Ngomhla zingama-30 kuMbasa, 2019, i-US Food and Drug Administration (FDA) ikhiphe umbiko wokuthi ezinye izindlela zokwelapha ezivamile zokuqwasha zibangelwa ukuziphatha okuyinkimbinkimbi kokulala (okuhlanganisa nokulala, ukushayela ulele, neminye imisebenzi engavuki ngokugcwele).Ukulimala okungajwayelekile kodwa okubi kakhulu noma ngisho nokufa.Lokhu kuziphatha kubonakala kuvame kakhulu ku-eszopiclone, zaleplon, ne-zolpidem kunezinye izidakamizwa zikadokotela ezisetshenziselwa ukwelapha ukuqwasha.Ngakho-ke, i-FDA idinga izixwayiso zebhokisi elimnyama kule miyalo yezidakamizwa kanye neziqondiso zemithi yesiguli, kanye nokudinga iziguli eziye zabhekana nokuziphatha okungavamile kokulala nge-eszopiclone, zaleplon, ne-zolpidem njengama-taboos..
I-Eszopiclone, i-zaleplon, ne-zolpidem yizidakamizwa ezilalisa umzimba kanye ne-hypnotic ezisetshenziselwa ukwelapha ukuphazamiseka kokulala kwabantu abadala futhi sezivunyelwe iminyaka eminingi.Ukulimala okubi kakhulu nokufa okubangelwa ukuziphatha okuyinkimbinkimbi kokulala kwenzeka ezigulini ezinomlando wokuziphatha noma ongenawo, kungakhathaliseki ukuthi zisebenzisa umthamo ophansi onconywayo noma umthamo owodwa, ezinotshwala noma ngaphandle kwazo noma ezinye izithiyo zesistimu yezinzwa emaphakathi (isb. ama-sedative, ama-opioid) Ukulala okungajwayelekile. ukuziphatha kungase kwenzeke ngale mithi, njengezidakamizwa, nezidakamizwa ezilwa nokukhathazeka.
Ngolwazi lwabasebenzi bezokwelapha:
Iziguli ezinokuziphatha okuyinkimbinkimbi kokulala ngemva kokuthatha i-eszopiclone, i-zaleplon, ne-zolpidem kufanele zigweme lezi zidakamizwa;uma iziguli zinokuziphatha okuyinkimbinkimbi kokulala, kufanele ziyeke ukusebenzisa le mithi ngenxa yale mithi.Nakuba kungavamile, kuye kwabangela ukulimala okubi kakhulu noma ukufa.
Ukuze uthole ulwazi lwesiguli:
Uma isiguli singakaphaphami ngokugcwele ngemva kokuphuza umuthi, noma uma ungakhumbuli imisebenzi oyenzile, ungase ube nokuziphatha okuyinkimbinkimbi kokulala.Yeka ukusebenzisa umuthi wokuqwasha futhi ufune izeluleko zezokwelapha ngokushesha.
Eminyakeni engu-26 edlule, i-FDA ibike izehlakalo ezingu-66 zezidakamizwa ezibangela ukuziphatha okuyinkimbinkimbi kokulala, okuvela kuphela ohlelweni Lokubika Izenzakalo Ezibi ye-FDA (UKWESABA) noma izincwadi zezokwelapha, ngakho kungase kube nezinye izimo ezingakatholwa.Amacala angu-66 ahlanganisa ukweqisa kwezidakamizwa ngengozi, ukuwa, ukusha, ukuminza, ukuchayeka ekusebenzeni kwezitho zomzimba emazingeni okushisa aphansi kakhulu, ubuthi be-carbon monoxide, ukuminza, i-hypothermia, ukushayisana kwezimoto, nokuzilimaza (isb. amanxeba okudutshulwa kanye nokuzama ukuzibulala).Iziguli ngokuvamile azikhumbuli lezi zenzakalo.Izindlela eziyisisekelo lapho le mithi yokuqwasha idala ukuziphatha okuyinkimbinkimbi kokulala okwamanje azikacaci.
I-FDA iphinde yakhumbuza umphakathi ukuthi zonke izidakamizwa ezisetshenziselwa ukwelapha ukuqwasha zizophazamisa ukushayela ngakusasa ekuseni kanye neminye imisebenzi edinga ukuqapha.Ukozela kufakwe ohlwini njengomthelela oseceleni ovamile kumalebula ezidakamizwa azo zonke izidakamizwa zokuqwasha.I-FDA ixwayisa iziguli ukuthi zisazozizwa ziyozela ngakusasa ngemva kokuthatha le mikhiqizo.Iziguli ezithatha imishanguzo yokuqwasha zingase zibe nokuncipha kokuphaphama kwengqondo ngisho noma zizwa siphapheme ngokuphelele ngakusasa ekuseni ngemva kokusetshenziswa.
