Two medicines, side by side
Ramelteon vs doxepin
Ramelteon and doxepin are both labeled for insomnia. Drugs@FDA records approvals of ramelteon since 2005 and of doxepin since 1969. Pharmacies paid $0.660 per ramelteon 8 mg tablet and $0.0779 per doxepin 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 doxepin a tricyclic antidepressant.
Check it at the source: the ramelteon FDA label on DailyMed (effective April 15, 2026); the doxepin FDA label on DailyMed (effective December 30, 2025).
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 doxepin record
Doxepin (Sinequan) · label of December 30, 2025
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of doxepin hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need.
Used for
From the label: indicationsDoxepin Hydrochloride is recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). […]
On the market
- Earliest approval on file
- September 23, 1969
- Generic labelers
- 49 labelers
- Pharmacy cost
- $0.0779 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Source: FDA drug labels via openFDA (Ramelteon label of April 15, 2026, Doxepin label of December 30, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do ramelteon and doxepin differ on the record?
In FDA's classes, ramelteon is a melatonin receptor agonist and doxepin a tricyclic antidepressant.
Only the doxepin label carries a boxed warning.
Generics: ramelteon since 2013; doxepin since 1986 (Drugs@FDA).
| Ramelteon | Doxepin | |
|---|---|---|
| Labeled for | Insomnia | Depression, Anxiety, Eczema (atopic dermatitis), Insomnia |
| Pharmacologic class | Melatonin Receptor Agonist | Tricyclic Antidepressant |
| 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 | September 23, 1969 |
| First generic approved | July 26, 2013 | May 13, 1986 |
| Generic labelers (NDC) | 27 labelers | 49 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.660 per tablet (Ramelteon 8 mg tablet) | $0.0779 per capsule (Doxepin 10 mg capsule) |
| 12-month price change | -11% | -9% |
| Boxed warning | No | Yes |
| Shortage now | A presentation being discontinued | No current entry |
| Recalls recorded | 0 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 7,347 | 12,554 |
| DEA schedule | none | 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)
Do their labels mention each other?
Ramelteon label, drug interactionsIncreases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin.
Source: FDA drug labels via openFDA
What next?
- Alternatives to ramelteon
- every medicine labeled for the same conditions