[{"data":1,"prerenderedAt":163},["ShallowReactive",2],{"drug-daridorexant":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":68,"warnings":78,"renal":86,"monitoring":87,"interactions":88,"review":89,"examples":92,"atc":98,"iran":100,"links":107,"populations":124,"usApproval":158},"daridorexant",1,{"fa":7,"en":8},"داریدورکسانت","Daridorexant","nervous-system",{"fa":11,"en":12},"آنتاگونیست گیرنده اورکسین (DORA)","Dual orexin receptor antagonist",[14],{"name":15,"market":16},"Quviviq","US",[18,19,7],"quviviq","کوویویک",[21,35],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-25","tablet","oral","25 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},25,"mg",false,[16],[32],{"source":33,"section":34},"fda-quviviq","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-50","50 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},50,[16],[42],{"source":33,"section":34},[44],{"id":45,"disease":46,"label":47,"population":50,"type":54,"unit":28,"dose":55,"refs":56,"notes":59},"ins","insomnia",{"fa":48,"en":49},"بی‌خوابی بزرگسال — ۲۵ تا ۵۰ mg ظرف ۳۰ دقیقه پیش از خواب","Insomnia, adults — 25–50 mg within 30 min before bedtime",{"minAge":51},{"value":52,"unit":53},18,"year","fixed",{"perDose":27,"perDoseMax":39,"dosesPerDay":5},[57],{"source":33,"section":58},"2.1",[60],{"text":61,"refs":64},{"fa":62,"en":63},"حداکثر یک بار در شب، دست‌کم ۷ ساعت تا بیداری. نارسایی متوسط کبد حداکثر ۲۵ mg؛ شدید توصیه نمی‌شود.","No more than once a night, ≥7 h before awakening. Moderate hepatic impairment max 25 mg; severe not recommended.",[65,66],{"source":33,"section":58},{"source":33,"section":67},"2.3",[69],{"id":70,"severity":71,"text":72,"refs":75},"ci","block",{"fa":73,"en":74},"نارکولپسی؛ حساسیت به داریدورکسانت (آنژیوادم).","Narcolepsy; hypersensitivity to daridorexant (angioedema).",[76],{"source":33,"section":77},"4",[79],{"text":80,"refs":83},{"fa":81,"en":82},"تضعیف CNS و اختلال عملکرد روز بعد؛ فلج خواب و توهم هیپناگوژیک؛ رفتارهای پیچیده خواب؛ اختلال تنفسی؛ تشدید افسردگی و افکار خودکشی.","CNS depression and next-day impairment; sleep paralysis and hypnagogic hallucinations; complex sleep behaviours; compromised respiratory function; worsening depression and suicidal ideation.",[84],{"source":33,"section":85},"5",[],[],[],{"status":90,"reviewer":91,"date":91},"unverified",null,[93],{"regimen":45,"formulation":22,"input":94,"expect":97},{"ageYears":95,"weightKg":96},40,70,{"perDose":27,"tabletsPerDoseRounded":5,"upperPerDose":39},[99],"N05CJ03",{"status":101,"refs":102},"not-found",[103],{"source":104,"section":105,"url":106},"darooyab-generic","G-5578\u002FDaridorexant","https:\u002F\u002Fwww.darooyab.ir\u002FG-5578\u002FDaridorexant",[108,112,116,119,122],{"kind":109,"url":110,"label":111},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=214985","NDA214985",{"kind":113,"url":114,"label":115},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=3a2d1503-b816-40c9-9fac-7e03c5a3bcef","FDA Quviviq",{"kind":117,"url":118,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa622034.html",{"kind":120,"url":121,"label":99},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N05CJ03",{"kind":123,"url":106,"label":8},"darooyab",{"pregnancy":125,"lactation":134,"pediatric":142,"geriatric":150},{"level":126,"text":127,"quote":130,"refs":131},"caution",{"fa":128,"en":129},"برچسب خطر مشخصی برای بارداری ذکر نکرده یا داده کافی ندارد؛ فقط در صورت لزوم و با نظر پزشک.","Label states no clear risk or has limited data; use only if needed, under medical advice.","Risk Summary There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.",[132],{"source":33,"section":133},"8.1",{"level":126,"text":135,"quote":138,"refs":139},{"fa":136,"en":137},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Daridorexant is present in human breast milk in low amounts.",[140],{"source":33,"section":141},"8.2",{"level":126,"text":143,"quote":146,"refs":147},{"fa":144,"en":145},"برچسب برای کودکان شرط، محدودیت سنی یا نکته دارد؛ جمله برچسب در زیر آمده است.","The label has conditions, age limits or notes for children; the label sentence is quoted below.","The safety and effectiveness of QUVIVIQ have not been established in pediatric patients.",[148],{"source":33,"section":149},"8.4",{"level":126,"text":151,"quote":154,"refs":155},{"fa":152,"en":153},"برچسب: در سالمندان با احتیاط و معمولاً از دوز پایین شروع شود.","Label: use with caution in older adults, usually starting at the low end of the dose range.","Because QUVIVIQ can increase somnolence and drowsiness, patients, particularly the elderly, are at higher risk of falls [see Warnings and Precautions (5.1) ] .",[156],{"source":33,"section":157},"8.5",{"kind":159,"refs":160,"id":111},"NDA",[161],{"source":33,"section":162},"SPL approval \u002F marketing category",1792191536133]