Two medicines, side by side
Eszopiclone vs zolpidem
Eszopiclone and zolpidem are both labeled for insomnia. Drugs@FDA records approvals of eszopiclone since 2004 and of zolpidem since 1992. Pharmacies paid $0.0993 per eszopiclone 1 mg tablet and $0.0344 per zolpidem tartrate 5 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the eszopiclone FDA label on DailyMed (effective January 30, 2026); the zolpidem FDA label on DailyMed (effective August 15, 2022).
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 zolpidem record
Zolpidem (Ambien) · label of August 15, 2022
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 Edluar. Some of these events may result in serious injuries, including death. Discontinue Edluar immediately if a patient experiences a complex sleep behavior [see Contraindications (4) and Warnings and Precautions (5.1) ]. WARNING: COMPLEX SLEEP BEHAVIORS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsEdluar (zolpidem tartrate) sublingual tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation [see Clinical Studies (14) ]. The clinical trials performed with zolpidem tartrate in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. […]
On the market
- Earliest approval on file
- December 16, 1992
- Generic labelers
- 39 labelers
- Pharmacy cost
- $0.0344 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 6
Source: FDA drug labels via openFDA (Eszopiclone label of January 30, 2026, Zolpidem label of August 15, 2022); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do eszopiclone and zolpidem differ on the record?
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 …”; Zolpidem, “Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing …”
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 …”; Zolpidem, “Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem …”
Both labels carry a boxed warning; the records quote them.
Generics: eszopiclone since 2011; zolpidem since 2007 (Drugs@FDA).
| Eszopiclone | Zolpidem | |
|---|---|---|
| Labeled for | Insomnia | Insomnia |
| Pharmacologic class | n/a | gamma-Aminobutyric Acid A Receptor Positive Modulator, gamma-Aminobutyric Acid-ergic 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. | Zolpidem is a GABA A receptor positive modulator presumed to exert its therapeutic effects in the short-term treatment of insomnia through binding to the benzodiazepine site of α 1 subunit containing GABA A receptors, increasing the … |
| 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. | Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem elimination half-life was 2.85 hours (range: 1.57-6.73 hr) and 2.65 hours (range: 1.75 to 3.77 hr) … |
| Earliest approval on file (Drugs@FDA) | December 15, 2004 | December 16, 1992 |
| First generic approved | May 23, 2011 | April 23, 2007 |
| Generic labelers (NDC) | 27 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.0993 per tablet (Eszopiclone 1 mg tablet) | $0.0344 per tablet (Zolpidem tartrate 5 mg tablet) |
| 12-month price change | -28% | -0.3% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 25,313 | 134,363 |
| DEA schedule | CIV | CIV |
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 )].
Zolpidem label, drug interactionsCNS-active Drugs CNS Depressants Co-administration of zolpidem with other CNS depressants increases the risk of CNS depression [see Warnings and Precautions (5.1 , 5.2) ].
Source: FDA drug labels via openFDA
What next?
- Alternatives to eszopiclone
- every medicine labeled for the same conditions