Umbiko Omusha Ngezimpawu Zasebusuku Nokusebenza Kwasemini Kwabantu Abadala Abanokuqwasha

Ibhalwe ngu umhleli

I-Idorsia Pharmaceuticals, US Inc. namuhla imemezele ukushicilelwa "Ukuphepha nokusebenza kwe-daridoxant ezigulini ezinenkinga yokuqwasha: imiphumela evela ku-multicenter, randomized, double-blind, double-blind, placebo-controlled, ukuhlolwa kwesigaba sesi-3" ku-Lancet Neurology.

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I-Daridorexant 25 mg kanye ne-50 mg imiphumela yokulala ethuthukisiwe, kanye ne-daridorexant 50 mg nayo yathuthukisa ukusebenza kwasemini, kubantu abanenkinga yokuqwasha, enephrofayili yokuphepha evumayo. Isigameko esiphelele sezehlakalo ezimbi sasiqhathaniswa phakathi kwamaqembu okwelapha kubantu abadala kanye nabantu abadala (abaneminyaka engu-65 nangaphezulu) abanokuqwasha. Njengoba kubikiwe, i-daridoexant 50 mg ibonise ukuthuthukiswa okuphawulekayo kwezibalo ekugcineni okuyinhloko kokuqala nokugcinwa kokulala kanye neziphetho zesibili zesikhathi sokulala esiphelele kanye nokulala kwasemini.

Okubalulekile, izivivinyo zaba ngezokuqala ukuphenya umphumela wokwelashwa kokuqwasha ekusebenzeni kwasemini, kusetshenziswa ithuluzi eliqinisekisiwe lemiphumela ebikwe isiguli, elihlanganisa izizinda ezintathu ezihlukene (ukuqwashisa/ukuqaphela, isimo sengqondo, nokulala). I-Daridorexant 50 mg, eyahlolwa kwesinye sezivivinyo ezimbili, ibonise ukuthuthukiswa uma kuqhathaniswa nesisekelo kuzo zonke izizinda zokusebenza zasemini nezinga eliphezulu lokuvumelana.

U-Emmanuel Mignot, MD, uProfessor wePsychiatry and Behavioral Science eStanford University kanye nombhali oholayo, ubeke amazwana:

“Abantu abanenkinga yokuqwasha bavame ukukhala ngokungasebenzi kahle emini. Lena inkinga enkulu evame ukunganakwa ekwelapheni ukuqwasha futhi empeleni izidakamizwa eziningi ezikhuthaza ukulala zingaphazamisa ukusebenza kwasemini uma zinemiphumela eyinsalela. Kulolu hlelo, asibonanga nje kuphela ukusebenza kahle kwe-daridorexant ekungenisweni kokulala, ukugcinwa kanye nenani lokulala elibikwe isiguli kanye nekhwalithi, kodwa okubalulekile, kumthamo we-50 mg, ekusebenzeni kwasemini, ikakhulukazi esizindeni sokulala njengoba kulinganiswa nentsha. isikali, i-IDSIQ. Abahlanganyeli eqenjini le-daridorexant 50 mg babike ukuthuthukiswa kwezici eziningi zokusebenza kwasemini, njengoba kuhlolwe yile nsimbi esanda kuthuthukiswa futhi eqinisekisiwe ehlola isimo sengqondo, ukuqapha / ukuqonda, nokulala. Kuyajabulisa ukubona ukuthi ukuqwasha ekugcineni akubhekwa njengenkinga yasebusuku kuphela kodwa njengembangela yokuhlupheka emini.”

Ukusebenza kahle kanye nemiphumela yokuphepha

I-Daridorexant 50 mg ithuthukise kakhulu ukuqala kokulala, ukugcinwa kokulala kanye nesikhathi sokulala esiphelele sokuzibika ezinyangeni zokuqala nezintathu uma kuqhathaniswa ne-placebo. Umphumela omkhulu wabonwa ngomthamo omkhulu kakhulu (50 mg), ulandelwa ngu-25 mg, kuyilapho umthamo we-10 mg ungazange ube nomphumela ophawulekayo. Kuwo wonke amaqembu okwelapha izilinganiso zezigaba zokulala zagcinwa, ngokungafani nokutholakele okubikwe ngama-agonists e-benzodiazepine receptor.

