "不从美国品牌史、通用名或 mg 数字推定其他市场批准、包装、供应、原研/仿制关系或可替代性。", "en": "No approval, pack, supply, originator/generic relationship or interchangeability in another market is inferred from U.S. brand history, generic name or milligram figures." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "曲唑酮是不是安眠药？", "en": "Is trazodone a sleeping pill?" }, "answer": { "zh": "本页所引美国标签适应症是成人重性抑郁障碍。嗜睡是需要阅读和防跌倒的安全线索，不等于网页为任何人确认睡眠用途、时间或片数。实际处方目的和用法必须由负责治疗的团队解释。", "en": "The cited U.S. label indicates major depressive disorder in adults. Somnolence is a safety and fall-prevention cue, not webpage confirmation of a sleep use, time or tablet count for anyone. The treating team must explain the actual prescription purpose and directions." } }, { "question": { "zh": "有刻痕就可以自己掰吗？", "en": "Does a score mean I can split it myself?" }, "answer": { "zh": "不能只看刻痕。不同厂家、强度、片形和标签可能不同；必须按准确 NDC、厂家标签和个人处方核对。网页不把包装或药片外观变成个人掰片方案。", "en": "Do not rely on a score alone. Manufacturer, strength, tablet design and label can differ; check the exact NDC, manufacturer label and prescription. The site does not turn pack or tablet appearance into an individual splitting plan." } }, { "question": { "zh": "DESYREL 包装和这里的通用药包装为什么不同？", "en": "Why does a DESYREL pack differ from the generic packs shown here?" }, "answer": { "zh": "DESYREL 是历史品牌身份；当前四张包装图来自另一份美国通用药标签。共同成分不表示同一厂家、同一包装或当前品牌供应。", "en": "DESYREL is a historical brand identity. The four current pack images come from a separate U.S. generic label. A shared ingredient does not mean the same manufacturer, pack or current brand supply." } } ], "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/desyrel-trazodone/", "en": "https://origindrug.com/en/drugs/desyrel-trazodone/" }, "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." ] }