| Generic Name | Zopiclone |
| Brand Names | Lunesta (USA) · Imovane (Canada) · Zimovane (UK/Europe/Australia) |
| Drug Class | Non-Benzodiazepine Hypnotic (Z-Drug) / Cyclopyrrolone |
| FDA Approval Status | FDA-Approved (as eszopiclone, the active S-enantiomer) — 2004 |
| DEA Schedule | Schedule IV Controlled Substance |
| Standard Adult Dose | 5–10 mg taken immediately before bed |
| Half-Life | 5–7 hours (eszopiclone); allows morning alertness |
| Onset of Action | 15–30 minutes |
| Primary Indication | Insomnia (sleep initiation and maintenance) |
| Dependence Risk | Moderate (lower than benzodiazepines, but real) |
| Generic Available | Yes — widely available since 2012 (significant cost savings) |
| Pregnancy Category | Category C (use only if benefits clearly outweigh risks) |
Zopiclone is a prescription sedative-hypnotic medication belonging to a class known as non-benzodiazepine hypnotics, commonly abbreviated as "Z-drugs" or "Z-class agents." Developed in France in 1986 and introduced to European markets in the late 1980s, zopiclone represents a pharmacologically distinct departure from classical benzodiazepines, offering hypnotic efficacy with a theoretically reduced dependence liability—a distinction that has proven partially, though not completely, accurate in clinical practice.
In the United States, zopiclone is marketed under the brand name Lunesta as eszopiclone (pronounced "es-ZOP-ih-clone"), which is the pharmacologically active S-enantiomer of the racemic zopiclone molecule. The FDA approved eszopiclone in 2004, specifically for the treatment of insomnia—both difficulty falling asleep (sleep initiation) and difficulty staying asleep (sleep maintenance). This distinction from older hypnotics is clinically significant: eszopiclone is one of the few sleep medications with FDA approval for both onset and maintenance insomnia, making it a versatile option for patients whose sleep disturbance is not limited to bedtime.
Structurally, zopiclone belongs to the cyclopyrrolone chemical class, a group that interacts with the central nervous system's GABA-A receptors in a more selective fashion than benzodiazepines, primarily targeting the alpha-1 subunit. This selectivity contributes to its hypnotic potency while theoretically reducing muscle relaxant and anti-convulsant side effects that are hallmark features of broader-spectrum benzodiazepine activity. Following patent expiration, generic zopiclone and eszopiclone have become widely available in the United States since 2012, significantly reducing out-of-pocket costs for patients.
Zopiclone is FDA-approved and legally available in the United States by prescription only, classified as a Schedule IV controlled substance under the Controlled Substances Act. A valid prescription issued by a licensed U.S. physician, nurse practitioner, or physician assistant is required to obtain zopiclone legally from any regulated pharmacy—whether in-person or through a licensed telehealth platform.
It is important to note a regulatory distinction: the FDA does not approve the racemic mixture of zopiclone as sold internationally. Instead, the U.S. FDA approved eszopiclone (Lunesta) in December 2004, following a New Drug Application (NDA) review. Eszopiclone is the purified S-enantiomer of zopiclone, considered the pharmacologically active form. The racemic zopiclone sold in Canada, Europe, and most other countries contains both the S- and R-enantiomers; the R-form is largely inactive for sleep induction but may contribute to residual side effects. For this reason, therapeutic doses of generic zopiclone outside the USA are typically 7.5 mg, whereas FDA-approved eszopiclone doses begin at 1 mg and extend to 3 mg per dose—a meaningful difference.
Purchasing zopiclone (including branded products like Imovane from Canada or Zimovane from Europe) without a valid U.S. prescription and importing it into the United States is illegal under federal law. Possession of controlled substances without a valid prescription can result in federal charges. Additionally, such purchases expose consumers to counterfeit products, incorrect dosages, and unknown impurities. Always obtain zopiclone through a licensed U.S. prescriber and a pharmacy accredited by the National Association of Boards of Pharmacy (NABP) or equivalent regulatory authority.
Understanding zopiclone's position within the broader landscape of sleep pharmacotherapy is essential for informed decision-making. The table below compares zopiclone (eszopiclone) to other commonly prescribed and emerging hypnotic agents:
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