[{"data":1,"prerenderedAt":163},["ShallowReactive",2],{"drug-lemborexant":3},{"id":4,"schemaVersion":5,"name":6,"category":9,"class":10,"brands":13,"synonyms":17,"formulations":20,"regimens":43,"contraindications":70,"warnings":80,"renal":88,"monitoring":89,"interactions":90,"review":91,"examples":94,"atc":100,"iran":102,"usApproval":109,"links":115,"populations":129},"lemborexant",1,{"fa":7,"en":8},"لمبورکسانت","Lemborexant","nervous-system",{"fa":11,"en":12},"آنتاگونیست گیرنده اورکسین (DORA)","Dual orexin receptor antagonist",[14],{"name":15,"market":16},"Dayvigo","US",[18,19,7],"dayvigo","دیویگو",[21,35],{"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-dayvigo","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},[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 — ۵ mg درست پیش از خواب (تا ۱۰ mg)","Insomnia, adults — 5 mg immediately before bedtime (up to 10 mg)",{"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. مهارکننده متوسط\u002Fقوی CYP3A یا القاگر: پرهیز؛ مهارکننده ضعیف: حداکثر ۵ mg. نارسایی متوسط کبد حداکثر ۵ mg؛ شدید توصیه نمی‌شود.","No more than once a night, ≥7 h before awakening. Moderate\u002Fstrong CYP3A inhibitors or inducers: avoid; weak inhibitors: max 5 mg. Moderate hepatic impairment max 5 mg; severe not recommended.",[65,66,68],{"source":33,"section":58},{"source":33,"section":67},"2.2",{"source":33,"section":69},"2.3",[71],{"id":72,"severity":73,"text":74,"refs":77},"narc","block",{"fa":75,"en":76},"نارکولپسی.","Narcolepsy.",[78],{"source":33,"section":79},"4",[81],{"text":82,"refs":85},{"fa":83,"en":84},"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.",[86],{"source":33,"section":87},"5",[],[],[],{"status":92,"reviewer":93,"date":93},"unverified",null,[95],{"regimen":45,"formulation":22,"input":96,"expect":99},{"ageYears":97,"weightKg":98},40,70,{"perDose":27,"tabletsPerDoseRounded":5,"upperPerDose":39},[101],"N05CJ02",{"status":103,"refs":104},"not-found",[105],{"source":106,"section":107,"url":108},"darooyab-generic","search","https:\u002F\u002Fwww.darooyab.ir\u002FSearch?q=Lemborexant",{"kind":110,"refs":111,"id":114},"NDA",[112],{"source":33,"section":113},"SPL approval \u002F marketing category","NDA212028",[116,119,123,126],{"kind":117,"url":118,"label":114},"fda","https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fcder\u002Fdaf\u002Findex.cfm?event=overview.process&ApplNo=212028",{"kind":120,"url":121,"label":122},"dailymed","https:\u002F\u002Fdailymed.nlm.nih.gov\u002Fdailymed\u002FdrugInfo.cfm?setid=7074cb65-77b3-45d2-8e8d-da8dc0f70bfd","FDA Dayvigo",{"kind":124,"url":125,"label":8},"medlineplus","https:\u002F\u002Fmedlineplus.gov\u002Fdruginfo\u002Fmeds\u002Fa620039.html",{"kind":127,"url":128,"label":101},"who-atc","https:\u002F\u002Fatcddd.fhi.no\u002Fatc_ddd_index\u002F?code=N05CJ02",{"pregnancy":130,"lactation":139,"pediatric":147,"geriatric":155},{"level":131,"text":132,"quote":135,"refs":136},"caution",{"fa":133,"en":134},"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 DAYVIGO use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage or adverse maternal or fetal outcomes.",[137],{"source":33,"section":138},"8.1",{"level":131,"text":140,"quote":143,"refs":144},{"fa":141,"en":142},"برچسب: در شیردهی با احتیاط؛ متن برچسب را ببینید.","Label: use with caution while breastfeeding; see the label text.","Risk Summary Available data from a lactation study in 8 women indicates that lemborexant is transferred into the breastmilk of nursing mothers, and the results have established a mean daily infant dose of 0.0029 mg\u002Fkg\u002Fday and a relative infant dose of less than 2% of the maternal dose.",[145],{"source":33,"section":146},"8.2",{"level":131,"text":148,"quote":151,"refs":152},{"fa":149,"en":150},"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 DAYVIGO have not been established in pediatric patients.",[153],{"source":33,"section":154},"8.4",{"level":131,"text":156,"quote":159,"refs":160},{"fa":157,"en":158},"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 DAYVIGO can increase somnolence and drowsiness, patients, particularly the elderly, are at a higher risk of falls [see Warning s and Precautions ( 5.1 )] .",[161],{"source":33,"section":162},"8.5",1792191551722]