Daridorexant 25 mg iyo 50 mg ayaa wanaajiyay natiijooyinka hurdada, iyo daridorexant 50 mg ayaa sidoo kale wanaajiyay shaqada maalintii, dadka qaba hurdo la'aanta, oo leh muuqaal badbaado oo wanaagsan. Dhacdooyinka guud ee dhacdooyinka xunxun waxay barbardhigi jireen kooxaha daawaynta ee dadka waaweyn iyo dadka waaweyn (65 jir iyo ka weyn) qaba hurdo la'aan. Sida la soo sheegay, darídorexant 50 mg ayaa muujisay horumarro tirakoob oo muhiim ah oo ku saabsan dhammaadka aasaasiga ah ee bilawga hurdada iyo dayactirka iyo sidoo kale dhammaadka labaad ee wakhtiga hurdada iyo hurdo maalmeedka.
Muhiimad ahaan, tijaabooyinku waxay ahaayeen kuwii ugu horreeyay ee lagu baaro saameynta daaweynta hurdo la'aanta ee shaqeynta maalintii, iyadoo la adeegsanayo qalab natiijada bukaan-socodka la soo sheegay, oo ay ku jiraan saddex qaybood oo kala duwan (feejignaan / garashada, niyadda, iyo hurdo la'aanta). Daridorexant 50 mg, oo lagu qiimeeyay mid ka mid ah labada tijaabo, ayaa muujiyay horumarro marka la barbar dhigo aasaaska dhammaan goobaha shaqada ee maalintii oo dhan oo leh heer sare oo joogto ah.
Emmanuel Mignot, MD, Professor Cilmi-nafsiga iyo Sayniska Dhaqanka ee Jaamacadda Stanford iyo qoraaga hormuudka ah, ayaa faallo ka bixiyay:
"Dadka hurdo la'aantu hayso waxay inta badan ka cawdaan hawl-maalmeedka oo daciifay. Tani waa arin weyn oo inta badan la iska indhatiro daawaynta hurdo la'aanta, run ahaantiina dawooyin badan oo dhiirigeliya hurdo la'aanta ayaa wax u dhimi karta shaqada maalintii marka ay leeyihiin saameyn hadhaaga ah. Barnaamijkan, ma aha oo kaliya inaan aragno waxtarka daridorexant ee hurdada hurdada, dayactirka iyo tirada hurdada ee bukaanka la soo sheegay, laakiin muhiimad ahaan, qiyaasta 50 mg, maalintii shaqeynta, gaar ahaan qaybta hurdada sida lagu qiyaaso cusub Miisaanka, IDSIQ. Ka qaybqaatayaasha kooxda darídorexant 50 mg ayaa soo sheegay hagaajinta dhinacyo badan oo shaqo maalintii ah, sida lagu qiimeeyay qalabkan cusub ee la sameeyay oo la ansixiyay kaas oo qiimeeyay niyadda, feejignaanta / garashada, iyo hurdo la'aanta. Waa wax lagu farxo in la arko in hurdo la'aanta aan ugu dambeyntii loo arkin dhibaato habeennimo oo keliya balse loo arko inay sabab u tahay silica maalintii."
Waxtarka iyo Natiijooyinka Badbaadada
Daridorexant 50 mg ayaa si weyn u wanaajiyay bilawga hurdada, dayactirka hurdada iyo is-sheegida wadarta wakhtiga hurdada ee bilaha koowaad iyo seddexaad marka loo eego placebo. Saamaynta ugu weyn ayaa lagu arkay qiyaasta ugu sareysa (50 mg), oo ay ku xigto 25 mg, halka qiyaasta 10 mg aysan saameyn weyn ku yeelan. Dhammaan kooxaha daawaynta waxaa la ilaaliyay saamiga heerarka hurdada, si ka duwan natiijooyinka lagu soo warramey agonists benzodiazepine receptor.
Diirada ugu weyn ee tijaabooyinku waxay ahayd in la qiimeeyo saamaynta daridorexant ee shaqaynta maalinta ee bukaanka hurdo la'aanta, sida lagu qiimeeyay Su'aalaha Saamaynta Maalinta Hurdada (IDSIQ). IDSIQ waa qalab bukaan-socod la soo sheegay oo si gaar ah loo soo saaray iyadoo la raacayo tilmaamaha FDA, oo ay ku jiraan gelinta bukaan-socodka, si loo cabbiro shaqada maalintii ee bukaanka hurdo-la'aanta. Dhibcaha hurdada hurdada ee IDSIQ waxaa lagu qiimeeyay inay tahay barta ugu dambeysa ee ugu dambeysa ee labada daraasadood ee muhiimka ah iyo isbarbardhigga placebo oo ay ku jirto xakamaynta badnaanta. Daridorexant 50 mg ayaa muujisay horumar aad u weyn oo tirakoobka ah ee hurdo maalmeedka ee bisha kow iyo bilaha 3. Dhibcaha domain ee hurdada si weyn looma hagaajinin 25 mg labadaba daraasad kasta waqti kasta. Daridorexant 50 mg ayaa sidoo kale wanaajisay dhibcaha dheeraadka ah ee IDSIQ (gargaarka / garaadka domain, domain niyadda) iyo wadarta dhibcaha (p-qiimaha <0.0005 oo ka soo horjeeda placebo aan loo habeynin badnaanta). Hagaajinta shaqada maalintii by daridorexant 50 mg ayaa si tartiib tartiib ah u kordhay saddexdii bilood ee daraasadda.
