Two medicines, side by side
Ramelteon vs zolpidem
Ramelteon and zolpidem are both labeled for insomnia. Drugs@FDA records approvals of ramelteon since 2005 and of zolpidem since 1992. Pharmacies paid $0.660 per ramelteon 8 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. In FDA's classes, ramelteon is a melatonin receptor agonist and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
Check it at the source: the ramelteon FDA label on DailyMed (effective April 15, 2026); the zolpidem FDA label on DailyMed (effective August 15, 2022).
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
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 (Ramelteon label of April 15, 2026, Zolpidem label of August 15, 2022); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ramelteon and zolpidem differ on the record?
In FDA's classes, ramelteon is a melatonin receptor agonist and zolpidem a gamma-aminobutyric acid a receptor positive modulator.
How each works, in its label's words: 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.”; 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: Ramelteon, “Repeated once daily dosing with ROZEREM does not result in significant accumulation owing to the short elimination …”; Zolpidem, “Elimination: When Edluar administered as a single 5 or 10 mg dose in healthy adult subjects, the mean zolpidem …”
Only the zolpidem label carries a boxed warning.
Generics: ramelteon since 2013; zolpidem since 2007 (Drugs@FDA).
DEA schedule: ramelteon none; zolpidem CIV.
| Ramelteon | Zolpidem | |
|---|---|---|
| Labeled for | Insomnia | Insomnia |
| Pharmacologic class | Melatonin Receptor Agonist | gamma-Aminobutyric Acid A Receptor Positive Modulator, gamma-Aminobutyric Acid-ergic Agonist |
| How it works (label) | 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. | 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) | 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). | 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) | July 22, 2005 | December 16, 1992 |
| First generic approved | July 26, 2013 | April 23, 2007 |
| Generic labelers (NDC) | 27 labelers | 39 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.660 per tablet (Ramelteon 8 mg tablet) | $0.0344 per tablet (Zolpidem tartrate 5 mg tablet) |
| 12-month price change | -11% | -0.3% |
| Boxed warning | No | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 0 | 6 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 7,347 | 134,363 |
| DEA schedule | none | 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?
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 ramelteon
- every medicine labeled for the same conditions