Insomnia is one of the most prevalent sleep disorders in the U.S., affecting millions of adults each year. Among the medications prescribed to treat it are zopiclone and eszopiclone — two related, non-benzodiazepine hypnotics designed for short-term management of sleep difficulties. But legality of zopiclone and eszopiclone and availability in the United States aren’t quite the same, and knowing the difference is essential if you’re seeking treatment or planning to bring these drugs into the country.
Here’s a clear and current explanation of how both drugs are regulated in the United States as of 2025.
What Are Zopiclone and Eszopiclone?
- Zopiclone is a cyclopyrrolone hypnotic developed in the 1980s and widely used around the world for short-term insomnia treatment. It helps you fall asleep faster and improves sleep maintenance.
- Eszopiclone, marketed in the U.S. under the brand name Lunesta, is the S-enantiomer of zopiclone. It was developed as a more refined version of zopiclone, with fewer side effects and a longer half-life, making it more suitable for patients who also wake up during the night.
Both drugs act by enhancing the effect of GABA, the brain’s main inhibitory neurotransmitter, promoting sedation and sleep.
Legality of Zopiclone and Eszopiclone in the United States
Eszopiclone
- Legal and FDA-approved.
- Eszopiclone was approved by the U.S. Food and Drug Administration (FDA) in 2004 for the treatment of insomnia.
- It is marketed under the brand name Lunesta and is available as a prescription medication nationwide.
- Classified as a Schedule IV controlled substance under the Controlled Substances Act (CSA), meaning it has a recognized medical use but also carries a risk of abuse and dependence.
Zopiclone
- Not FDA-approved for use in the U.S.
- Zopiclone itself is not marketed or prescribed in the United States. While it is approved in Canada, Europe, and other countries, the FDA never reviewed it for approval, largely because its enantiomer (eszopiclone) was already developed and marketed as an alternative.
- Importing zopiclone into the U.S. without proper authorization could result in seizure by customs.
Why the Difference?
Although zopiclone and eszopiclone are closely related, the FDA chose to approve only the S-enantiomer (eszopiclone), which was shown to offer similar therapeutic benefits with fewer adverse effects, such as metallic taste or grogginess. Pharmaceutical manufacturers focused their clinical trials and patent applications on eszopiclone, leaving no regulatory path for zopiclone itself.
How Are They Regulated?
Both zopiclone (if it were legal) and eszopiclone fall into the category of non-benzodiazepine hypnotics or “Z-drugs,” which are classified as Schedule IV under U.S. federal law. For eszopiclone:
- You need a prescription from a licensed healthcare provider.
- Refills are limited (up to 5 in a 6-month period) before a new prescription is required.
- Misuse or diversion can carry legal consequences.
For zopiclone:
- Not approved or prescribed.
- Importing or selling without FDA approval violates federal law.
What if You Bring Zopiclone Into the U.S. as a Traveler?
If you’re visiting the U.S. you may be able to carry a small personal supply (typically up to a 30-day supply) for personal use, provided it’s properly labeled and declared at customs. However, U.S. border agents have wide discretion to deny entry of unapproved drugs, even for personal medical use.
To avoid problems, it’s safer to switch to eszopiclone or consult a U.S.-licensed physician once in the country.
Summary Table: legality of Zopiclone vs. Eszopiclone in the U.S.
| Drug | FDA-Approved? | Controlled? | Schedule | Available? |
|---|---|---|---|---|
| Zopiclone | 🚫 No | 🚫 N/A | N/A | 🚫 No |
| Eszopiclone | ✅ Yes | ✅ Yes | IV | ✅ Yes |
Final Thoughts
If you’re looking for a legal, effective hypnotic in the U.S., eszopiclone (Lunesta) remains your best option. Zopiclone, while similar and popular internationally, is not approved for use in the United States and could cause legal trouble if imported without proper authorization.
Before starting or bringing any sleep medication into the country, consult a licensed U.S. healthcare provider and ensure your treatment plan complies with federal and state regulations.