Ulwazi olwengeziwe lwesiguli
• I-Eszopicone, i-Zaleplon, i-Zolpidem ingabangela ukuziphatha okuyinkimbinkimbi kokulala, kuhlanganise nokulala, ukushayela ukulala, neminye imisebenzi ngaphandle kokuphaphama ngokugcwele.Lezi zindlela zokuziphatha eziyinkimbinkimbi zokulala azivamile kodwa zibangele ukulimala okubi kakhulu nokufa.
• Lezi zehlakalo zingenzeka ngomthamo owodwa nje wale mithi noma ngemva kwesikhathi eside sokwelashwa.
• Uma isiguli sinokuziphatha okuyinkimbinkimbi kokulala, yeka ngokushesha futhi ufune iseluleko sezokwelapha ngokushesha.
• Thatha imithi njengoba uyalelwe udokotela wakho.Ukuze unciphise ukwenzeka kwezenzakalo ezimbi, musa ukweqisa izidakamizwa, ukweqisa izidakamizwa.
• Ungathathi i-eszopiclone, i-zaleplon noma i-zolpidem uma ungeke ukwazi ukuqinisekisa ukulala ngokwanele ngemva kokuphuza umuthi.Uma ushesha kakhulu ngemva kokuphuza umuthi, ungase uzizwe usozela futhi ube nenkinga yenkumbulo, ukuphaphama noma ukusebenzisana.
Sebenzisa i-eszopiclone, i-zolpidem (ama-flakes, amaphilisi okukhululwa okuqhubekayo, amaphilisi angama-sublingual noma izifutho zomlomo), kufanele ulale ngokushesha ngemva kokuphuza umuthi, futhi uhlale embhedeni amahora angu-7 kuya kwangu-8.
Sebenzisa amaphilisi e-Zaleplon noma amaphilisi e-zolpidem sublingual anedosi ephansi, kufanele aphuzwe embhedeni, futhi okungenani amahora angu-4 embhedeni.
• Uma uthatha i-eszopiclone, i-zaleplon, ne-zolpidem, ungasebenzisi noma yimiphi eminye imithi ekusiza ukuthi ulale, kuhlanganise nemithi etholakala ngaphandle kwe-counter.Ungaphuzi utshwala ngaphambi kokuthatha le mithi njengoba kwandisa ingozi yemiphumela emibi kanye nokusabela okubi.
Ulwazi olwengeziwe lwabasebenzi bezokwelapha
• I-Eszopiclone, i-Zaleplon, ne-Zolpidem kubikwe ukuthi ibangela ukuziphatha kokulala okuyinkimbinkimbi.Ukuziphatha okuyinkimbinkimbi kokulala kubhekisela emsebenzini wesiguli ngaphandle kokuphaphama ngokugcwele, okungaholela ekulimaleni okubi kakhulu nokufa.
• Lezi zehlakalo zingenzeka ngomthamo owodwa nje wale mithi noma ngemva kwesikhathi eside sokwelashwa.
• Iziguli ezike zabhekana nokuziphatha okuyinkimbinkimbi kokulala nge-eszopiclone, i-zaleplon, ne-zolpidem azivunyelwe ekunikezeni le mithi.
• Yazisa iziguli ukuthi ziyeke ukusebenzisa imithi yokuqwasha uma ziye zabhekana nokuziphatha okuyinkimbinkimbi kokulala, ngisho noma zingabangeli ukulimala okubi kakhulu.
• Uma ubeka i-eszopiclone, i-zaleplon noma i-zolpidem esigulini, landela izincomo zomthamo emiyalweni, uqale ngesilinganiso esiphansi kakhulu esisebenzayo.
• Khuthaza iziguli ukuthi zifunde iziqondiso zezidakamizwa lapho zisebenzisa i-eszopiclone, i-zaleplon noma i-zolpidem, futhi uzikhumbuze ukuthi zingasebenzisi eminye imithi yokuqwasha, utshwala noma i-central nervous system inhibitors.
(Iwebhusayithi ye-FDA)
Isikhathi sokuthumela: Aug-13-2019