What You Should Know About Sleeping Pill Side Effects

New FDA warning for common sleep aids

Sleep medication and glass of water with sleeping woman in background

For people who have a hard time getting their ZZZs, medications for insomnia are a dream come true — quite literally.

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But recently, the U.S. Food and Drug Administration announced a new warning about certain prescription medications for insomnia. Sleep medicine specialist Harneet Walia, MD, explains what this warning means for people with insomnia who count on these sleep aids.

Black box warning for sleep aids

Millions of Americans experience insomnia, and many rely on prescription medicines to help them fall asleep and stay asleep.

Now, the FDA will require certain prescription sleep aids to include a black box warning on their labels. It calls attention to serious — even life-threatening — risks.

The new FDA warning applies to three prescription drugs:

  • Eszopiclone (Lunesta®).
  • Zaleplon (Sonata®).
  • Zolpidem (Ambien®, Ambien CR®, Edluar®, Intermezzo® and ZolpiMist ®).

These medications can cause rare but serious incidents known as “complex sleep behaviors,” the FDA says. Those include sleepwalking as well as engaging in other activities while not completely awake — including potentially dangerous ones like using the stove or driving a car.

The FDA required the new warning after reviewing reports of serious events that occurred when people used the medications, including deaths due to car crashes and drowning.

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While these incidents are rare, they could happen whether you’re taking the medication for the first time or have been using it for months.

“Be aware of these warnings so you can watch for any side effects,” Dr. Walia says.

When to stop taking prescription sleep aids

In addition to the new warning, Dr. Walia says the FDA also added a “contraindication” for these medications: Anyone who has experienced complex sleep behaviors — even once — should stop using the drugs.

How will you know if you’re up and about while you’re, you know, asleep? If you have a bed partner, he or she will probably notice you get up and move around. You might also see evidence of nighttime activity, like bowls from a mysterious midnight snack left on the counter. “Usually, there are clues,” Dr. Walia says.

Cognitive behavioral therapy for insomnia

What happens if you have insomnia and have to (or want to) stop taking these medications? You don’t have to give up on the dream of a restful night.

Non-drug alternatives do exist — and may even be preferable to drugs, Dr. Walia adds. She recommends patients try these first and use medications as a last resort.

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“Cognitive behavioral therapy (called CBT-I) for insomnia is the gold standard treatment,” she says.

“It’s safe, effective and has no side effects, and once you learn good sleep habits, the effects are long-lasting.”

Don’t let insomnia go untreated

For people who don’t have success with CBT-I, insomnia medications can still be a safe option, Dr. Walia says. But talk to your healthcare provider to understand the risks and discuss the pros and cons.

Whatever you and your doctor decide, it’s important to address insomnia head-on. In the short term, insomnia can cause excessive daytime sleepiness, trouble with attention and concentration, and drowsy driving. Long term, it can cause health problems like an increased risk of high blood pressure and diabetes. “Insomnia has wide-reaching consequences,” Dr. Walia says. “Sleep is crucial for well-being.”

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