Nge-30 ka-Epreli ka-2019, i-US Food and Drug Administration (FDA) yakhupha ingxelo yokuba unyango oluthile oluqhelekileyo lokuphuthelwa lubangelwa kukuziphatha okuntsokothileyo kokulala (kubandakanya ukulala, ukuqhuba ukulala, kunye nezinye izinto ezingavukanga ngokupheleleyo).Ukwenzakala okunqabileyo kodwa okumandundu okanye nokufa kuye kwenzeka.Ezi ziphatha zibonakala zixhaphake kakhulu kwi-eszopiclone, zaleplon, kunye ne-zolpidem kunamanye amayeza amayeza asetyenziselwa ukunyanga ukulala.Ngoko ke, i-FDA idinga izilumkiso zebhokisi ezimnyama kule miyalelo yeyeza kunye nezikhokelo zamayeza esigulane, kunye nokufuna izigulane eziye zafumana ukuziphatha okungaqhelekanga kokulala kunye ne-eszopiclone, zaleplon, kunye ne-zolpidem njenge-taboos..
I-Eszopiclone, i-zaleplon, kunye ne-zolpidem ziziyobisi zokuthoba kunye ne-hypnotic ezisetyenziselwa ukuphatha ukuphazamiseka kokulala kwabantu abadala kwaye zivunyiwe iminyaka emininzi.Ukwenzakala okumandundu kunye nokufa okubangelwa kukuziphatha okuntsokothileyo kokulala kwenzeka kwizigulana ezinembali enjalo okanye ezingenazo ezo zembali zokuziphatha, nokuba zisebenzisa elona thamo lisezantsi licetyiswayo okanye idosi enye, enotywala okanye ngaphandle kwe-inhibitors ye-nervous system inhibitors (umz. i-sedative, i-opioids) Ukulala ngokungaqhelekanga. ukuziphatha kunokwenzeka ngala machiza, ezifana neziyobisi, kunye neziyobisi anti-ukukhathazeka.
Ngolwazi lwabasebenzi bezonyango:
Izigulane ezinokuziphatha okunzima kokulala emva kokuthatha i-eszopiclone, i-zaleplon, kunye ne-zolpidem kufuneka zigweme ezi ziyobisi;ukuba abaguli banesimilo esinzima sokulala, kufuneka bayeke ukusebenzisa la mayeza ngenxa yala mayeza.Nangona kunqabile, kuye kwabangela ukwenzakala okukhulu okanye ukufa.
Ngolwazi lwesigulana:
Ukuba isigulana asivuki ngokupheleleyo emva kokuthatha iyeza, okanye ukuba awuyikhumbuli imisebenzi oyenzileyo, unokuba nokuziphatha okuntsokothileyo kokulala.Yeka ukusebenzisa iyeza lokuphuthelwa kwaye ufune iingcebiso zonyango ngokukhawuleza.
Kwiminyaka engama-26 edlulileyo, i-FDA iye yabika iimeko ze-66 zeziyobisi ezibangela ukuziphatha okunzima kokulala, okuvela kuphela kwi-FDA's Adverse Event Reporting System (I-FEARS) okanye uncwadi lwezonyango, ngoko ke kunokubakho iimeko ezininzi ezingafunyaniswanga.Iimeko ezingama-66 zibandakanya ukugqithisa ngengozi, ukuwa, ukutshisa, ukurhaxwa, ukuchanabeka ekusebenzeni kwemilenze kumaqondo aphantsi kakhulu, ityhefu ye-carbon monoxide, ukurhaxwa, i-hypothermia, ukungqubana kwemoto, kunye nokuzenzakalisa (umzekelo, amanxeba okudutyulwa kunye nokubonakala kokuzibulala) ukuzama).Izigulane azikhumbuli ezi ziganeko.Iindlela ezisisiseko apho la mayeza okuphuthelwa abangela ukuziphatha okuntsokothileyo kokulala azikacaci okwangoku.
I-FDA iphinde yakhumbuza uluntu ukuba zonke iziyobisi ezisetyenziselwa ukunyanga ukulala ziyakuchaphazela ukuqhuba ngentsasa elandelayo kunye neminye imisebenzi efuna ukuqaphela.Ukozela kudweliswe njengesiphumo esixhaphakileyo kwiilebhile zeziyobisi kuwo onke amayeza okuphuthelwa.I-FDA ilumkisa izigulana ukuba zisezakuziva zozela ngosuku olulandelayo emva kokuthatha ezi mveliso.Izigulana ezithatha amayeza okuphuthelwa zinokuba nengxaki yokuncipha kokuphaphama kwengqondo nokuba ziziva zivukile ngokupheleleyo ngentsasa elandelayo emva kokusetyenziswa.
