We identified 66 cases of complex sleep behaviors occurring with these medicines over the past 26 years that resulted in serious injuries, including death (see Data Summary). Patients should stop taking your insomnia medicine and contact your health care professional right away if you 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. Tell the patient to discontinue taking these medicines if they experience an episode of complex sleep behavior. Advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death. Health care professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Quality sleep can have a positive impact on physical and mental health. These insomnia medicines work by slowing activity in the brain to allow sleep. They are in a class of medicines called sedative-hypnotics and have been approved and on the market for many years. These behaviors can occur after taking these medicines with or without alcohol or other central nervous system depressants that may be sedating such as tranquilizers, opioids, and anti-anxiety medicines.Įszopiclone, zaleplon, and zolpidem are medicines used to treat insomnia in adults who have difficulty falling asleep or staying asleep. Serious injuries and death from complex sleep behaviors have occurred in patients with and without a history of such behaviors, even at the lowest recommended doses, and the behaviors can occur after just one dose. We are also requiring a Contraindication, our strongest warning, to avoid use in patients who have previously experienced an episode of complex sleep behavior with eszopiclone, zaleplon, and zolpidem. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than other prescription medicines used for sleep.Īs a result, we are requiring information about this risk to be added to the Boxed Warning, our most prominent warning, of the prescribing information and to the patient Medication Guides for these medicines. These complex sleep behaviors have also resulted in deaths. What is depression? A Mayo Clinic expert explains.The Food and Drug Administration (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.Depression and anxiety: Can I have both?.CPAP machines: Tips for avoiding 10 common problems.Clinical depression: What does that mean?.Antidepressants: Which cause the fewest sexual side effects?.Antidepressants: Selecting one that's right for you.Antidepressants: Can they stop working?.Antidepressants and weight gain: What causes it?.Antidepressants and alcohol: What's the concern?.Antidepressant withdrawal: Is there such a thing?.FDA drug safety communication: FDA approves new label changes and dosing for zolpidem products and a recommendation to avoid driving the day after using Ambien CR.Clinical practice guideline for the pharmacologic treatment of chronic insomnia in adults: An American Academy of Sleep Medicine clinical practice guideline. Pharmacologic treatment of insomnia disorder: An evidence report for a clinical practice guideline by the American College of Physicians. Other therapies include learning new sleep habits (such as keeping your bedtime and wake time consistent from day to day), getting counseling for anxiety or other psychological concerns, and using stress-reduction techniques. The best approach is to address whatever is causing your sleep problems in the first place. For example, medications can mask an underlying problem that needs treatment. Sleep medications can be useful in the short term, but relying on them usually isn't the best long-term solution for insomnia. In rare cases, these sleep medications may trigger a life-threatening allergic reaction (anaphylaxis). Because you're not awake, these are dangerous behaviors.Īlso, the Food and Drug Administration recommends that you avoid driving or doing activities that require full mental alertness the next day, as you may still have some impairment from the sleep medication, especially if you take extended-release drugs. For example, some people who take zolpidem or similar medications, such as eszopiclone (Lunesta), do things while asleep that they don't remember - such as driving, or preparing and eating food. But there can be concerning side effects.
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