Thaum Lub Plaub Hlis 30, 2019, US Food and Drug Administration (FDA) tau tshaj tawm tsab ntawv ceeb toom tias qee yam kev kho mob rau kev pw tsaug zog yog vim muaj kev pw tsaug zog nyuaj (xws li taug kev pw tsaug zog, tsaug zog tsav tsheb, thiab lwm yam dej num uas tsis tsaug zog).Tsis tshua muaj tab sis raug mob hnyav lossis tuag taus tshwm sim.Cov cwj pwm no tshwm sim ntau dua hauv eszopiclone, zaleplon, thiab zolpidem dua li lwm cov tshuaj siv los kho insomnia.Yog li ntawd, FDA xav kom lub thawv dub ceeb toom hauv cov lus qhia tshuaj no thiab cov lus qhia tshuaj rau cov neeg mob, nrog rau xav kom cov neeg mob uas yav dhau los tau ntsib kev pw tsaug zog tsis zoo nrog eszopiclone, zaleplon, thiab zolpidem raws li kev txwv..
Eszopiclone, zaleplon, thiab zolpidem yog cov tshuaj sedative thiab hypnotic siv los kho cov neeg laus pw tsaug zog thiab tau pom zoo rau ntau xyoo.Kev raug mob hnyav thiab kev tuag tshwm sim los ntawm kev pw tsaug zog tsis zoo tshwm sim hauv cov neeg mob uas muaj lossis tsis muaj keeb kwm ntawm tus cwj pwm, txawm tias siv cov koob tshuaj qis tshaj plaws lossis ib koob tshuaj, nrog lossis tsis muaj cawv lossis lwm yam hauv nruab nrab paj hlwb inhibitors (xws li sedatives, opioids) pw tsaug zog tsis zoo. kev coj cwj pwm tuaj yeem tshwm sim nrog cov tshuaj no, xws li tshuaj, thiab tshuaj tiv thaiv kev ntxhov siab.
Rau cov neeg ua haujlwm kho mob cov ntaub ntawv:
Cov neeg mob uas muaj tus cwj pwm pw tsaug zog tom qab noj eszopiclone, zaleplon, thiab zolpidem yuav tsum zam cov tshuaj no;yog tias cov neeg mob muaj tus cwj pwm pw tsaug zog nyuaj, lawv yuav tsum tsis txhob siv cov tshuaj no vim yog cov tshuaj no.Txawm tias tsis tshua muaj, nws tau ua rau raug mob hnyav lossis tuag.
Rau cov ntaub ntawv tus neeg mob:
Yog tias tus neeg mob tsis tsaug zog tag nrho tom qab noj cov tshuaj, lossis yog tias koj tsis nco qab txog cov dej num koj tau ua, koj yuav muaj teeb meem pw tsaug zog.Txhob siv tshuaj rau insomnia thiab nrhiav kev kho mob tam sim ntawd.
Tshaj li 26 xyoo dhau los, FDA tau tshaj tawm txog 66 qhov xwm txheej ntawm cov tshuaj uas ua rau kev pw tsaug zog tsis yooj yim, uas tsuas yog los ntawm FDA's Adverse Event Reporting System (FEARS) lossis cov ntaub ntawv kho mob, yog li tej zaum yuav muaj ntau qhov tsis pom.66 qhov xwm txheej suav nrog kev siv tshuaj ntau dhau, ntog, kub hnyiab, poob dej, raug rau cov ceg tawv ntawm qhov kub tsis tshua muaj siab, muaj pa roj carbon monoxide lom, poob dej, hypothermia, kev sib tsoo ntawm lub tsheb, thiab kev raug mob rau tus kheej (xws li phom phom thiab kev sim tua tus kheej).Cov neeg mob feem ntau tsis nco qab cov xwm txheej no.Cov txheej txheem hauv qab uas cov tshuaj insomnia no ua rau kev pw tsaug zog tsis meej tam sim no.
FDA kuj tau ceeb toom rau pej xeem tias txhua yam tshuaj siv los kho insomnia yuav cuam tshuam rau yav sawv ntxov kev tsav tsheb thiab lwm yam dej num uas yuav tsum tau ceev faj.Drowsiness tau teev tseg raws li ib qho kev mob tshwm sim ntawm cov npe tshuaj rau tag nrho cov tshuaj insomnia.FDA ceeb toom cov neeg mob tias lawv tseem yuav tsaug zog rau hnub tom qab tom qab noj cov khoom no.Cov neeg mob uas noj cov tshuaj insomnia tuaj yeem ua rau muaj kev ntxhov siab ntawm kev puas siab puas ntsws txawm tias lawv xav tias tsaug zog tag kis tom qab siv.