Ulwazi olongezelelweyo lwesigulane
• I-Eszopicone, i-Zaleplon, i-Zolpidem inokubangela ukuziphatha okunzima kokulala, kubandakanywa nokulala, ukuqhuba ukulala, kunye neminye imisebenzi ngaphandle kokuvuka ngokupheleleyo.Ezi ndlela zokuziphatha zintsokothileyo zokulala zinqabile kodwa ziye zabangela ukwenzakala okukhulu nokufa.
• Ezi ziganeko zingenzeka ngedosi nje enye yala machiza okanye emva kwexesha elide lonyango.
• Ukuba isigulana sinendlela enzima yokulala, yeka ukuyisela ngokukhawuleza kwaye ufune iingcebiso kugqirha ngokukhawuleza.
• Thatha amayeza njengoko uyalelwe ngugqirha wakho.Ukuze kuncitshiswe ukwenzeka kweziganeko ezimbi, musa ukugqithisa, ukugqithisa amayeza.
• Musa ukuthatha i-eszopiclone, i-zaleplon okanye i-zolpidem ukuba awunakuqinisekisa ukulala ngokwaneleyo emva kokuthatha iyeza.Ukuba ukhawuleza kakhulu emva kokuthatha iyeza, unokuziva usozela kwaye ube nengxaki yokukhumbula, ukuphaphama okanye ulungelelwaniso.
Sebenzisa i-eszopiclone, i-zolpidem (ii-flakes, iipilisi zokukhululwa okuqhubekayo, iipilisi ezingaphantsi kweelwimi okanye izitshizi zomlomo), kufuneka ulale ngokukhawuleza emva kokuthatha iyeza, kwaye uhlale ebhedini iiyure ezi-7 ukuya kwezi-8.
Sebenzisa iipilisi ze-zaleplon okanye i-dose ephantsi ye-zolpidem i-sublingual tablets, kufuneka ithathwe ebhedini, kwaye ubuncinane iiyure ze-4 ebhedini.
• Xa uthatha i-eszopiclone, i-zaleplon, kunye ne-zolpidem, ungasebenzisi nawaphi na amayeza akunceda ukuba ulale, kubandakanywa namayeza angaphandle kwe-counter.Musa ukusela utywala phambi kokuba uthathe la mayeza njengoko kwandisa umngcipheko weziphumo ebezingalindelekanga kunye neempendulo ezibi.
Ulwazi olongezelelweyo lwabasebenzi bezonyango
• I-Eszopiclone, i-Zaleplon, kunye ne-Zolpidem ziye zabikwa ukuba zibangele ukuziphatha okuyinkimbinkimbi kokulala.Ukuziphatha okuntsonkothileyo kokulala kubhekisela kumsebenzi wesigulana ngaphandle kokuphaphama ngokupheleleyo, nto leyo enokukhokelela kukwenzakala okukhulu nokufa.
• Ezi ziganeko zingenzeka ngedosi nje enye yala machiza okanye emva kwexesha elide lonyango.
• Izigulane eziye zafumana ukuziphatha okuntsokothileyo kwangaphambili kunye ne-eszopiclone, i-zaleplon, kunye ne-zolpidem akuvumelekanga ukumisela la mayeza.
• Yazisa izigulana ukuba ziyeke ukusebenzisa amayeza okuphuthelwa ukuba ziye zafumana iindlela zokuziphatha ezintsonkothileyo zokulala, nokuba azibangeli konzakala kakhulu.
• Xa uchaza i-eszopiclone, i-zaleplon okanye i-zolpidem kwisigulane, landela iingcebiso ze-dosage kwimiyalelo, ngokuqala ngeyona nto iphantsi yedosi esebenzayo.
• Khuthaza izigulane ukuba zifunde izikhokelo zeziyobisi xa zisebenzisa i-eszopiclone, i-zaleplon okanye i-zolpidem, kwaye zikhumbuze ukuba zingasebenzisi ezinye iyeza zokulala, utywala okanye i-central nervous system inhibitors.
(iwebhusayithi ye-FDA)
Ixesha lokuposa: Aug-13-2019