The US black box warns of the risk of serious injury from certain complex sleep behaviors of insomnia drugs

On April 30, 2019, the US Food and Drug Administration (FDA) released a report that certain common treatments for insomnia are due to complex sleep behaviors (including sleepwalking, sleep driving, and other activities that are not fully awake). A rare but serious injury or even death has occurred. These behaviors appear to be more common in eszopiclone, zaleplon, and zolpidem than other prescription drugs used to treat insomnia. Therefore, the FDA requires black box warnings in these drug instructions and patient medication guidelines, as well as requiring patients who have previously experienced abnormal sleep behavior with eszopiclone, zaleplon, and zolpidem as taboos. .

Eszopiclone, zaleplon, and zolpidem are sedative and hypnotic drugs used to treat adult sleep disorders and have been approved for many years. Severe injuries and deaths caused by complex sleep behavior occur in patients with or without such a history of behavior, whether using the lowest recommended dose or a single dose, with or without alcohol or other central nervous system inhibitors (eg sedatives, opioids) Abnormal sleep behavior may occur with these drugs, such as drugs, and anti-anxiety drugs.

For medical staff information:

Patients with complex sleep behavior after taking eszopiclone, zaleplon, and zolpidem should avoid these drugs; if patients have complicated sleep behavior, they should stop using these drugs because of these drugs. Although rare, it has caused serious injury or death.
For patient information:

If the patient is not fully awake after taking the medicine, or if you do not remember the activities you have done, you may have complicated sleep behavior. Stop using the medicine for insomnia and seek medical advice immediately.

Over the past 26 years, the FDA has reported 66 cases of drugs that cause complex sleep behaviors, which are only from the FDA’s Adverse Event Reporting System (FEARS) or medical literature, so there may be more undiscovered cases. 66 cases included accidental overdose, falls, burns, drowning, exposure to limb function at extremely low temperatures, carbon monoxide poisoning, drowning, hypothermia, motor vehicle collisions, and self-injury (eg gunshot wounds and apparent suicide) attempt). Patients usually do not remember these events. The underlying mechanisms by which these insomnia drugs cause complex sleep behavior are currently unclear.

The FDA also reminded the public that all drugs used to treat insomnia will affect the next morning driving and other activities that require vigilance. Drowsiness has been listed as a common side effect on drug labels for all insomnia drugs. The FDA warns patients that they will still feel drowsy the next day after taking these products. Patients who take insomnia medications may experience a decrease in mental alertness even if they feel completely awake the next morning after use.

Additional information for the patient

• Eszopicone, Zaleplon, Zolpidem can cause complex sleep behaviors, including sleepwalking, sleep driving, and other activities without being fully awake. These complex sleep behaviors are rare but have caused serious injury and death.

• These events can occur with just one dose of these drugs or after a longer treatment period.

• If the patient has complicated sleep behavior, stop taking it immediately and seek medical advice promptly.

• Take medication as directed by your doctor. In order to reduce the occurrence of adverse events, do not overdosage, overdose medication.

• Do not take eszopiclone, zaleplon or zolpidem if you cannot guarantee adequate sleep after taking the medicine. If you get too fast after taking the medicine, you may feel drowsy and have problems with memory, alertness or coordination.

Use eszopiclone, zolpidem (flakes, sustained release tablets, sublingual tablets or oral sprays), should go to bed immediately after taking the drug, and stay in bed for 7 to 8 hours.

Use zaleplon tablets or low-dose zolpidem sublingual tablets, should be taken in bed, and at least 4 hours in bed.

• When taking eszopiclone, zaleplon, and zolpidem, do not use any other medications that help you sleep, including some over-the-counter medications. Do not drink alcohol before taking these medicines as it increases the risk of side effects and adverse reactions.

Additional information for medical staff

• Eszopiclone, Zaleplon, and Zolpidem have been reported to cause complex sleep behavior. Complex sleep behavior refers to a patient’s activity without being fully awake, which can lead to serious injury and death.

• These events can occur with just one dose of these drugs or after a longer treatment period.

• Patients who have previously experienced complex sleep behavior with eszopiclone, zaleplon, and zolpidem are prohibited from prescribing these drugs.

• Inform patients to stop using insomnia medications if they have experienced complex sleep behaviors, even if they do not cause serious injury.

• When prescribing eszopiclone, zaleplon or zolpidem to a patient, follow the dosage recommendations in the instructions, starting with the lowest possible effective dose.

• Encourage patients to read drug guidelines when using eszopiclone, zaleplon or zolpidem, and remind them not to use other insomnia medications, alcohol or central nervous system inhibitors.

(FDA website)


Post time: Aug-13-2019
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