Zopiclone is a widely recognized prescription medication used to treat insomnia and other sleep-related disorders. In this article we will talk over legality of Zopiclone in the US. Part of the “Z-drug”
a class of non-benzodiazepine medications commonly prescribed to treat insomnia and other sleep disorders. They include zolpidem, zaleplon, and eszopiclone — each known for their quick onset of action and relatively short half-life, which helps users fall asleep faster without prolonged sedation the next day. Unlike older sleeping pills, Z-drugs act on the GABA-A receptor complex but with a more targeted effect, reducing the risk of dependence and side effects seen with benzodiazepines. Despite this, prolonged use can still lead to tolerance, dependence, or withdrawal symptoms. Z-drugs are widely used due to their effectiveness and generally favorable side effect profile, though concerns remain about memory disturbances, next-day drowsiness, and sleepwalking episodes.

These medications are typically prescribed for short-term use under medical supervision to minimize risks. In many countries, Z-drugs are controlled substances and require a prescription due to their potential for misuse. Although it is commonly prescribed in Europe, Canada, UK and Australia, its legal status in the United States is distinctly different.

Is Zopiclone Legal in the USA?

As of now, zopiclone is not approved by the U.S. Food and Drug Administration (FDA). This means it cannot be legally marketed, distributed, or prescribed by healthcare professionals within the country. Despite being approved and used widely abroad under brand names like Imovane, the drug has never been granted FDA approval due to various regulatory, clinical, and pharmacological considerations.

Instead, the U.S. has approved eszopiclone, the isolated active S-enantiomer of zopiclone. Marketed under the name Lunesta, eszopiclone is thought to offer similar benefits but with improved tolerability and fewer side effects. It remains one of the most commonly prescribed medications for sleep initiation and maintenance in the U.S. healthcare system.

Why Isn’t Zopiclone Approved in the USA?

The primary reason for zopiclone’s unavailability in the United States is regulatory preference. Pharmaceutical companies often focus on drugs that demonstrate higher efficacy, fewer side effects, or a cleaner pharmacological profile. Eszopiclone, being a more refined version of zopiclone, offered a potentially better safety and efficacy ratio in clinical trials. Therefore, only eszopiclone underwent the FDA’s approval process.

Additionally, introducing a racemic drug like zopiclone when a more targeted enantiomer (eszopiclone) is already approved does not align with the FDA’s priorities, especially when the therapeutic differences are marginal.

Can You Legally Import Zopiclone?

Under U.S. import regulations, bringing zopiclone into the country—even for personal use—is technically illegal. The FDA restricts the import of unapproved medications, and U.S. Customs may seize shipments. However, reports suggest many individuals purchase it online from foreign pharmacies, thus, legality of zopiclone is something, that is not perfectly regulated.

While law enforcement typically focuses on large-scale importation, individual buyers are not entirely immune from scrutiny.

Alternatives to Zopiclone in the U.S.

If you are seeking something similar to zopiclone for managing insomnia, the following are FDA-approved alternatives available through prescription:

• Eszopiclone (Lunesta): The closest pharmaceutical relative to zopiclone.
• Zolpidem (Ambien): Another popular Z-drug used to initiate sleep.
• Zaleplon (Sonata): Shorter-acting Z-drug suitable for falling asleep quickly.
• Trazodone: An antidepressant often prescribed off-label for sleep disorders.
• Doxepin (Silenor): Low-dose tricyclic antidepressant used for insomnia.

For those preferring natural options, melatonin supplements, valerian root, and cognitive behavioral therapy for insomnia (CBT-I) are also gaining popularity as safer, long-term solutions.

Conclusion

While zopiclone remains a mainstream insomnia treatment worldwide, its use in the United States is not sanctioned by the FDA, the legality of zopiclone stands in grey area. Americans seeking relief from sleep disturbances have access to a range of legal alternatives, including Lunesta, which is pharmacologically close to zopiclone. Importing the drug from abroad is risky and potentially illegal, so it is strongly recommended to consult with a healthcare professional for safe and legal options. As the regulatory landscape continues to evolve, it’s essential to stay informed about what’s allowed—and what’s not—when it comes to medications in the U.S.