Ingxelo eNtsha kwiiMpawu zoBusuku kunye nokuSebenza kweMini kubantu abadala abane-Insomnia

Ibhalwe ngu umhleli

Idorsia Pharmaceuticals, US Inc. namhlanje ibhengeze ukupapashwa "Ukhuseleko kunye nokusebenza kakuhle kwe-daridorexant kwizigulane ezine-insomnia disorder: iziphumo ezivela kwi-multicenter, i-randomized, i-double-blind, i-placebo-controlled, i-placebo-controlled, izilingo zesigaba se-3" kwi-Lancet Neurology.

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I-Daridorexant 25 mg kunye ne-50 mg iziphumo zokulala eziphuculweyo, kunye ne-daridorexant ye-50 mg iphinde yaphucula ukusebenza kwemini, kubantu abanesifo sokulala, kunye neprofayili ekhuselekileyo yokhuseleko. Iziganeko ezipheleleyo zeziganeko ezimbi zafaniswa phakathi kwamaqela onyango kubantu abadala kunye nabantu abadala (abaneminyaka eyi-65 nangaphezulu) kunye nokulala. Njengoko kuxeliwe, i-daridoexant ye-50 mg ibonise uphuculo olubalulekileyo lwezibalo kwiindawo eziphambili zokuphela kokulala kunye nokugcinwa kunye nesiphelo sesibini sokulala okupheleleyo kunye nokulala emini.

Okubalulekileyo, iimvavanyo zaba zezokuqala ukuphanda umphumo wonyango lokungalali ekusebenzeni kwemini, usebenzisa isixhobo esiqinisekisiweyo seziphumo ezichazwe ngesigulane, esibandakanya imimandla emithathu eyahlukeneyo (isilumkiso / ukuqonda, isimo sengqondo kunye nokulala). I-Daridorexant 50 mg, evandlakanywe kwelinye lezilingo ezimbini, ibonise uphuculo xa kuthelekiswa nesiseko kuyo yonke imimandla yokusebenza kwemini enezinga eliphezulu lokuhambelana.

U-Emmanuel Mignot, MD, uNjingalwazi weNzululwazi yeNgqondo kunye nokuziphatha kwiYunivesithi yaseStanford kunye nombhali okhokelayo, wathi:

“Abantu abaphuthelwa basoloko bekhalazela ukungasebenzi kakuhle kwasemini. Lo ngowona mcimbi uphambili uhlala ungahoywa ekunyangeni ukuphuthelwa kwaye enyanisweni uninzi lweziyobisi ezikhuthaza ukulala zinokuphazamisa ukusebenza kwasemini xa zineziphumo ezishiyekileyo. Kule nkqubo, asizange sibone kuphela ukusebenza kwe-daridorexant ekufakweni kokulala, ukugcinwa kunye nobuninzi bokulala obuxelwe yisigulane kunye nomgangatho, kodwa okubalulekileyo, kwi-dose ye-50 mg, ekusebenzeni kwemini, ngokukodwa kwi-domain yokulala njengoko ilinganiswe nentsha. isikali, IDSIQ. Abathathi-nxaxheba kwiqela le-daridorexant ye-50 mg babike uphuculo kwiinkalo ezininzi zokusebenza kwemini, njengoko kuhlolwe ngulo mshini osanda kuphuhliswa kunye nokuqinisekiswa kokuvavanya isimo sengqondo, ukuphaphama / ukuqonda, kunye nokulala. Kuyavuyisa ukubona ukuba ekugqibeleni ukungalali akujongwa njengengxaki yasebusuku kuphela kodwa njengonobangela wokubandezeleka emini.”

UkuSebenza kunye neziPhumo zoKhuseleko

I-Daridorexant i-50 mg iphucule kakhulu ukuqala kokulala, ukugcinwa kokulala kunye nokuzixela ixesha lokulala elipheleleyo kwiinyanga enye kunye nezintathu xa kuthelekiswa ne-placebo. Isiphumo esikhulu kunazo zonke sabonwa nge-dose ephezulu (50 mg), ilandelwa yi-25 mg, ngelixa i-10 mg dose ayinayo impembelelo ebalulekileyo. Kuwo onke amaqela onyango umlinganiselo wezigaba zokulala zigcinwe, ngokungafaniyo neziphumo ezichazwe kunye ne-benzodiazepine receptor agonists.

