[{"data":1,"prerenderedAt":178},["ShallowReactive",2],{"drug-suvorexant":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":59,"contraindications":84,"warnings":94,"renal":102,"monitoring":103,"interactions":104,"review":105,"examples":108,"atc":114,"iran":116,"usApproval":123,"links":129,"populations":143},"suvorexant",1,{"fa":7,"en":8},"سووورکسانت","Suvorexant","nervous-system",{"fa":11,"en":12},"آنتاگونیست گیرنده اورکسین","Orexin receptor antagonist",[14],{"name":15,"market":16},"Belsomra","US",[18,19,7],"belsomra","بلسومرا",[21,35,43,51],{"id":22,"form":23,"route":24,"label":25,"concentration":26,"markets":30,"refs":31},"tab-5","tablet","oral","5 mg tablet",{"amount":27,"unit":28,"perUnit":23,"scored":29},5,"mg",false,[16],[32],{"source":33,"section":34},"fda-belsomra","3",{"id":36,"form":23,"route":24,"label":37,"concentration":38,"markets":40,"refs":41},"tab-10","10 mg tablet",{"amount":39,"unit":28,"perUnit":23,"scored":29},10,[16],[42],{"source":33,"section":34},{"id":44,"form":23,"route":24,"label":45,"concentration":46,"markets":48,"refs":49},"tab-15","15 mg tablet",{"amount":47,"unit":28,"perUnit":23,"scored":29},15,[16],[50],{"source":33,"section":34},{"id":52,"form":23,"route":24,"label":53,"concentration":54,"markets":56,"refs":57},"tab-20","20 mg tablet",{"amount":55,"unit":28,"perUnit":23,"scored":29},20,[16],[58],{"source":33,"section":34},[60],{"id":61,"disease":62,"label":63,"population":66,"type":70,"unit":28,"dose":71,"refs":72,"notes":75},"ins","insomnia",{"fa":64,"en":65},"بی‌خوابی (شروع یا تداوم خواب) — ۱۰ mg ۳۰ دقیقه قبل از خواب (حداکثر ۲۰ mg)","Insomnia (onset or maintenance) — 10 mg within 30 min of bedtime (max 20 mg)",{"minAge":67},{"value":68,"unit":69},18,"year","fixed",{"perDose":39,"perDoseMax":55,"dosesPerDay":5},[73],{"source":33,"section":74},"2.1",[76],{"text":77,"refs":80},{"fa":78,"en":79},"حداکثر یک بار در شب با دست‌کم ۷ ساعت تا بیداری. با مهارکننده متوسط CYP3A ← ۵ mg؛ با مهارکننده قوی توصیه نمی‌شود.","No more than once per night with at least 7 h before waking. Moderate CYP3A inhibitors → 5 mg; strong inhibitors not recommended.",[81,82],{"source":33,"section":74},{"source":33,"section":83},"2.4",[85],{"id":86,"severity":87,"text":88,"refs":91},"narco","block",{"fa":89,"en":90},"نارکولپسی.","Narcolepsy.",[92],{"source":33,"section":93},"4",[95],{"text":96,"refs":99},{"fa":97,"en":98},"خواب‌آلودگی روز بعد (رانندگی)؛ رفتارهای پیچیده خواب؛ فلج خواب و توهم.","Next-day impairment (driving); complex sleep behaviours; sleep paralysis and hallucinations.",[100],{"source":33,"section":101},"5",[],[],[],{"status":106,"reviewer":107,"date":107},"unverified",null,[109],{"regimen":61,"formulation":36,"input":110,"expect":113},{"ageYears":111,"weightKg":112},50,70,{"perDose":39,"tabletsPerDoseRounded":5,"upperPerDose":55},[115],"N05CJ01",{"status":117,"refs":118},"not-found",[119],{"source":120,"section":121,"url":122},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Suvorexant",{"kind":124,"refs":125,"id":128},"NDA",[126],{"source":33,"section":127},"SPL approval \u002F marketing category","NDA204569",[130,133,137,140],{"kind":131,"url":132,"label":128},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=204569",{"kind":134,"url":135,"label":136},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=e5b72731-1acb-45b7-9c13-290ad12d3951","FDA Belsomra",{"kind":138,"url":139,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa614046.html",{"kind":141,"url":142,"label":115},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N05CJ01",{"pregnancy":144,"lactation":153,"pediatric":161,"geriatric":170},{"level":145,"text":146,"quote":149,"refs":150},"caution",{"fa":147,"en":148},"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 Available data from postmarketing reports with BELSOMRA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.",[151],{"source":33,"section":152},"8.1",{"level":145,"text":154,"quote":157,"refs":158},{"fa":155,"en":156},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Suvorexant and its metabolite, hydroxy suvorexant, are present in low concentrations in breast milk with a relative infant dose of less than 1% following maternal oral administration (see Data ) .",[159],{"source":33,"section":160},"8.2",{"level":162,"text":163,"quote":166,"refs":167},"not-established",{"fa":164,"en":165},"برچسب: ایمنی و اثربخشی در کودکان ثابت نشده است.","Label: safety and effectiveness in children have not been established.","Safety and effectiveness in pediatric patients have not been established.",[168],{"source":33,"section":169},"8.4",{"level":145,"text":171,"quote":174,"refs":175},{"fa":172,"en":173},"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 BELSOMRA can increase drowsiness, patients, particularly the elderly, are at a higher risk of falls [see Warnings and Precautions (5.1) ] .",[176],{"source":33,"section":177},"8.5",1792156196358]