Okugxilwe kakhulu kokuhlolwa kwakuwukuhlola umthelela we-daridorexant ekusebenzeni kwasemini ezigulini ezinokuqwasha, njengoba kuhlolwe Uhlu Lwemibuzo Lwezimpawu Ze-Insomnia Daytime and Impacts Questionnaire (IDSIQ). I-IDSIQ iyithuluzi lemiphumela elibikwe ngesiguli eliqinisekisiwe elakhiwe ngokuqondile ngokuvumelana neziqondiso ze-FDA, okuhlanganisa okokufaka kwesiguli, ukukala ukusebenza kwasemini ezigulini ezinokuqwasha. Isikolo sesizinda sokulala se-IDSIQ sihlaziywe njengesiphetho sesibili esiyinhloko kuzo zombili izifundo ezibalulekile kanye nokuqhathaniswa ne-placebo okufakiwe ukulawula kokuphindaphindeka. I-Daridorexant 50 mg ibonise ukuthuthukiswa okuphawulekayo kwezibalo zokulala emini ngenyanga eyodwa kanye nenyanga ye-3. Isikolo sesizinda sokulala asizange sithuthukiswe kakhulu ku-25 mg kunoma yisiphi isifundo kunoma yisiphi isikhathi sesikhathi. I-Daridorexant 50 mg iphinde yathuthukisa amaphuzu esizinda se-IDSIQ engeziwe (isizinda sokuxwayisa/ukubona, isizinda semizwa) kanye nenani eliphelele (amanani we-p <0.0005 uma kuqhathaniswa ne-placebo engalungiswanga ngokuphindaphinda). Ukuthuthukiswa kokusebenza kwasemini nge-daridorexant 50 mg kukhuphuke kancane kancane phakathi nezinyanga ezintathu zocwaningo.

Isigameko esiphelele sezehlakalo ezimbi sasiqhathaniswa phakathi kwamaqembu okwelapha. Izenzakalo ezimbi ezenzeka ngaphezu kwe-5% yabahlanganyeli kwakuyi-nasopharyngitis nekhanda elibuhlungu. Akubangakho ukunyuka okuncike kumthamo ezenzakalweni ezimbi kulo lonke uhla lokudotshwa, okuhlanganisa ukulala nokuwa. Ngaphezu kwalokho, akukho ukuncika, ukuqwasha kabusha noma imiphumela yokuhoxa ebonwe lapho kuyekiswa ukwelashwa kungazelelwe. Kuwo wonke amaqembu okwelapha, izehlakalo ezimbi eziholela ekuyekisweni kokwelashwa zazivame kakhulu ngenombolo nge-placebo kune-daridoxant.

UMartine Clozel, MD, kanye neChief Scientific Officer yase-Idorsia, baphawule:

“Le datha eshicilelwe ku-Lancet Neurology igqamisa ukujula kobufakazi okukhiqizwa ohlelweni lokuthuthukisa i-daridoexant kanye nezakhiwo zomuthi engikholelwa ukuthi zichaza imiphumela. Umuthi wawuklanyelwe ukuthi ube nempumelelo ekuqaliseni kokulala kanye nokugcinwa kahle ngemithamo esebenza kahle kakhulu kuyilapho ugwema ukulala kwasekuseni okuyinsalela. Le phrofayili, kanye nokuvinjwa okulinganayo kwakho kokubili kwe-orexin receptors - okungase kuholele ekuvinjweni kwesici esingapheli sokuzwelana nokuqwasha - kungase kuchaze ukuthuthuka esikubonayo ekusebenzeni kwasemini ngo-50 mg we-daridoxant. "

I-Daridexant ekuqwaleni

I-Insomnia disorder ibonakala ngobunzima bokuqalisa noma ukugcina ubuthongo futhi ihlotshaniswa nokucindezeleka noma ukukhubazeka ekusebenzeni kwasemini. Izinhlobonhlobo zezikhalazo zasemini, kusukela ekukhathaleni nokuncipha kwamandla kuya ekushintsheni kwemizwelo kanye nobunzima bokuqonda, kubikwa ngabantu abanokuqwasha.

Ukuqwasha kuhlotshaniswa nesistimu yokuvuka esebenza ngokweqile.

I-Daridorexant, umphikisi wenoveli we-orexin receptor, yaklanywa futhi yathuthukiswa yi-Idorsia yokwelapha ukuqwasha. I-Daridorexant iqondise isici sokuphaphama ngokweqile sokuqwasha ngokuvimbela umsebenzi we-orexin. I-Daridorexant iqondise ngokuqondile uhlelo lwe-orexin ngokubopha ngokuncintisana nawo womabili ama-receptors, ngaleyo ndlela ivimbe ngokubuyisela umuva umsebenzi we-orexin.

I-Daridorexant iyi-FDA egunyazwe e-US ngaphansi kwegama lokuhweba i-QUVIVIQ™ futhi izotholakala ngemva kokuhlelwa yi-US Drug Enforcement Administration ngoMeyi 2022.

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