Cov ntaub ntawv ntxiv rau tus neeg mob
• Eszopicone, Zaleplon, Zolpidem tuaj yeem ua rau muaj kev pw tsaug zog tsis yooj yim, suav nrog kev pw tsaug zog, pw tsaug zog, thiab lwm yam dej num uas tsis tas yuav tsaug zog.Cov cwj pwm pw tsaug zog nyuaj no tsis tshua muaj tab sis tau ua rau raug mob hnyav thiab tuag.
• Cov xwm txheej no tuaj yeem tshwm sim tsuas yog ib koob ntawm cov tshuaj no lossis tom qab lub sijhawm kho mob ntev dua.
• Yog tias tus neeg mob muaj tus cwj pwm pw tsaug zog nyuaj, tsis txhob noj tam sim ntawd thiab nrhiav kev kho mob tam sim ntawd.
• Noj tshuaj raws li koj tus kws kho mob qhia.Txhawm rau txo qhov tshwm sim ntawm qhov tshwm sim tsis zoo, tsis txhob noj ntau dhau, noj tshuaj ntau dhau.
• Tsis txhob noj eszopiclone, zaleplon lossis zolpidem yog tias koj tsis tuaj yeem lav qhov pw tsaug zog txaus tom qab noj cov tshuaj.Yog tias koj tau txais sai heev tom qab noj cov tshuaj, koj yuav xav tias tsaug zog thiab muaj teeb meem nrog kev nco, kev ceeb toom lossis kev sib koom tes.
Siv eszopiclone, zolpidem (flakes, sustained release tablets, sublingual tablets or oral sprays), yuav tsum mus pw tam sim ntawd tom qab noj cov tshuaj, thiab nyob twj ywm hauv txaj rau 7 mus rau 8 teev.
Siv cov ntsiav tshuaj zaleplon lossis cov ntsiav tshuaj zolpidem qis qis, yuav tsum tau noj hauv txaj, thiab tsawg kawg 4 teev hauv txaj.
• Thaum noj eszopiclone, zaleplon, thiab zolpidem, tsis txhob siv lwm yam tshuaj uas pab koj tsaug zog, suav nrog qee cov tshuaj tom khw muag khoom.Tsis txhob haus cawv ua ntej noj cov tshuaj no vim nws ua rau muaj kev pheej hmoo ntawm kev mob tshwm sim thiab kev tsis zoo.
Cov ntaub ntawv ntxiv rau cov neeg ua haujlwm kho mob
• Eszopiclone, Zaleplon, thiab Zolpidem tau raug tshaj tawm tias ua rau muaj kev pw tsaug zog nyuaj.Tus cwj pwm pw tsaug zog nyuaj yog hais txog tus neeg mob txoj haujlwm yam tsis tau tsaug zog, uas tuaj yeem ua rau raug mob hnyav thiab tuag.
• Cov xwm txheej no tuaj yeem tshwm sim tsuas yog ib koob ntawm cov tshuaj no lossis tom qab lub sijhawm kho mob ntev dua.
• Cov neeg mob uas yav tas los tau ntsib kev pw tsaug zog nyuaj nrog eszopiclone, zaleplon, thiab zolpidem raug txwv tsis pub sau cov tshuaj no.
• Qhia rau cov neeg mob kom tsis txhob siv tshuaj insomnia yog tias lawv tau ntsib kev pw tsaug zog nyuaj, txawm tias lawv tsis ua rau raug mob hnyav.
• Thaum muab tshuaj eszopiclone, zaleplon lossis zolpidem rau tus neeg mob, ua raws li cov lus pom zoo noj hauv cov lus qhia, pib nrog qhov qis tshaj qhov ua tau zoo.
• Txhawb cov neeg mob kom nyeem cov lus qhia txog tshuaj thaum siv eszopiclone, zaleplon lossis zolpidem, thiab ceeb toom lawv kom tsis txhob siv lwm yam tshuaj insomnia, cawv los yog central nervous system inhibitors.
(FDA website)
Post lub sij hawm: Aug-13-2019