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Sleep Aids now Must Carry Warnings of Risky Sleep Behaviors

Posted Tuesday, May 21, 2019 by Carl-Erich Kruse

The FDA this week announced that it is requiring certain sleep aids to prominently feature, on their boxes, warnings of risky sleep behaviors such as sleep walking and sleep driving. The warning is meant to warn patients to stop taking the medication if they are finding they are engaging in activities when they are not fully awake. The FDA warning is targeting popular sleep aids Lunesta, Sonata, and Ambien.

The FDA acknowledges that the Boxed Warning is the agency’s most prominent warning, and the Contraindication is the agency’s strongest warning, to avoid use in patients with prior episodes of complex sleep behavior. These behaviors can lead to injuries and death of either the patient or victim of the half-asleep, unaware patient. The warnings are meant to inform both patients and health care professionals.

The drugs have been on the market to treat insomnia or many years. Injuries from complex sleep behaviors are rare, but can be significant and devastating, hence the warnings. These warnings are in addition to previous ones that the medication can impair driving and activities that require alertness the morning after use. Drowsiness has already been listed as a possible side effect.

You can read the FDA press release here

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