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What is the biggest side effect of Ambien?

4 min read

In 2019, the FDA added a boxed warning to Ambien (zolpidem) and similar medications due to the risk of complex sleep behaviors. This warning draws attention to what is arguably the biggest side effect of Ambien, which involves users engaging in dangerous activities while not fully awake.

Quick Summary

Complex sleep behaviors, such as sleep-driving and sleepwalking, represent the most serious side effect of Ambien use, carrying a risk of injury or death. Other major risks include next-day impairment, especially for women and older adults, and the potential for dependence.

Key Points

  • Complex Sleep Behaviors: The most serious side effect is performing activities like driving, cooking, or sleepwalking while not fully awake and having no memory of the event afterward.

  • FDA Boxed Warning: The FDA requires Ambien to carry a boxed warning about the risk of serious injury or death from these complex sleep behaviors.

  • Next-Day Impairment: Lingering drowsiness, dizziness, and decreased alertness can significantly impair driving and other activities the following day.

  • Dependence and Withdrawal: Long-term use or misuse can lead to physical dependence, with abrupt cessation causing withdrawal symptoms like insomnia, anxiety, and tremors.

  • Cognitive Effects: Memory impairment, particularly anterograde amnesia (forgetting events after taking the pill), can occur, especially at higher doses.

  • Risk Factors: The risk of serious side effects increases with higher doses, longer use, age (especially older adults), and combining the medication with alcohol or other CNS depressants.

In This Article

Ambien and its potential for serious side effects

Ambien, the brand name for zolpidem, is a sedative-hypnotic medication prescribed for the short-term treatment of insomnia. It works by affecting the brain's gamma-aminobutyric acid (GABA) receptors to slow down activity in the central nervous system, helping a person fall asleep. While effective for many, it carries significant risks, with the most severe being complex sleep behaviors. For this reason, the U.S. Food and Drug Administration (FDA) has required a boxed warning, the most serious type of warning, for this specific side effect.

The most dangerous side effect: Complex sleep behaviors

Complex sleep behaviors refer to a range of unconscious activities performed while a person is not fully awake after taking a sleep medication. These actions are particularly alarming because the user has no memory of the event afterwards (anterograde amnesia). The FDA's boxed warning, updated in 2019, explicitly highlights this risk due to cases resulting in serious injury and even death.

Examples of these dangerous, unremembered behaviors include:

  • Sleep-driving: Operating a vehicle with no recollection of doing so. This can lead to serious accidents and legal consequences.
  • Sleepwalking: Walking, leaving the house, or engaging in other activities while not fully conscious.
  • Sleep-cooking/eating: Preparing and consuming food.
  • Other activities: This can include making phone calls, having sex (sexsomnia), and performing other complex tasks.

If any complex sleep behavior occurs, the medication should be discontinued immediately.

Next-day impairment and daytime drowsiness

While complex sleep behaviors are the most acutely dangerous side effect, next-day impairment and daytime drowsiness are far more common and represent a significant risk. Because zolpidem can remain in the system for hours, users can experience lingering effects the following morning, even after a full night's sleep.

FDA dosing changes

In 2013, the FDA required label changes and lower recommended doses for zolpidem products specifically to address the risk of next-day impairment. This was prompted by evidence showing that drug levels in the bloodstream could be high enough to impair activities requiring full alertness, such as driving. Women, who clear the drug from their systems more slowly than men, were advised to start at a lower dose.

Dependence and withdrawal risk

Despite being less habit-forming than older sedative classes like benzodiazepines, Ambien can lead to physical dependence, particularly with long-term use or misuse. Abruptly stopping the medication after prolonged use can trigger withdrawal symptoms, ranging from mild rebound insomnia to more severe issues.

Signs of Ambien withdrawal can include:

  • Rebound insomnia
  • Anxiety and panic attacks
  • Nausea, vomiting, and stomach cramps
  • Tremors and sweating
  • Seizures (in rare, severe cases)

Comparison of Ambien vs. Other Sleep Aids

Side effect profiles differ among sleep aids. The following table provides a high-level comparison between Ambien (zolpidem) and another Z-drug, Lunesta (eszopiclone), regarding potential side effects.

Side Effect Ambien (Zolpidem) Lunesta (Eszopiclone)
Complex Sleep Behaviors Yes, with FDA boxed warning; high risk for specific activities like sleep-driving Yes, with FDA boxed warning; also linked to dangerous activities
Next-Day Impairment Common, particularly with higher doses; FDA lowered doses to mitigate risk Common, can cause lingering drowsiness and risk of impaired driving
Taste Changes Not a prominent side effect, though metallic taste is possible Often causes an unpleasant, bitter, or metallic aftertaste
Memory Impairment Possible, especially anterograde amnesia (forgetting events after taking the pill) Possible, but not as widely associated with the complex behavioral issues as Ambien
Dependence Risk Moderate, especially with long-term use; controlled substance Moderate, controlled substance; potential for habit-forming
Other Common Side Effects Dizziness, headache, nausea, diarrhea Dry mouth, headache, dizziness

Mitigating the risks

To minimize the risks associated with Ambien, it is crucial to use the medication exactly as prescribed. Never exceed the recommended dosage and only take it when you can commit to a full 7 to 8 hours of uninterrupted sleep. Mixing Ambien with alcohol or other central nervous system depressants, such as opioids or benzodiazepines, significantly increases the risk of dangerous side effects, including severe respiratory depression and overdose.

For those concerned about long-term use or dependence, alternatives to medication, such as cognitive behavioral therapy for insomnia (CBT-I), can be highly effective. A healthcare provider can help determine the most appropriate and safest treatment plan for your specific needs.

Conclusion

While Ambien can be an effective short-term solution for insomnia, its most significant and alarming side effect is the potential for complex sleep behaviors. This risk, highlighted by the FDA's boxed warning, underscores the importance of strict adherence to dosage guidelines and avoiding concurrent use of alcohol or other depressants. Other serious risks, such as next-day impairment and dependence, also make careful medical supervision essential. By understanding all potential side effects, patients and their caregivers can use this medication more safely or consider alternative therapies for managing sleep issues. For more details, refer to the FDA Drug Safety Communication.

Frequently Asked Questions

Complex sleep behaviors are activities performed while a person is not fully awake and has no memory of the event. They include sleep-driving, sleepwalking, making phone calls, and preparing food.

Yes, daytime drowsiness is a common side effect of Ambien, and it can linger into the next day, impairing alertness and coordination.

Yes, your ability to drive can be impaired the day after taking Ambien, even if you feel rested. The FDA has warned against driving or operating machinery until you know how the medication affects you.

While it is less likely to be habit-forming than some older medications, long-term use or misuse of Ambien can lead to physical dependence. Abruptly stopping can cause withdrawal symptoms.

Yes, Ambien can cause memory impairment, most notably anterograde amnesia, which is the inability to form new memories after taking the medication.

The boxed warning, the FDA's most serious warning, is for the risk of serious injuries and death caused by complex sleep behaviors such as sleep-driving, sleepwalking, and others.

Older adults are at a higher risk of side effects like confusion, falls, and dementia. Taking higher doses or combining Ambien with alcohol or other CNS depressants also increases the risk.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.