Two medicines, side by side
Ramelteon vs zaleplon
Ramelteon and zaleplon are both labeled for insomnia. Drugs@FDA records approvals of ramelteon since 2005 and of zaleplon since 1999. Pharmacies paid $0.660 per ramelteon 8 mg tablet and $0.141 per zaleplon 10 mg capsule (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 zaleplon a gamma-aminobutyric acid a receptor agonist.
Check it at the source: the ramelteon FDA label on DailyMed (effective April 15, 2026); the zaleplon FDA label on DailyMed (effective May 8, 2024).
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 zaleplon record
Zaleplon (Sonata) · label of May 8, 2024
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 zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior (see CONTRAINDICATIONS and Complex Sleep Behaviors under WARNINGS ). Zaleplon is a federally controlled substance (C-IV) because it can be abused or lead to dependence.
Used for
From the label: indicationsZaleplon capsules are indicated for the short-term treatment of insomnia. Zaleplon capsules have been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). They have not been shown to increase total sleep time or decrease the number of awakenings. […]
On the market
- Earliest approval on file
- August 13, 1999
- Generic labelers
- 9 labelers
- Pharmacy cost
- $0.141 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Ramelteon label of April 15, 2026, Zaleplon label of May 8, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ramelteon and zaleplon differ on the record?
In FDA's classes, ramelteon is a melatonin receptor agonist and zaleplon a gamma-aminobutyric acid a receptor agonist.
Only the zaleplon label carries a boxed warning.
Generics: ramelteon since 2013; zaleplon since 2008 (Drugs@FDA).
DEA schedule: ramelteon none; zaleplon CIV.
| Ramelteon | Zaleplon | |
|---|---|---|
| Labeled for | Insomnia | Insomnia |
| Pharmacologic class | Melatonin Receptor Agonist | gamma-Aminobutyric Acid A Receptor 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. | n/a |
| 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). | n/a |
| Earliest approval on file (Drugs@FDA) | July 22, 2005 | August 13, 1999 |
| First generic approved | July 26, 2013 | June 6, 2008 |
| Generic labelers (NDC) | 27 labelers | 9 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.660 per tablet (Ramelteon 8 mg tablet) | $0.141 per capsule (Zaleplon 10 mg capsule) |
| 12-month price change | -11% | -10% |
| Boxed warning | No | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 0 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 7,347 | 1,589 |
| 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?
Zaleplon label, warningsCoadministration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression.
Source: FDA drug labels via openFDA
What next?
- Alternatives to ramelteon
- every medicine labeled for the same conditions