ʻO Daridorexant 25 mg a me 50 mg i hoʻomaikaʻi i nā hopena hiamoe, a me ka daridorexant 50 mg hoʻi i hoʻomaikaʻi i ka hana ʻana i ke ao, i nā poʻe me ka maʻi insomnia, me kahi kūlana palekana maikaʻi. Ua hoʻohālikelike ʻia ka nui o nā hanana ʻino ma waena o nā hui lapaʻau i nā pākeke a me nā poʻe ʻelemakule (mau makahiki 65 a ʻoi aku) me ka insomnia. E like me ka mea i hōʻike ʻia, ua hōʻike ʻo daridorexant 50 mg i nā hoʻomaikaʻi koʻikoʻi i ka helu ʻana i nā hopena mua o ka hoʻomaka ʻana o ka hiamoe a me ka mālama ʻana a me nā hope lua o ka manawa hiamoe a me ka hiamoe o ke ao.

ʻO ka mea nui, ʻo nā hoʻokolohua ka mea mua e noiʻi i ka hopena o ka mālama ʻana i ka insomnia i ka hana ʻana i ke ao, me ka hoʻohana ʻana i kahi mea hana hopena i hōʻike ʻia e ka mea maʻi, ʻo ia hoʻi ʻekolu mau kikowaena like ʻole (alert/cognition, mood, and sleepiness). ʻO Daridorexant 50 mg, i loiloi ʻia i loko o kekahi o nā hoʻokolohua ʻelua, hōʻike i ka hoʻomaikaʻi ʻana i hoʻohālikelike ʻia me ka baseline ma nā wahi āpau e hana ana i nā lā āpau me kahi kiʻekiʻe o ke kūlike.

Ua ʻōlelo ʻo Emmanuel Mignot, MD, Polofesa o Psychiatry a me Behavioral Science ma Stanford University a me ka mea kākau alakaʻi:

"Hoʻopiʻi pinepine ka poʻe me ka insomnia i ka hana ʻino i ke ao. He pilikia koʻikoʻi kēia i mālama ʻole ʻia i ka mālama ʻana i ka insomnia a ʻoiai ʻo ka nui o nā lāʻau lapaʻau e hoʻolalelale ana i ka hiamoe hiki ke hoʻopilikia i ka hana ʻana i ke ao ke loaʻa nā hopena i koe. Ma kēia papahana, ʻaʻole wale mākou i ʻike i ka maikaʻi o ka daridorexant ma ka hoʻoulu ʻana i ka hiamoe, ka mālama ʻana a me ka nui a me ka maikaʻi o ka hiamoe i hōʻike ʻia e ka mea maʻi, akā ʻo ka mea nui, ma ke ʻano o 50 mg, i ka hana ʻana i ke ao, ʻo ia hoʻi i ka pae hiamoe e like me ke ana ʻana me kahi mea hou. pālākiō, ka IDSIQ. Ua hōʻike ka poʻe i komo i ka daridorexant 50 mg i ka hoʻomaikaʻi ʻana i nā ʻano he nui o ka hana ʻana i ke ao, e like me ka loiloi ʻia e kēia mea hana hou a hoʻopaʻa ʻia e loiloi i ke ʻano, ka makaʻala / ʻike, a me ka hiamoe. He mea hauʻoli ka ʻike ʻana ʻaʻole ʻike wale ʻia ka insomnia ma ke ʻano he pilikia i ka pō akā ma ke kumu o ka ʻeha i ke ao.

Nā hopena maikaʻi a me ka palekana

ʻO Daridorexant 50 mg ka mea i hoʻomaikaʻi maikaʻi ʻia i ka hoʻomaka ʻana o ka hiamoe, ka mālama ʻana i ka hiamoe a me ka hōʻike ponoʻī ʻana i ka manawa hiamoe i nā mahina hoʻokahi a me ʻekolu i hoʻohālikelike ʻia me kahi placebo. Uaʻikeʻia ka hopena nui loa me ka nui loa (50 mg), i ukaliʻia e 25 mg,ʻoiaiʻaʻole i loaʻa ka hopena nui o ka 10 mg. I loko o nā pūʻulu lapaʻau a pau, mālama ʻia nā ʻāpana o nā pae hiamoe, ʻokoʻa i nā ʻike i hōʻike ʻia me nā agonist receptor benzodiazepine.

