Certain Prescription Insomnia Medicines: New Boxed Warning - Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: FDA is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with
• Lunesta (eszopiclone)
• onata (zaleplon)
• Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem)
than other prescription medicines used for sleep.
BACKGROUND: Eszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These insomnia medicines work by slowing activity in the brain to allow sleep. Quality sleep can have a positive impact on physical and mental health.
RECOMMENDATION:
If patients experience a complex sleep behavior where you engage in activities while you are not fully awake or if you do not remember activities you have done while taking the medicine you should:
• Stop taking your insomnia medicine.
• Contact your health care professional right away if you.
Healthcare professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Healthcare Professionals should advise all patients that:
• Although rare, the behaviors caused by these medicines have led to serious injuries or death.
• To discontinue taking these medicines if they experience an episode of complex sleep behavior.
Read the MedWatch Safety Alert, including a link to the FDA Drug Safety Communication, at:
https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/certain-prescription-insomnia-medicines-new-boxed-warning-due-risk-serious-injuries-caused
美國FDA發布藥物安全警訊，某些常見的處方失眠藥物，因為睡眠行為，包括夢遊(sleepwalking)、睡眠開車(sleep driving)及在未完全清醒的情況下從事其他活動，而發生罕見但嚴重的傷害，這些複雜的睡眠行為也曾導致死亡。與其他常見失眠藥物相比，以下這些藥品較常出現此種睡眠行為：eszopiclone、zaleplon、zolpidem。
Eszopiclone、zaleplon、zolpidem是用於治療難以入睡或維持睡眠的成人失眠藥物。它們屬於鎮靜安眠藥物，並已於市面上核可使用多年。這些失眠藥物通過減緩大腦活動來幫助睡眠，有品質的睡眠亦可以對身心健康產生正面影響。
如果病人在沒有完全清醒的情況下出現複雜的睡眠行為，或者病人不記得在服用藥物時所做的行為，建議病人應該：
• 停止服用失眠藥物。
• 立即聯繫醫療專業人員。
醫療專業人員不應該開立eszopiclone、zaleplon或zolpidem於曾因服用這類藥物而出現複雜睡眠行為的病人。醫療專業人員應提醒所有病人：
• 雖然罕見，但這類藥物所引起的複雜行為曾導致嚴重傷害或死亡。
• 若出現複雜的睡眠行為，請停止服用這類藥物。
相關訊息與連結請參考FDA網址：
https://www.fda.gov/safety/medwatch-safety-alerts-human-medical-products/certain-prescription-insomnia-medicines-new-boxed-warning-due-risk-serious-injuries-caused
[Posted 04/30/2019]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
回首頁 |