ramelteon

Adjunctive therapy

Brands: ROZEREM

Last reviewed 2025-12-28

Reviewed by PsychMed Editorial Team.

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Quick answers

What is ramelteon?
Ramelteon (brand Rozerem) is a melatonin receptor agonist (MT1/MT2) approved for insomnia, primarily targeting sleep onset symptoms.
What is ROZEREM?
ROZEREM is a brand name for ramelteon.
What is ROZEREM (ramelteon) used for?
Label indications include: Insomnia (label).
What drug class is ROZEREM (ramelteon)?
Melatonin receptor agonist (MT1/MT2); hypnotic for sleep onset insomnia.
What strengths does ROZEREM (ramelteon) come in?
Tablets: 8 mg.

Snapshot

Class: Adjunctive therapy
Common US brands: ROZEREM
Therapeutic drug monitoring not routinely recommended.
Last reviewed: 2025-12-28

Label indications

Insomnia (label).

View labelExact

Clinical Highlights

Ramelteon (brand Rozerem) is a melatonin receptor agonist (MT1/MT2) approved for insomnia, primarily targeting sleep onset symptoms. It is not a controlled substance and is generally considered to have a low misuse potential, which can be useful when substance use risk makes sedative-hypnotics undesirable.

Effect size is often modest; set expectations, pair with CBT-I and sleep hygiene, and reassess benefit rather than escalating to polypharmacy.
Ramelteon is typically a better fit for sleep-onset complaints than for frequent nighttime awakenings; if sleep maintenance is the primary issue, consider alternative strategies rather than dose escalation.
The compare view and the ramelteon evidence feed can help weigh alternatives, and the ramelteon print page can support safety counseling.
Approved for insomnia (primarily sleep-onset complaints); when sleep maintenance is the main issue, consider alternative strategies rather than dose escalation.
Generic formulations are available; benefit is often modest, so reassess within a few weeks and avoid “polypharmacy creep” if response is limited.

Dosing & Formulations

Tablets: 8 mg. Take 8 mg within 30 minutes of bedtime; avoid taking with or immediately after a high-fat meal (delays onset).

There is no evidence-based benefit to taking more than the labeled dose; when response is inadequate, reassess diagnosis and nonpharmacologic interventions rather than increasing dose.
Avoid alcohol and other sedatives when possible; counsel about next-day impairment in sensitive patients.

Monitoring & Risks

Somnolence and dizziness can occur; assess driving/fall risk, especially in older adults and with polypharmacy. Hypersensitivity reactions (including angioedema) are rare but serious—discontinue and avoid rechallenge if they occur (label).

Monitor mood and suicidality in patients with depression, especially when insomnia is part of a mood episode.

Drug Interactions

Avoid combination with fluvoxamine (strong CYP1A2 inhibitor) due to marked exposure increase (label). CYP3A4 and CYP2C9 inhibitors can increase exposure; strong enzyme inducers (e.g., rifampin) can reduce effect (label).

Use caution with additive CNS depressants even though ramelteon is not a GABAergic hypnotic; combined sedative burden can still increase fall and driving risk.

Practice Notes

Favor CBT-I first; consider ramelteon when sleep-onset insomnia is the main symptom and a non-controlled option is preferred. Reassess response within a few weeks and avoid layering multiple sedatives when insomnia is driven by untreated mood, substances, pain, or sleep apnea.

If comorbid depression or anxiety is driving insomnia, treat the primary mood disorder (and address alcohol/cannabis use) rather than relying on hypnotic polypharmacy.
Use a short trial with a simple metric (sleep latency and next-day alertness); if benefit is minimal, stop and pivot rather than adding additional hypnotics.

References

Rozerem (ramelteon) prescribing information — DailyMed (2025)
Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline — Journal of Clinical Sleep Medicine (2017)
Efficacy and Acceptability of Pharmacological Interventions for Insomnia in Patients With Severe Mental Illness — Acta Psychiatrica Scandinavica (2025)
Residual effects of medications for sleep disorders on driving performance — European Neuropsychopharmacology (2024)