US Food & Drug Administration (FDA) is advising that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviours, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviours have also resulted in deaths. These behaviours appear to be more common with Z-drugs (zopiclone, zolpidem, zaleplon, eszopiclone) than other prescription medicines used for sleep.
Z-drugs registered by Nigeria’s NAFDAC include Zopiclone (Zopice, Zopimax) and Zolpidem (Stilnox).
Serious injuries and death from complex sleep behaviours have occurred in patients with and without a history of such behaviours, even at the lowest recommended doses, and the behaviours can occur after just one dose. These behaviours can occur after taking these medicines with or without alcohol or other CNS depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.
Z-drugs 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.
Health care professionals should not prescribe zopiclone, zolpidem, zaleplon, or eszopiclone to patients who have previously experienced complex sleep behaviours after taking any of these medicines. Advise all patients that although rare, the behaviours caused by these medicines have led to serious injuries or death. Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behaviour.
Patients should stop taking your insomnia medicine and contact your health care professional right away if you experience a complex sleep behaviour 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
Zopiclone monograph in EMDEX has been updated to reflect this important safety information. See Zopiclone (under Pharmacovigilance, Advice to Patients and Contra-indications).