Two medicines, side by side
Eszopiclone vs ramelteon
Eszopiclone and ramelteon are both labeled for insomnia. Drugs@FDA records approvals of eszopiclone since 2004 and of ramelteon since 2005. Pharmacies paid $0.0993 per eszopiclone 1 mg tablet and $0.660 per ramelteon 8 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the eszopiclone label carries a boxed warning.
Check it at the source: the eszopiclone FDA label on DailyMed (effective January 30, 2026); the ramelteon FDA label on DailyMed (effective April 15, 2026).
Highlights of the eszopiclone record
Eszopiclone (Lunesta) · label of January 30, 2026
COMPLEX SLEEP BEHAVIORS Complex sleep behaviors including sleep-walking, sleep-driving, and engaging in other activities while not fully awake may occur following use of eszopiclone tablets. Some of these events may result in serious injuries, including death. Discontinue eszopiclone tablets immediately if a patient experiences a complex sleep behavior [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )].
Used for
From the label: indicationsEszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. […]
On the market
- Earliest approval on file
- December 15, 2004
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.0993 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Highlights of the ramelteon record
Ramelteon (Rozerem) · label of April 15, 2026
Used for
From the label: indicationsROZEREM ® is indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration. […]
On the market
- Earliest approval on file
- July 22, 2005
- Generic labelers
- 27 labelers
- Pharmacy cost
- $0.660 per tablet
Supply and safety
- Shortage
- A presentation being discontinued
- Recalls
- 0
Source: FDA drug labels via openFDA (Eszopiclone label of January 30, 2026, Ramelteon label of April 15, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do eszopiclone and ramelteon differ on the record?
Only the eszopiclone label carries a boxed warning.
How each works, in its label's words: Eszopiclone, “The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or …”; Ramelteon, “Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT 1 and MT 2 receptors and relative selectivity over the MT 3 receptor.”
Half-life, in each label's words: Eszopiclone, “Eszopiclone is rapidly absorbed, with a time to peak concentration (t max ) of approximately 1 hour and a …”; Ramelteon, “Repeated once daily dosing with ROZEREM does not result in significant accumulation owing to the short elimination …”
Generics: eszopiclone since 2011; ramelteon since 2013 (Drugs@FDA).
DEA schedule: eszopiclone CIV; ramelteon none.
| Eszopiclone | Ramelteon | |
|---|---|---|
| Labeled for | Insomnia | Insomnia |
| Pharmacologic class | n/a | Melatonin Receptor Agonist |
| How it works (label) | The mechanism of action of eszopiclone as a hypnotic is unclear; however, its effect could be related to its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. | Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT 1 and MT 2 receptors and relative selectivity over the MT 3 receptor. |
| Half-life (label) | Eszopiclone is rapidly absorbed, with a time to peak concentration (t max ) of approximately 1 hour and a terminal-phase elimination half-life (t 1/2 ) of approximately 6 hours. | Repeated once daily dosing with ROZEREM does not result in significant accumulation owing to the short elimination half-life of ramelteon (on average, approximately one to 2.6 hours). |
| Earliest approval on file (Drugs@FDA) | December 15, 2004 | July 22, 2005 |
| First generic approved | May 23, 2011 | July 26, 2013 |
| Generic labelers (NDC) | 27 labelers | 27 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0993 per tablet (Eszopiclone 1 mg tablet) | $0.660 per tablet (Ramelteon 8 mg tablet) |
| 12-month price change | -28% | -11% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | A presentation being discontinued |
| Recalls recorded | 2 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 25,313 | 7,347 |
| DEA schedule | CIV | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What do the labels say about using others of their kind?
Eszopiclone label, warnings and precautionsThe risk of next-day psychomotor impairment is increased if eszopiclone is taken with less than a full night of sleep remaining (7 to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants; or coadministered with other drugs that increase the blood levels of eszopiclone [see Dosage and Administration ( 2.3 ) and Clinical Studies ( 14.3 )].
Source: FDA drug labels via openFDA
What next?
- Alternatives to eszopiclone
- every medicine labeled for the same conditions