Ramelteon
ROZEREM
Pronunciation: ram-EL-tee-on (roe-ZAIR-em)
“Ram melty on Rose”
What it isMT1 and MT2 melatonin-receptor agonist; sleep-onset insomnia.
Why this oneIt is unscheduled and has no meaningful abuse or withdrawal liability, unlike benzodiazepine-site hypnotics.
What limits itEffect on sleep onset is modest. Strong CYP1A2 inhibition, especially fluvoxamine, can raise exposure markedly.
FDA-approved for
- insomnia (2005)
Off-label
- delirium prevention (limited evidence)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Insomnia (sleep-onset) | Adults | 8 mg QHS | 8 mg QHS | 8 mg/day |
Renal No adjustment needed
Hepatic Caution in moderate impairment; not recommended in severe
Instructions
- Take within 30 min of bedtime
- Do not take with or immediately after a high-fat meal
- Do not use with fluvoxamine; caution with other CYP1A2 inhibitors
- Reevaluate if insomnia persists after 7-10 days
Available strengths
- tab 8 mg
Contraindications
- History of angioedema with prior ramelteon; do not rechallenge
Cautions
- Angioedema/anaphylaxis (do not rechallenge)
- Abnormal thinking, complex sleep behaviors (sleep-driving, hallucinations)
- Worsening depression / suicidal ideation
- CNS impairment (driving, machinery)
- Decreased testosterone, increased prolactin
- Not recommended in severe sleep apnea
Adverse reactions
- Somnolence
- Dizziness
- Fatigue
- Nausea
- Exacerbated insomnia
Pregnancy No drug-associated risk identified in postmarketing data; teratogenic in rats at high multiples
Lactation Undefined
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 8 mg | tab | 30 qd | $19.79 | offered |
Generic entry2013
NO BOXED WARNINGS
Principal riskModest effect; contraindicated with fluvoxamine
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilitySomnolence and dizziness; overdose is generally less dangerous than sedative-hypnotics.
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