Eszopiclone: What Is It and What Are the Concerns?
Eszopiclone, sold under the brand name Lunesta, is a non-benzodiazepine sedative-hypnotic medication prescribed to treat insomnia. It is often referred to as a "Z-drug" due to its sedative effects, which are intended to help people fall asleep faster and stay asleep longer. While effective for many, eszopiclone is not without its risks. As a Schedule IV controlled substance, the U.S. Drug Enforcement Administration (DEA) recognizes it has potential for abuse and dependence, similar to, though generally considered less severe than, some benzodiazepines.
Prescribing practices emphasize using the lowest effective dose for the shortest duration necessary, as risks increase with dose and long-term use. Despite its designation as less addictive than some alternatives, misuse can still lead to significant problems.
The FDA's Boxed Warning for Complex Sleep Behaviors
One of the most serious safety issues associated with eszopiclone is the risk of complex sleep behaviors. In 2019, the FDA added a Boxed Warning—its strictest warning for medications—regarding this potential risk. These behaviors can occur even at the lowest recommended dose and may result in serious injuries or death.
Examples of complex sleep behaviors include:
- Sleep-driving: Driving a car while not fully awake and having no memory of the event.
- Sleepwalking: Engaging in activities like preparing and eating food, making phone calls, or walking around.
- Other activities: Performing other tasks, including having sex, while not fully conscious.
These incidents can happen to anyone taking eszopiclone, even those without a prior history of sleep disorders.
Potential for Dependence and Withdrawal
Eszopiclone carries a risk of both physical and psychological dependence. When used for prolonged periods or in higher doses than prescribed, the brain adapts to the drug's effects, leading to a need for increased dosage to achieve the same result (tolerance).
If the medication is stopped abruptly after regular use, withdrawal symptoms can occur. These can be uncomfortable and range from mild to severe. Medically supervised tapering is crucial to minimize these effects.
Common Withdrawal Symptoms:
- Anxiety and irritability
- Rebound insomnia (worse sleep problems than before treatment)
- Nausea and vomiting
- Stomach and muscle cramps
- Shakiness and sweating
- Rarely, seizures
Next-Day Impairment and Other Side Effects
Eszopiclone's sedative effects can persist well into the next day, causing decreased mental alertness, daytime drowsiness, and impaired coordination. The FDA lowered the recommended starting dose in 2014 to mitigate this risk, particularly for driving. Even if a person feels fully awake, they may still be impaired.
Other common and serious side effects include:
- Common: Unpleasant or metallic taste, headache, dry mouth, and dizziness.
- Serious: Aggressive behavior, confusion, hallucinations, worsening depression or suicidal thoughts, and severe allergic reactions (e.g., angioedema).
Comparison of Sleep Medications: Eszopiclone vs. Others
To put the risks into context, comparing eszopiclone with other common sedative-hypnotics is useful. It's important to note that all medications in this class carry risks.
| Feature | Eszopiclone (Lunesta) | Zolpidem (Ambien) | Zaleplon (Sonata) |
|---|---|---|---|
| Onset | Works quickly, typically within an hour. | Acts very rapidly, within about 15 minutes. | Very rapid onset of action. |
| Duration | Helps with falling and staying asleep, with effects lasting up to 8 hours. | Immediate-release version is shorter-acting (4-6 hours), while extended-release is longer. | Shorter-acting, primarily helps with falling asleep rather than staying asleep. |
| Next-Day Impairment | Possible, especially with higher doses. FDA lowered the recommended starting dose to reduce this risk. | More common with higher doses and less than 7-8 hours of sleep. An FDA warning led to lower recommended doses. | Less risk of next-day drowsiness due to its shorter duration. |
| Dependence/Abuse Potential | Controlled substance (Schedule IV) with a recognized potential for dependence and abuse. | Controlled substance (Schedule IV) with a higher potential for abuse and dependency, particularly with higher doses and prolonged use. | Controlled substance (Schedule IV), with a lower potential for dependence due to its short duration. |
| Complex Sleep Behaviors | Boxed Warning issued by the FDA. | Boxed Warning issued by the FDA. | Boxed Warning issued by the FDA. |
Who Is at Higher Risk?
While any user can experience side effects, certain individuals face a higher risk profile when taking eszopiclone:
- Elderly Patients: Older adults are more sensitive to the drug's effects, increasing their risk of confusion, dizziness, and falls. The maximum recommended dose for the elderly is lower.
- Patients with Liver Impairment: Severe liver disease can slow down the body's ability to process the medication, leading to increased drug levels and a higher risk of side effects. Dose adjustments are necessary.
- Individuals with a History of Substance Abuse: A history of drug or alcohol abuse increases the risk of developing dependence on eszopiclone.
- Patients with Mental Health Conditions: Those with depression or other mental illnesses may experience a worsening of their symptoms, including suicidal thoughts. The lowest possible dose should be prescribed, and patients should be closely monitored.
- Concurrent Use of Other CNS Depressants: Taking eszopiclone with other sedating substances, such as alcohol, opioids, or benzodiazepines, significantly increases the risk of side effects, including severe drowsiness and respiratory depression.
Conclusion: Is Eszopiclone a High Risk Medication?
In conclusion, while eszopiclone can be an effective treatment for insomnia, labeling it simply as a "high risk medication" is too simplistic. The reality is more nuanced: it carries significant and potentially serious risks that require careful consideration and medical supervision. The FDA has mandated its strictest warnings for complex sleep behaviors and potential for next-day impairment, demonstrating its serious safety profile. Furthermore, its classification as a controlled substance and documented potential for dependence, especially with prolonged or higher-dose use, means it must be managed responsibly.
For individuals with a history of substance abuse, mental health issues, or who are elderly, the risks are elevated and require extra caution. Open communication with a healthcare provider is essential to determine if eszopiclone is the right choice and to ensure it is used safely, with careful consideration of the benefits versus the potential harms. For more detailed information, you can read the FDA Drug Safety Communication on complex sleep behaviors associated with eszopiclone and other sleep aids.
Safe Use of Eszopiclone
To minimize risks, always follow your doctor’s orders precisely.
- Take the lowest effective dose for the shortest duration necessary.
- Take it immediately before you go to bed, on an empty stomach, and only if you can get a full 7-8 hours of sleep.
- Avoid alcohol and other CNS depressants while taking it.
- Do not drive or operate heavy machinery until you understand how the medication affects you.
- Never stop taking the medication abruptly; if you need to discontinue, consult your doctor about a tapering schedule.
