Is zopiclone banned in the USA?

is zopiclone banned in the USA

Zopiclone is a medication used to treat insomnia by promoting sleep through its sedative and hypnotic effects. While it is commonly prescribed in several countries, including Canada, the UK, and Australia, zopiclone is not approved for use in the United States. Can we say zopiclone is banned in the USA? No. It is not explicitly “banned”; rather, the U.S. Food and Drug Administration (FDA) has not approved the medication for sale or prescription.

Why Is Zopiclone Not FDA-Approved?

  1. Alternative Medications: In the United States, similar drugs like eszopiclone (marketed as Lunesta) are approved. Eszopiclone is the active stereoisomer of zopiclone, meaning it is a refined version designed to offer comparable therapeutic effects with potentially fewer side effects.
  2. Concerns About Side Effects: Zopiclone has been associated with side effects like drowsiness, dizziness, and a metallic aftertaste. Additionally, some studies have linked zopiclone to dependence, withdrawal symptoms, and cognitive impairments. These risks may have influenced the FDA’s decision not to approve it.
  3. Regulatory Variances: Drug approval processes vary by country. The FDA has stringent criteria regarding clinical trials, safety profiles, and long-term studies, which zopiclone may not have fully met according to their guidelines.

Zopiclone vs. Eszopiclone

Zopiclone and eszopiclone are both medications used to treat insomnia, but they differ in terms of their pharmacological profiles, regulatory status, and clinical use. Below is a detailed comparison of these two sleep aids, covering their similarities, differences, and practical considerations for patients and healthcare providers.

Overview of Zopiclone and Eszopiclone

  • Zopiclone: A sedative-hypnotic drug classified as a non-benzodiazepine. It is used in many countries, such as Canada, the UK, and Australia, for short-term insomnia treatment. It is not FDA-approved in the United States.
  • Eszopiclone (Lunesta): The S-enantiomer of zopiclone, it is a refined version of the drug approved by the FDA in the U.S. for the treatment of both short-term and chronic insomnia. Eszopiclone is marketed as Lunesta.

Pharmacology

  • Chemical Relationship:
    • Zopiclone is a racemic mixture (50:50 of two enantiomers), whereas eszopiclone contains only the active S-enantiomer, making it a more targeted option with potentially fewer side effects.
  • Mechanism of Action:
    • Both drugs work by enhancing the activity of gamma-aminobutyric acid (GABA) at GABA-A receptors, promoting sedation and reducing wakefulness.
  • Duration of Action:
    • Zopiclone: Provides 6–8 hours of sleep aid but may cause residual drowsiness in some individuals.
    • Eszopiclone: Similar duration but is designed to minimize next-day impairment, especially at lower doses.

Efficacy and Clinical Use

  • Zopiclone:
    • Effective in initiating and maintaining sleep.
    • Often prescribed for short-term use due to concerns about dependence and withdrawal.
  • Eszopiclone:
    • Demonstrates efficacy for both short-term and long-term insomnia.
    • Approved for extended use, which makes it a preferred option for chronic insomnia in the U.S.

Side Effects

  • Common Side Effects:
    • Both drugs can cause dizziness, dry mouth, and a metallic taste (notably stronger with zopiclone).
  • Next-Day Impairment:
    • Zopiclone may lead to residual sedation, increasing the risk of impaired driving or accidents.
    • Eszopiclone’s lower doses aim to reduce the risk of next-day drowsiness.
  • Dependency and Tolerance:
    • Both drugs carry a risk of dependence if used long-term. Eszopiclone is considered slightly safer for extended use.

Availability and Regulatory Status

  • Zopiclone:
    • Approved in many countries but not in the U.S. due to safety and efficacy concerns raised during the FDA approval process.
    • Available in generic forms internationally, making it more affordable.
  • Eszopiclone:
    • Widely available in the U.S. under the brand name Lunesta.
    • FDA-approved, which ensures rigorous testing for quality and safety.

Cost and Accessibility

  • Zopiclone: Often cheaper and more accessible in countries where it is approved due to its availability in generic form.
  • Eszopiclone: More expensive, especially in the U.S., where it is primarily sold as a branded medication.

Alternatives to Zopiclone in the U.S.

For patients in the U.S. seeking treatment for insomnia, the following alternatives are commonly prescribed:

  • Eszopiclone (Lunesta): A close relative of zopiclone, it offers similar benefits with FDA approval.
  • Zolpidem (Ambien): Another non-benzodiazepine hypnotic widely used for short-term insomnia management.
  • Trazodone: Often prescribed off-label for sleep disorders, particularly in patients with co-existing depression.
  • Ramelteon (Rozerem): A melatonin receptor agonist used for sleep onset insomnia.

Can Zopiclone Be Obtained in the U.S.?

Since zopiclone is not FDA-approved, it cannot be legally marketed or prescribed in the U.S. However, some individuals may obtain it through online international pharmacies. This practice carries risks:

  • The medication may be counterfeit or of poor quality.
  • Importing unapproved drugs violates FDA regulations.
  • Legal consequences could arise if the medication is seized at customs.

Conclusion

Is Zopiclone banned in the United States? No. but it is unapproved by the FDA for use due to the availability of alternative medications and concerns regarding its safety profile. Individuals seeking treatment for insomnia should consult a healthcare provider for FDA-approved options tailored to their needs.