Ramelteon
Pronunciation: pronunciation varies by local usage.
- Generic name
- ramelteon
- Brand names
- ROZEREM
- Drug class
- Melatonin receptor agonist
- Form
- Tablet
- Route
- Oral
- Legal status
- Prescription-only medicine
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What ramelteon is and how it works
Ramelteon is a melatonin receptor agonist indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
Ramelteon is taken once daily at bedtime. It is not a controlled substance and has no known abuse potential. Patients should avoid hazardous activities after taking.
Mechanism of action: how ramelteon works
Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors, thought to support sleep onset. (1)
What ramelteon is used for
Insomnia with difficulty with sleep onset
Ramelteon is indicated for the treatment of insomnia characterized by difficulty with sleep onset. (1)
Before taking ramelteon
Do not take / not appropriate for
- Do not take ramelteon if you have a history of angioedema (swelling of the face, tongue, or throat) while taking ramelteon. (all patients) (1)
- Do not take ramelteon if you are also taking fluvoxamine (a strong CYP1A2 inhibitor). (all patients) (1)
Tell your clinician about
- Any history of swelling of the face, tongue, or throat (angioedema) after taking ramelteon or any medicine.
- Current use of fluvoxamine (Luvox).
- Symptoms of depression, mood changes, or suicidal thoughts.
- Experiences of sleep-driving, sleep-walking, or other unusual behavior while sleeping.
- Failure of insomnia to improve after 7 to 10 days of treatment.
- Pregnancy, plans for pregnancy, or breastfeeding.
- Liver problems, including any history of liver disease.
- All other prescription and nonprescription medicines, herbal products, and dietary supplements, especially rifampin, ketoconazole, fluconazole, doxepin, or alcohol.
How to take ramelteon
- Take 8 mg of ramelteon by mouth within 30 minutes before going to bed. Do not take more than 8 mg in a day.
- Do not take ramelteon with or immediately after a high-fat meal, as this may reduce its effectiveness.
- After taking ramelteon, avoid activities that require mental alertness, such as driving or operating machinery, until you are fully awake.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
The US label and its medication guide do not provide missed-dose instructions for ramelteon. Because it is taken within 30 minutes of going to bed and not with or after a high-fat meal, ask your prescriber or pharmacist what to do about a missed night rather than changing the routine yourself.
Overdose
Overdose is managed by clinicians with general symptomatic and supportive measures — the label describes gastric lavage where appropriate, intravenous fluids as needed, and vital-sign monitoring, and notes that hemodialysis does not effectively reduce ramelteon exposure. Contact a poison-information service or seek emergency care if an overdose is suspected. (1)
Side effects
The most common adverse reactions (occurring in ≥3% of patients and more than placebo) are somnolence, fatigue, dizziness, nausea, and exacerbated insomnia.
Somnolence (sleepiness)
What to notice: Excessive drowsiness or difficulty staying awake.
What to do: If persistent or severe, contact the prescribing clinician. Avoid hazardous activities. (1)
Fatigue
What to notice: Feeling unusually tired or lacking energy.
What to do: Discuss with the treating clinician if troublesome; do not stop treatment without consulting them. (1)
Dizziness
What to notice: Feeling lightheaded or unsteady.
What to do: Change positions slowly; report persistent or severe dizziness to the prescriber. (1)
Nausea
What to notice: Stomach discomfort or queasiness.
What to do: Taking ramelteon on an empty stomach may help; inform the clinician if nausea is bothersome. (1)
Exacerbated insomnia
What to notice: Difficulty sleeping that gets worse instead of better.
What to do: Contact the prescriber; they may re-evaluate your condition. (1)
Angioedema or severe allergic reaction
What to notice: Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing.
What to do: Seek emergency medical attention immediately; let the prescriber decide whether you can take ramelteon again. (1)
Complex sleep behaviors
What to notice: Sleep-driving, sleep-walking, or engaging in activities while asleep with no memory of the event.
What to do: Report these events to the prescriber promptly; they will determine whether treatment should continue. (1)
Worsening depression or suicidal thoughts
What to notice: Worsening depressed mood, new or increased suicidal thoughts or behaviors, unusual changes in behavior.
What to do: Report mood changes promptly to the treating clinician. (1)
Serious warnings
Anaphylaxis and Angioedema — emergency
Symptoms: Swelling of the face, tongue, or throat; difficulty breathing; hives; or feeling faint.
Action: Seek emergency medical care immediately; the prescriber will decide whether ramelteon can be used again. (1)
Complex sleep behaviors — serious
Symptoms: Sleep-driving, sleep-walking, or other activities during sleep with amnesia.