Dhacdooyinka guud ee dhacdooyinka xun waxay ahaayeen kuwo u dhexeeya kooxaha daawaynta. Dhacdooyinka xunxun ee ka dhacaya in ka badan 5% ka qaybgalayaashu waxay ahaayeen nasopharyngitis iyo madax xanuun. Ma jirin koror ku-tiirsan oo ku yimid dhacdooyinka xun ee kala duwan ee qiyaasta qiyaasta, oo ay ku jiraan hurdo la'aan iyo dhicis. Intaa waxaa dheer, wax ku-tiirsanaan ah, hurdo la'aan soo laabatay ama saameyn ka-noqosho ayaa lagu arkay joojinta kadiska ah ee daaweynta. Kooxaha daawaynta oo dhan, dhacdooyinka xun xun ee keenaya joojinta daawaynta ayaa tiro ahaan aad ugu badan placebo marka loo eego darídorexant.
Martine Clozel, MD, iyo Sarkaalka Sare ee Sayniska ee Idorsia, ayaa faallo ka bixiyay:
"Xogtan oo lagu daabacay The Lancet Neurology waxay muujineysaa qoto dheer ee caddaynta laga keenay barnaamijka horumarinta daridorexant iyo sifooyinka daroogada ee aan aaminsanahay inay sharxayaan natiijooyinka. Daawada waxaa loogu talagalay inay leedahay waxtarka bilawga hurdada iyo dayactirka qiyaasaha ugu wanaagsan ee waxtarka leh iyadoo laga fogaanayo hurdo la'aanta subaxdii. Muuqaalkan, oo ay weheliso xannibaadda siman ee labadaba orexin reseptors - taas oo keeni karta in la joojiyo dabeecadda naxariis-darrada joogtada ah ee hurdo la'aanta - waxay sharxi kartaa horumarka aan ku aragno shaqeynta maalintii oo leh 50 mg of daridorexant."
Daridorexant hurdo la'aan
Hurdo la'aanta waxaa lagu gartaa dhibaatooyin bilawga ama ilaalinta hurdada waxayna la xiriirtaa murugo ama daciifnimo shaqada maalintii. Cabashooyin kala duwan oo maalintii ah, laga bilaabo daal iyo tamar yaraan ilaa niyadda beddelka iyo dhibaatooyinka garashada, waxaa soo tebiyay dadka qaba hurdo la'aan.
Hurdo la'aantu waxay la xiriirtaa habka toosinta firfircoonida.
Daridorexant, novel dual orexin antagonist , waxaa nashqadeeyay oo ay u samaysay Idorsia daawaynta hurdo la'aanta. Daridorexant wuxuu bartilmaameedsadaa sifada toosan ee xad dhaafka ah ee hurdo la'aanta iyadoo xannibaysa dhaqdhaqaaqa orexin. Daridorexant wuxuu si gaar ah u bartilmaameedsadaa nidaamka orexin isagoo si tartan ah ugu xidha labada reseptors, taas oo dib u celinaysa dhaqdhaqaaqa orexin.
Daridorexant waa FDA lagu ansixiyey gudaha Maraykanka iyada oo hoos imanaysa magaca ganacsiga QUVIVIQ™ waxayna diyaar noqon doontaa ka dib jadwalka Maamulka Dhaqangelinta Maandooriyaha Mareykanka ee Maajo 2022.
MAXAA LAGU QAADAYAA MAQAALKAN:
- In this program, not only did we see efficacy of daridorexant on sleep induction, maintenance and patient-reported sleep quantity and quality, but importantly, at the dose of 50 mg, on daytime functioning, notably in the sleepiness domain as measured with a new scale, the IDSIQ.
- This profile, together with the equal blockade of both orexin receptors – which may lead to an inhibition of the chronic sympathetic hyperactivity characteristic of insomnia – may explain the improvement we see in daytime functioning with 50 mg of daridorexant.
- A major focus of the trials was to evaluate the impact of daridorexant on daytime functioning in patients with insomnia, as assessed by the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
