Black box warning on sleeping pills

Black box warning on sleeping pills

Sleepwalking down stairs

The FDA has a new black box warning on sleeping pills (zolpidem or AmbienR, eszopiclone or LunestaR, and zaleplon or SonataR). These can cause unusual behavior in sleep (parasomnias). Patients report walking in their sleep or eating in their sleep. This happens often enough. Rarely, patients may fall, are burned, or almost drown. They may overdose or expose themselves to extreme cold with frostbite. They may even accidentally shoot themselves or attempt suicide. Patients have died of carbon monoxide poisoning, drowning, falls, motor vehicle accidents while drowning, exposure to extreme cold, or suicide.

Physicians should not prescribe these medicines to patients with history of complex sleep behavior after taking these medicines. They should advise patients what rare but serious injuries and death may occur with these medicines.

These medicines work on the benzodiazepine receptor in the brain. There are older medicines that also work on the same receptor. The older medicines also reduced anxiety. These medicines may not reduce anxiety.

Sleeping pills should not be taken for more than a few weeks. They are generally addicting, and their effect diminishes over time. Stopping them may produce withdrawal effects with worse sleep. They are fine for acute insomnia or for occasional insomnia. They are not a good idea for chronic insomnia.

Chronic insomnia often gets better with cognitive behavioral therapy (CBT) and decreasing time in bed. Although a large number of Americans do not get enough time in bed, many others get too much time in bed. As a result, they do not sleep well.

Other medicines for insomnia

There are FDA approved sleeping pills that do not work on the benzodiazepine receptor. However, medicines working on melatonin (ramelteon or RozeremR ) and orexin (suvorexant or BelsomraR ) receptors have generally not proved very effective in clinical practice. When medicines are necessary for chronic insomnia, there are off-label medicines (such as trazodone) which are quite effective and non-addicting.

In conclusion, the FDA black box warning on zolpidem, eszopiclone and zaleplon is one more reason to avoid taking these medicines long-term.

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