Prescription medication · Melatonin Receptor Agonist
ramelteon
Also sold as Rozerem. Ramelteon is used to treat insomnia when you have trouble falling asleep.
Data updated 2026-05-15
- 7,215
- FDA reportsLightly reported
- 7
- InteractionsFew interactions
- 95% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
ramelteon (Rozerem) is a prescription Melatonin Receptor Agonist, reported less often than most tracked drugs (7,215 FDA reports), whose generic costs a fraction of the brand (about 95% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
ramelteon (Rozerem) is a prescription Melatonin Receptor Agonist. Ramelteon is used to treat insomnia when you have trouble falling asleep.
Ramelteon (Rozerem) is a prescription medicine that can help you fall asleep faster. It works by acting like a natural hormone in your brain that regulates sleep.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
ramelteon is currently listed as to be discontinued by the FDA. Affected manufacturer: Takeda Pharmaceuticals USA Inc..
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$12.38/unit
Generic Price
$0.64/unit
Generic Savings
95%
Generic Available
Yes (10 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Ramelteon is used to treat insomnia when you have trouble falling asleep.
Common side effects
Feeling sleepy, Dizziness, Feeling tired
Key warnings
Rarely, some people have had severe allergic reactions (angioedema and anaphylaxis) with throat closing, trouble breathing, nausea, or vomiting.
The sections below are summarized in plain English from ramelteon's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Ramelteon works by targeting receptors in your brain that are involved in the sleep-wake cycle. It acts like melatonin, a hormone your body makes naturally to help you sleep. By binding to these receptors, ramelteon helps to promote sleepiness.
How to Take It
Take one 8 mg tablet within 30 minutes before you go to bed. Do not take it with or right after a high-fat meal. Make sure you don't take more than one 8 mg tablet per day. If you have liver problems, talk to your doctor before taking this medicine.
This is a plain-language summary of ramelteon's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Talk to your doctor if you are pregnant or plan to become pregnant. Animal studies suggest a risk of birth defects at high doses. It is not known if ramelteon passes into breast milk. Talk to your doctor about the risks and benefits of breastfeeding while taking this medicine, and watch for sleepiness or feeding problems in the baby.
This is a plain-language summary of ramelteon's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, skip that dose and take your next dose at your regular time. Do not take two doses at once.
This is a plain-language summary of ramelteon's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store ramelteon tablets at room temperature (68° to 77°F) in a tightly closed container, away from moisture and humidity.
Side Effects (from patient reports)
Based on 7,215 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for ramelteon, by number of reports
- Trouble falling asleep
Trouble falling asleep
447 reports
- Sleepiness
Sleepiness
410 reports
- Waking up in the middle of the night
Waking up in the middle of the night
390 reports
- Trouble sleeping
Trouble sleeping
388 reports
- Feeling sick to your stomach
Feeling sick to your stomach
327 reports
- Tiredness
Tiredness
283 reports
- Feeling lightheaded
Feeling lightheaded
268 reports
- Head pain
Head pain
254 reports
- Sleep that is not restful
Sleep that is not restful
218 reports
- Loose stools
Loose stools
212 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for ramelteon each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where ramelteon sits
ramelteon has more FDA adverse-event reports than 32% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is ramelteon; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 7,215 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2005–2025.
Total Reports
7,215
Reports Mentioning Death
784
10.9% of reports — not proof of cause
Hospitalization Reports
2,039
Top Indication
Insomnia
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | INITIAL INSOMNIA | 447 |
| 3 | SOMNOLENCE | 411 |
| 4 | MIDDLE INSOMNIA | 390 |
| 5 | INSOMNIA | 388 |
| 6 | NAUSEA | 327 |
| 7 | FATIGUE | 283 |
| 8 | DIZZINESS | 268 |
| 9 | HEADACHE | 254 |
| 11 | POOR QUALITY SLEEP | 218 |
| 12 | DIARRHOEA | 212 |
| 13 | FEELING ABNORMAL | 208 |
| 14 | FALL | 203 |
| 15 | ANXIETY | 189 |
| 16 | PNEUMONIA | 182 |
| 17 | PYREXIA | 182 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Rarely, some people have had severe allergic reactions (angioedema and anaphylaxis) with throat closing, trouble breathing, nausea, or vomiting. If this happens, stop taking ramelteon and get medical help right away. Do not take ramelteon again if you've had this type of reaction to it. Ramelteon may cause changes in behavior, such as sleep-driving or hallucinations. It may also worsen depression or cause suicidal thoughts. Be careful driving or operating machinery, as ramelteon can affect your alertness.