Ingqwalasela enkulu yezilingo yayikukuvavanya impembelelo ye-daridorexant ekusebenzeni kwasemini kwizigulane ezinokulala, njengoko kuhlolwe yi-Insomnia Daytime Symptoms and Impact Questionnaire (IDSIQ). I-IDSIQ iyisixhobo esiqinisekisiweyo seziphumo ezichazwe kwisigulane esiphuhliswe ngokukodwa ngokwemigaqo ye-FDA, kubandakanywa igalelo lesigulane, ukulinganisa ukusebenza kwemini kwizigulane ezinokulala. Inqaku lesizinda sokulala le-IDSIQ livandlakanywe njengesiphelo sesibini esiphambili kuzo zombini izifundo ezibalulekileyo kunye nokuthelekisa kwi-placebo kubandakanywa ulawulo lokuphindaphinda. I-Daridorexant i-50 mg ibonise uphuculo olubalulekileyo lwe-statistically ebuthongweni bemini kwinyanga enye kunye nenyanga ye-3. Umlinganiselo wesizinda sokulala awuzange uphuculwe kakhulu kwi-25 mg kuyo nayiphi na isifundo kwiyiphi na ixesha. I-Daridorexant 50 mg nayo yaphucula amanqaku e-IDSIQ eyongezelelweyo ye-domain (i-alert / cognition domain, i-mood domain) kunye namanqaku apheleleyo (i-p-values ​​<0.0005 ngokubhekiselele kwi-placebo engalungiswanga ukuphindaphinda). Ukuphuculwa kokusebenza kwemini nge-daridorexant 50 mg ngokuqhubekayo kwanda kwiinyanga ezintathu zophononongo.

Iziganeko ezipheleleyo zeziganeko ezimbi zazithelekiseka phakathi kwamaqela onyango. Iziganeko ezimbi ezenzeka ngaphezu kwe-5% yabathathi-nxaxheba babeyi-nasopharyngitis kunye nentloko. Khange kubekho ukonyuka okuxhomekeke kwithamo kwiziganeko ezibi kulo lonke uluhlu lwedosi, kubandakanywa ukungabikho kwengqondo kunye nokuwa. Ngaphaya koko, akukho kuxhomekeka, ukuphuthelwa kwakhona okanye iziphumo zokurhoxisa zabonwa ekuyekisweni konyango ngequbuliso. Kuwo wonke amaqela onyango, iziganeko ezimbi ezikhokelela ekuyekisweni konyango zazihlala ziqhelekile nge-placebo kune-daridoxant.

UMartine Clozel, MD, kunye neGosa eliyiNtloko lezeNzululwazi lase-Idorsia, uthe:

“Ezi datha zipapashwe kwiLancet Neurology ziqaqambisa ubunzulu bobungqina obuveliswe kwinkqubo yophuhliso lwe-daridoexant kunye neempawu zechiza endikholelwa ukuba zichaza iziphumo. Ichiza laliyilelwe ukuba libe nempumelelo ekuqalekeni kokulala kunye nokugcinwa kwiidosi ezisebenzayo ngokufanelekileyo ngelixa linqanda ukulala kwasekuseni okushiyekileyo. Le profayili, kunye ne-blockade elinganayo yazo zombini i-orexin receptors-enokuthi ikhokelele ekuthintelweni kweempawu zovelwano ezingapheliyo zokuphuthelwa - inokuchaza ukuphucuka esikubonayo ekusebenzeni kwasemini nge-50 mg ye-daridoxant.

I-Daridexant kwi-insomnia

I-Insomnia disorder ibonakala ngobunzima bokuqalisa okanye ukugcina ubuthongo kwaye inxulunyaniswa noxinzelelo okanye ukukhubazeka ekusebenzeni kwasemini. Uluhlu olubanzi lwezikhalazo zemini, ukusuka ekudinweni kunye nokunciphisa amandla ekuguquleni imizwelo kunye nobunzima bokuqonda, kubikwa ngabantu abanesifo sokulala.

Ukuphuthelwa kunxulunyaniswa nenkqubo yokuvuka ngokugqithisileyo.

I-Daridorexant, i-novel dual orexin receptor antagonist, yenzelwe kwaye yaphuhliswa yi-Idorsia kunyango lokungalali. I-Daridorexant ijolise kuphawu lokuphaphama okugqithisileyo kokuphuthelwa ngokuthintela umsebenzi we-orexin. I-Daridorexant ijolise ngokukodwa kwinkqubo ye-orexin ngokuzibophelela ngokukhuphisana nazo zombini ii-receptors, ngaloo ndlela ivalela umva umsebenzi we-orexin.

I-Daridorexant yi-FDA evunyiweyo e-US phantsi kwegama lokurhweba i-QUVIVIQ™ kwaye iya kufumaneka emva kokucwangciswa kwe-US Drug Enforcement Administration ngoMeyi ka-2022.

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Umhleli oyintloko we-eTurboNew nguLinda Hohnholz. Uzinze kwi-eTN HQ e-Honolulu, eHawaii.

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