ʻO kahi manaʻo nui o nā hoʻokolohua ʻo ia ka loiloi i ka hopena o ka daridorexant i ka hana o ke ao i nā maʻi me ka insomnia, e like me ka loiloi ʻia e ka Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). ʻO ka IDSIQ kahi mea hana hopena i hōʻike ʻia e ka mea maʻi i kūkulu pono ʻia e like me nā alakaʻi FDA, me ka hoʻokomo ʻana o ka mea maʻi, e ana i ka hana o ke ao i nā mea maʻi me ka insomnia. Ua loiloi ʻia ka helu wahi moe o ka IDSIQ ma ke ʻano he kumu koʻikoʻi koʻikoʻi ma nā haʻawina pivotal ʻelua a me ka hoʻohālikelike ʻana i kahi placebo i hoʻopili ʻia ka mana no ka lehulehu. Ua hōʻike ʻo Daridorexant 50 mg i ka hoʻomaikaʻi nui ʻana i ka hiamoe ʻana i ke ao i ka mahina hoʻokahi a me ka mahina 3. ʻAʻole i hoʻomaikaʻi maikaʻi ʻia ka helu domain sleepiness ma 25 mg i kēlā me kēia haʻawina i kēlā me kēia manawa. Ua hoʻomaikaʻi hou ʻo Daridorexant 50 mg i nā helu IDSIQ hou aʻe (kahi makaʻala/cognition domain, mood domain) a me ka huina helu (p-values <0.0005 versus placebo ʻaʻole i hoʻoponopono ʻia no ka lehulehu). ʻO ka hoʻomaikaʻi ʻana i ka hana o ke ao e daridorexant 50 mg i hoʻonui nui ʻia i nā mahina ʻekolu o ke aʻo ʻana.

Ua hoʻohālikelike ʻia ka nui o nā hanana ʻino ma waena o nā hui lapaʻau. ʻO nā hanana ʻino i loaʻa ma mua o 5% o nā mea komo he nasopharyngitis a me ke poʻo. ʻAʻohe piʻi i hilinaʻi nui ʻia i nā hanana ʻino ma waena o ka pae dosing, me ka hiamoe a me ka hāʻule. Eia kekahi, ʻaʻohe hilinaʻi, rebound insomnia a i ʻole nā hopena withdrawal i ʻike ʻia ma ka hoʻopau koke ʻana o ka mālama ʻana. Ma waena o nā pūʻulu lapaʻau, ʻoi aku ka nui o nā hanana ʻino e hiki ai i ka hoʻopau ʻana i ka mālama ʻana me ka placebo ma mua o ka daridorexant.

Ua ʻōlelo ʻo Martine Clozel, MD, a me Luna Nui ʻepekema o Idorsia:

"ʻO kēia mau ʻikepili i paʻi ʻia ma The Lancet Neurology e hōʻike ana i ka hohonu o nā hōʻike i hana ʻia i ka papahana hoʻomohala daridorexant a me nā waiwai o ka lāʻau aʻu i manaʻoʻiʻo ai e wehewehe i nā hopena. Ua hoʻolālā ʻia ka lāʻau lapaʻau e loaʻa ka hopena no ka hoʻomaka ʻana o ka hiamoe a me ka mālama ʻana i nā ʻano kūpono maikaʻi loa me ka pale ʻana i ke koena o ka hiamoe kakahiaka. ʻO kēia ʻaoʻao, a me ka blockade like o nā ʻae ʻelua o ka orexin - hiki ke alakaʻi i ka pale ʻana i ke ʻano o ka hyperactivity sympathetic maʻi o ka insomnia - hiki ke wehewehe i ka hoʻomaikaʻi ʻana a mākou e ʻike nei i ka hana ʻana i ke ao me 50 mg o daridorexant.

ʻO Daridorexant i ka insomnia

Hōʻike ʻia ka maʻi insomnia e ka paʻakikī i ka hoʻomaka ʻana a i ʻole ka mālama ʻana i ka hiamoe a pili pū me ka pilikia a i ʻole ka hōʻino ʻana i ka hana ʻana i ke ao. Ua hōʻike ʻia e ka poʻe me ka insomnia ka nui o nā hoʻopiʻi o ke ao, mai ka luhi a me ka emi ʻana o ka ikehu i ka hoʻololi ʻana o ke ʻano a me nā pilikia noʻonoʻo.

Hoʻopili ʻia ka insomnia me kahi ʻōnaehana hoʻāla nui.

Ua hoʻolālā ʻia a hoʻomohala ʻia ʻo Daridorexant, kahi ʻano antagonist receptor dual orexin receptor, e Idorsia no ka mālama ʻana i ka insomnia. Manaʻo ʻo Daridorexant i ke ʻano o ka wakefulness nui o ka insomnia ma ke kāohi ʻana i ka hana o orexin. ʻO Daridorexant ke kuhikuhi pono nei i ka ʻōnaehana orexin ma o ka hoʻokūkū paʻa ʻana me nā mea loaʻa ʻelua, a laila hoʻohuli hou i ka hana o ka orexin.

ʻO Daridorexant ka FDA i ʻae ʻia ma US ma lalo o ka inoa kālepa QUVIVIQ™ a e loaʻa iā ia ma hope o ka hoʻonohonoho ʻana e ka US Drug Enforcement Administration i Mei 2022.

He aha e lawe ʻia mai kēia ʻatikala:

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).