Lipoti Latsopano Lokhudza Zizindikiro Za Usiku ndi Kugwira Ntchito Masana Kwa Akuluakulu Omwe Ali ndi Insomnia

Written by mkonzi

Idorsia Pharmaceuticals, US Inc. lero adalengeza kufalitsidwa kwa "Chitetezo ndi mphamvu ya daridoexant kwa odwala omwe ali ndi vuto la kusowa tulo: zotsatira za maulendo awiri a multicenter, randomized, double-blind, placebo controlled, phase 3" mu The Lancet Neurology.

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Daridorexant 25 mg ndi 50 mg zotsatira zabwino za kugona, ndipo daridoexant 50 mg imathandizanso kugwira ntchito kwa masana, mwa anthu omwe ali ndi vuto la kusowa tulo, omwe ali ndi mbiri yabwino yachitetezo. Chiwopsezo chonse chazovuta zoyipa chinali chofananira pakati pamagulu azachipatala mwa akulu ndi achikulire (azaka 65 ndi kupitilira) omwe ali ndi vuto la kusowa tulo. Monga momwe tafotokozera, daridoexant 50 mg inawonetsa kusintha kwakukulu kwachiwerengero chakumapeto koyambirira kwa kugona ndi kukonzanso komanso mapeto achiwiri a nthawi yogona komanso kugona kwa masana.

Chofunika kwambiri, mayeserowo anali oyamba kufufuza zotsatira za chithandizo cha kusowa tulo pakugwira ntchito masana, pogwiritsa ntchito chida chovomerezeka cha zotsatira za odwala, chomwe chimaphatikizapo madera atatu osiyanasiyana (chenjezo / kuzindikira, maganizo, ndi kugona). Daridorexant 50 mg, yomwe inayesedwa mu imodzi mwa mayesero awiriwa, inasonyeza kusintha poyerekeza ndi zoyambira pamadera onse ogwira ntchito masana omwe ali ndi mlingo wapamwamba wokhazikika.

Emmanuel Mignot, MD, Pulofesa wa Psychiatry and Behavioral Sciences ku yunivesite ya Stanford ndi wolemba wamkulu, anati:

“Anthu amene ali ndi vuto la kusowa tulo nthawi zambiri amadandaula kuti amalephera kugwira ntchito masana. Ili ndi vuto lalikulu lomwe nthawi zambiri silimanyalanyazidwa pochiza kusowa tulo ndipo kwenikweni mankhwala ambiri olimbikitsa kugona amatha kusokoneza kugwira ntchito kwa masana akakhala ndi zotsalira. Mu pulogalamuyi, sikuti tinangowona mphamvu ya daridoexant pakugona, kukonza komanso kuchuluka kwa tulo ndi khalidwe la odwala, koma chofunika kwambiri, pa mlingo wa 50 mg, pakugwira ntchito masana, makamaka mu malo ogona monga momwe amachitira ndi zatsopano. scale, IDSIQ. Ogwira nawo ntchito mu gulu la daridoexant 50 mg adanenanso za kusintha kwazinthu zambiri za ntchito ya masana, monga momwe zimayendera ndi chida chatsopanochi komanso chovomerezeka chomwe chinayesa maganizo, tcheru / kuzindikira, ndi kugona. N’zosangalatsa kuona kuti vuto la kusowa tulo silimangoonedwa ngati vuto la usiku komanso chifukwa cha kuvutika masana.”

Kuchita Bwino ndi Chitetezo Zotsatira

Daridorexant 50 mg imathandizira kwambiri kugona, kukonza tulo komanso kudziwonetsera nokha nthawi yogona pa mwezi umodzi ndi itatu poyerekeza ndi placebo. Mphamvu yayikulu kwambiri idawonedwa ndi mlingo wapamwamba kwambiri (50 mg), wotsatiridwa ndi 25 mg, pomwe mlingo wa 10 mg sunakhale ndi zotsatirapo zazikulu. M'magulu onse ochiritsira chiwerengero cha magawo ogona chinasungidwa, mosiyana ndi zomwe zinanenedwa ndi benzodiazepine receptor agonists.