Action: Report these events to the prescriber promptly; let the prescriber decide if treatment should continue. (1)
Worsening depression or suicidal ideation — serious
Symptoms: Deepening depression, suicidal thoughts or actions, or any unusual changes in mood or behavior.
Action: Contact the treating clinician promptly for evaluation. (1)
Next-day psychomotor impairment — caution
Symptoms: Dizziness, drowsiness, reduced coordination, difficulty concentrating the next morning.
Action: Avoid driving or operating machinery after taking ramelteon. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Fluvoxamine (Luvox) | Strong CYP1A2 inhibitor; increases ramelteon exposure about 190-fold. | Do not use ramelteon with fluvoxamine. (1) |
| Rifampin | Induces CYP enzymes; reduces ramelteon exposure by about 80%. | Ramelteon may be less effective; the prescriber may consider an alternative. (1) |
| Azole antifungals (ketoconazole, fluconazole) | Inhibit CYP enzymes; ketoconazole increases ramelteon AUC about 84%, fluconazole about 150%. | Use ramelteon with caution and monitor for increased side effects; the prescriber will make decisions about combination therapy. (1) |
| Doxepin | Inhibits CYP1A2; increases ramelteon AUC about 66%. | Monitor closely for adverse effects if combined; the prescriber decides on use. (1) |
| Alcohol | Adds to nervous system impairment, increasing psychomotor impairment. | Do not consume alcohol in combination with ramelteon. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Ramelteon has not been studied in pregnant women. Animal studies showed developmental effects only at very high doses. The clinician will weigh the benefits and risks if ramelteon is considered during pregnancy. Do not start or stop ramelteon without consulting your clinician. (1)
Breastfeeding
Ramelteon passes into animal milk; it is not known if it is excreted in human milk. Breastfed infants should be monitored for somnolence if the mother is taking ramelteon. The prescriber will decide on the need for the medicine during breastfeeding. (1)
Hepatic impairment
Use ramelteon with caution in patients with moderate hepatic impairment. It is not recommended in severe hepatic impairment due to markedly increased exposure. Inform your clinician if you have any liver condition. (1)
Monitoring
Before starting
- Confirm diagnosis of insomnia with difficulty with sleep onset and rule out other causes.
- Assess for history of angioedema, drug interactions, liver function, pregnancy, and depression.
- Counsel on proper timing (within 30 minutes of bedtime) and avoidance of high-fat meals.
During treatment
- Monitor for treatment response within 7 to 10 days; if no improvement, re-evaluate for underlying condition.
- Watch for signs of complex sleep behaviors, worsening depression, suicidal ideation, or allergic reactions.
- In patients with liver disease, monitor based on clinician judgment.
Storage
Store at 25°C (77°F); excursions are permitted between 15–30°C (59–86°F). Keep the container tightly closed and protected from moisture and humidity, and keep it out of reach of children.
Study the drug class: Z-drugs and other hypnotics
Professional information
Clinician-facing context only. Use the current local prescribing information and guidelines for the management of insomnia.
United States
Indication: Insomnia with difficulty with sleep onset
Dose summary: 8 mg taken orally once nightly within 30 minutes before bedtime.
Renal context: No specific renal impairment dosing information is provided. (1)
Hepatic guidance
Use with caution in moderate hepatic impairment; not recommended in severe impairment.
Overdose note
No specific antidote; manage with supportive care and monitoring. Consider contacting a poison center. (1)
Frequently asked questions
Can I take ramelteon with food?
Do not take ramelteon with or immediately after a high-fat meal, as it may reduce the medicine's effectiveness. It can be taken on an empty stomach or after a light snack. (1)
Can I drive after taking ramelteon?
No, avoid driving or operating machinery for several hours after taking ramelteon because it can impair your concentration and coordination. (1)
What should I do if I experience complex sleep behaviors?
Report them to your prescriber immediately. The prescriber will assess the situation and decide whether you should continue taking ramelteon. (1)
What is the mechanism of action of ramelteon?
Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors, thought to support sleep onset. (1)
What is the generic name of Ramelteon?
The generic name is ramelteon. It is sold under brand names including ROZEREM. (1)
What class of drug is ramelteon?
Ramelteon is classed as: Melatonin receptor agonist. (1)
References
- ROZEREM (ramelteon) tablets, for oral useU.S. Food and Drug Administration (via DailyMed, National Library of Medicine) · United States · dated 2026-04 · accessed 2026-08-08 · source 1
- RAMELTEON TABLET [ADVANCED RX OF TENNESSEE, LLC] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 2
- Ramelteon — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 3
- Ramelteon — FDA approval record (Drugs@FDA ANDA215435)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 4
- ramelteon — RxNorm normalized drug concept (RXCUI 596205)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient ramelteon names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Rozerem8 mg · takeda pharmaceuticals america, inc.