FDA News

FDA announces new warning for certain prescription insomnia medicines

On April 30, the FDA announced that rare but serious injuries have occurred while taking certain prescription insomnia medications due to sleep behaviors such as sleep walking, sleep driving and engaging in other activities while not fully awake. Death has also occurred as a result of these complex sleep behaviors.

The reported behaviors are most common with Lunesta (eszopiclone), Sonata (zaleplon) and Ambien, Ambien CR, Edluar and Zolpimist (zolpidem).

The FDA advised that patients stop taking their insomnia medicine and contact their health care professional immediately if they experience complex sleep behaviors that cause them to engage in activities while not being fully awake or if they do not remember things they did while taking the medicine.

Health care professionals are advised not to prescribe eszopiclone, zaleplon or zolpidem to patients who have experienced complex sleep behaviors while taking any of the medicines. They are also asked to advise patients that although the behaviors caused by these medicines are rare, they have led to serious injuries and death. They should also advise patients to stop taking the medicines if they have an episode of complex sleep behavior.

The FDA encourages health care professionals and patients to report any adverse effects of side effects related to using eszopiclone, zaleplon or zolpidem to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submitting a report online or by downloading and submitting a form.

On April 30, the FDA announced that rare but serious injuries have occurred while taking certain prescription insomnia medications due to sleep behaviors such as sleep walking, sleep driving and engaging in other activities while not fully awake. Death has also occurred as a result of these complex sleep behaviors.

The reported behaviors are most common with Lunesta (eszopiclone), Sonata (zaleplon) and Ambien, Ambien CR, Edluar and Zolpimist (zolpidem).

The FDA advised that patients stop taking their insomnia medicine and contact their health care professional immediately if they experience complex sleep behaviors that cause them to engage in activities while not being fully awake or if they do not remember things they did while taking the medicine.

Health care professionals are advised not to prescribe eszopiclone, zaleplon or zolpidem to patients who have experienced complex sleep behaviors while taking any of the medicines. They are also asked to advise patients that although the behaviors caused by these medicines are rare, they have led to serious injuries and death. They should also advise patients to stop taking the medicines if they have an episode of complex sleep behavior.

The FDA encourages health care professionals and patients to report any adverse effects of side effects related to using eszopiclone, zaleplon or zolpidem to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by submitting a report online or by downloading and submitting a form.