Cholinga chachikulu cha mayeserowa chinali kuyesa zotsatira za daridoexant pakugwira ntchito masana kwa odwala omwe ali ndi vuto la kusowa tulo, monga momwe amachitira ndi Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). IDSIQ ndi chida chotsimikizika cha zotsatira za odwala chomwe chimapangidwa molingana ndi malangizo a FDA, kuphatikiza kuyikapo kwa odwala, kuyeza kugwira ntchito kwa masana kwa odwala omwe ali ndi vuto la kugona. Chiwerengero cha tulo cha IDSIQ chinawunikidwa ngati chomaliza chachiwiri m'maphunziro onse ofunikira komanso kuyerekeza ndi placebo kumaphatikizapo kuwongolera kuchulukana. Daridorexant 50 mg inawonetsa kusintha kwakukulu kwa chiwerengero cha kugona kwa masana pa mwezi umodzi ndi mwezi wa 3. Malo ogona ogona sanali bwino kwambiri pa 25 mg mu phunziro lililonse pa nthawi iliyonse. Daridorexant 50 mg inakonzanso zowonjezera za IDSIQ domain (chidziwitso / chidziwitso, domain domain) ndi chiwerengero chonse (p-values ​​<0.0005 motsutsana ndi placebo osasinthidwa kuti achuluke). Kupititsa patsogolo kwa ntchito ya masana ndi daridoexant 50 mg pang'onopang'ono kumawonjezeka pa miyezi itatu ya phunzirolo.

Chiwopsezo chonse cha zochitika zoyipa zinali zofananira pakati pamagulu amankhwala. Zoyipa zomwe zimachitika mwa opitilira 5% mwa omwe adatenga nawo gawo anali nasopharyngitis ndi mutu. Panalibe kuwonjezeka kodalira mlingo pazochitika zovuta pamtundu uliwonse wa dosing, kuphatikizapo kugona ndi kugwa. Komanso, palibe kudalira, kusowa tulo kapena kukomoka komwe kunachitika pambuyo posiya chithandizo mwadzidzidzi. Pamagulu onse ochizira, zochitika zoyipa zomwe zimapangitsa kuti chithandizo chisiyidwe chinali pafupipafupi kwambiri ndi placebo kuposa daridoxant.

Martine Clozel, MD, ndi Chief Scientific Officer ku Idorsia, anati:

"Zolemba izi zofalitsidwa mu The Lancet Neurology zikuwonetsa kuzama kwa umboni wopangidwa mu pulogalamu yachitukuko ya daridoexant ndi katundu wamankhwala omwe ndimakhulupirira kuti amafotokoza zotsatira zake. Mankhwalawa adapangidwa kuti akhale ndi mphamvu pakugona koyambilira komanso kukonza pamiyeso yabwino kwambiri ndikupewa kugona kotsalira m'mawa. Mbiriyi, limodzi ndi kutsekeka kofanana kwa onse orexin zolandilira - zomwe zingayambitse kuletsa kwachisoni kulephera kugona - zitha kufotokozera kusintha komwe timawona pakugwira ntchito masana ndi 50 mg ya daridoxant. "

Daridoexant mu kusowa tulo

Matenda a kusowa tulo amadziwika ndi zovuta kuyambitsa kapena kusunga tulo ndipo amagwirizanitsidwa ndi kupsinjika maganizo kapena kuwonongeka kwa ntchito masana. Madandaulo osiyanasiyana a masana, kuyambira kutopa ndi kuchepa kwa mphamvu mpaka kusintha kwa malingaliro ndi zovuta zachidziwitso, zimanenedwa ndi anthu omwe ali ndi vuto la kugona.

Kusagona tulo kumayenderana ndi kudzuka mopitirira muyeso.

Daridorexant, wotsutsa wapawiri orexin receptor antagonist, adapangidwa ndikupangidwa ndi Idorsia pochiza kusowa tulo. Daridorexant imayang'ana kudzuka kwambiri kwa kusowa tulo poletsa ntchito ya orexin. Daridorexant imayang'ana makamaka dongosolo la orexin pomanga mopikisana ndi zolandilira zonse ziwiri, motero kutsekereza ntchito ya orexin.

Daridoexant ndi FDA yovomerezeka ku US pansi pa dzina la malonda QUVIVIQ™ ndipo ipezeka potsatira ndondomeko ya US Drug Enforcement Administration mu May 2022.

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mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

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