Known Drug Interactions
( 7.1 ) Ketoconazole (strong CYP3A4 inhibitor): Increases AUC for ramelteon; administer with caution. Ketoconazole (strong CYP3A4 inhibitor) The AUC 0-inf and C max of ramelteon increased by approximately 84% and 36% upon coadministration of ketoconazole with ramelteon. Ramelteon should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see Clinical Pharmacology (12.5) ] .
Mechanism: Ketoconazole blocks the enzyme that breaks down ramelteon, which causes the sleep medicine to build up in your body.
What to do: Use this combination with caution and talk to your doctor about watching for increased side effects.
( 7.1 ) Fluconazole (strong CYP2C9 inhibitor): Increases systemic exposure of ramelteon; administer with caution. Fluconazole (strong CYP2C9 inhibitor) The AUC 0-inf and C max of ramelteon was increased by approximately 150% when ramelteon was coadministered with fluconazole. Ramelteon should be administered with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole [see Clinical Pharmacology (12.5) ] .
Mechanism: Fluconazole stops the body from processing ramelteon normally, which leads to much higher levels of the drug in your system.
What to do: Use these drugs together with caution and tell your doctor if you feel overly sleepy.
( 7.1 ) Donepezil: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with donepezil. Donepezil The AUC 0-inf and C max of ramelteon increased by approximately 100% and 87%, respectively upon coadministration of donepezil with ramelteon. Patients should be closely monitored when ramelteon is coadministered with donepezil [see Clinical Pharmacology (12.5) ] .
Mechanism: Donepezil makes it harder for your body to get rid of ramelteon, leading to higher levels of the drug in your blood.
What to do: Your doctor should watch you closely for increased sleepiness or other side effects while taking both drugs.
( 7.1 ) Doxepin: Increases systemic exposure of ramelteon; patients should be closely monitored when ramelteon is coadministered with doxepin. Doxepin The AUC 0-inf and C max of ramelteon increased by approximately 66% and 69%, respectively, upon coadministration of doxepin with ramelteon. Patients should be closely monitored when ramelteon is coadministered with doxepin [see Clinical Pharmacology (12.5) ] .
Mechanism: Taking doxepin can raise the levels of ramelteon in your body by slowing down its breakdown.
What to do: You should be monitored closely by your healthcare provider to ensure the combination is safe for you.
7 DRUG INTERACTIONS Rifampin (strong CYP enzyme inducer): Decreases exposure to and effects of ramelteon. Rifampin (strong CYP enzyme inducer) Administration of multiple doses of rifampin resulted in a mean decrease of approximately 80% in total exposure to ramelteon and metabolite M-II. Efficacy may be reduced when ramelteon is used in combination with strong CYP enzyme inducers such as rifampin [see Clinical Pharmacology (12.5) ] .
Mechanism: Rifampin causes your body to break down ramelteon much faster than normal, which lowers the amount of medicine in your system.
What to do: Because this may make ramelteon work less effectively, your doctor may need to change your treatment plan.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I take ramelteon with other medications?
Can I drink alcohol while taking ramelteon?
What should I do if I still can't sleep after taking ramelteon for a week?
Can ramelteon cause any changes in my thinking or behavior?
Will ramelteon affect my ability to drive or operate machinery?
Can ramelteon affect my hormones?
Is ramelteon safe for people with sleep apnea?
What do the tablets look like?
What if I accidentally take too much?
Can children take ramelteon?
What are the common side effects of ramelteon?
Does ramelteon interact with other medications?
What drug class is ramelteon?
Is there a generic version of ramelteon?
Is ramelteon safe during pregnancy?
Is ramelteon currently in shortage?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for ramelteon
The FDA label for ramelteon (sold under brand names such as Rozerem) classifies it as a prescription-only medication in the Melatonin Receptor Agonist class. Ramelteon is used to treat insomnia when you have trouble falling asleep. Official labeling lists 5 commonly reported side effects, including Feeling sleepy, Dizziness, Feeling tired.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 7,215 voluntary reports. The database also lists 7 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.64 versus $12.38 for the brand - a 95% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: May 17, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages