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Ramelteon

Ramelda, Rozerest · ATC code N05CH02

Key facts
Active substance
Ramelteon
Drug class
Melatonin receptor agonist
ATC code
N05CH02
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Ramelteon is a melatonin receptor agonist hypnotic. Per the US prescribing information, it is used to treat insomnia characterized by difficulty with sleep onset.

What it is used for

  • Insomnia characterized by difficulty falling asleep

Dosing

  • 8 mg taken within 30 minutes of going to bed
  • Should not be taken with or immediately after a high-fat meal
  • The total dose should not exceed 8 mg per day
  • Not recommended in severe hepatic impairment; caution in moderate hepatic impairment
  • Do not combine with fluvoxamine; caution with other CYP1A2 inhibitors

Contraindications

  • Angioedema after previous ramelteon treatment (no rechallenge)
  • Concomitant use of fluvoxamine

Important warnings

  • Rare angioedema of the tongue, glottis or larynx and anaphylaxis; airway obstruction can be fatal
  • Insomnia that does not remit after 7 to 10 days may indicate an underlying psychiatric or medical illness
  • Abnormal thinking and behavior changes, hallucinations, complex behaviors; worsening of depression including suicidal ideation
  • CNS effects: avoid hazardous activities after taking it; avoid alcohol
  • Effects on reproductive hormones (decreased testosterone, increased prolactin); not recommended in severe sleep apnea

Side effects

  • Somnolence, fatigue, nausea and exacerbated insomnia (3% each) and dizziness (4%) in placebo-controlled trials
  • Serious: angioedema, anaphylactic reactions, abnormal behavior

Interactions

  • Fluvoxamine (strong CYP1A2 inhibitor): exposure increased approximately 190-fold – contraindicated
  • Rifampin and other strong inducers: exposure reduced by about 80%, efficacy may be reduced
  • Ketoconazole (CYP3A4) and fluconazole (CYP2C9): increased exposure – use with caution
  • Alcohol: additive effect

Pregnancy and breastfeeding

  • Postmarketing data have not identified a drug-associated risk of major birth defects or miscarriage; animal studies showed developmental toxicity at high doses

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Turkey

  • RameldaABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • RozerestPHARMA PLANT İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

USA

  • RozeremTakeda Pharmaceuticals America, Inc. · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. Ramelteon (AvPAK) – Prescribing Information, 2026-05-27. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5245f9ee-b4ca-24b6-e063-6394a90a0b1b
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  4. Wikidata (CC0): ATC N05CH.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.