PEDEvidence

Ramelteon (Rozerem)

What it is & what research shows

Study example available

Ramelteon acts at MT1 and MT2 melatonin receptors and is studied for difficulty falling asleep. It is a distinct medicine, not a melatonin supplement. 451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months. [1.1]

Selected human research: 451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months. Laboratory-measured sleep onset improved at every reported treatment assessment. Patient-reported sleep onset improved at week 1, month 1 and month 5, but was not statistically significant at months 3 and 6. Most adverse events were mild or moderate. Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users. This is a selected trial summary, not a full literature review or formal quality appraisal. [2.1]

Studied methods, not dosing advice. Selected evidence, not a complete literature review or formal quality appraisal.
Sources & reading scope

Study-summary coverage

No completed study summaries are linked to this compound page yet. This is a coverage gap on PED Evidence, not evidence that human studies or other research do not exist.

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Selected study reading notes

Source-linked summaries with studied methods. These are separate from the automated summary counts above and are not formal quality appraisals.

Human

Ramelteon: what did the insomnia trial show?

451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months.

Demonstrated findings

Laboratory-measured sleep onset improved at every reported treatment assessment. Patient-reported sleep onset improved at week 1, month 1 and month 5, but was not statistically significant at months 3 and 6. Most adverse events were mild or moderate.

Limitations & adverse findings

Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users.

What might this mean? · interpretation

These results apply to the studied population, formulation and follow-up.

What might this mean, and what would change the interpretation?

This is a selected trial summary, not a full literature review or formal quality appraisal.

What would clarify this: Further studies of long-term outcomes and different patient groups.

Findings reviewed · abstract

Checked Sep 23, 2026 against the linked abstract. This reading note is not a formal risk-of-bias appraisal.

More about Ramelteon: identity, safety & reference details
Small moleculeSleep & insomnia
Primary research area
Sleep · insomnia
Regulatory status
See formulation-specific sources
Evidence level
Human randomized trials
Primary mechanism
Melatonin receptor agonist
Reference profile available · Coverage varies by section

Also known as Rozerem

What has been observed?

Selected source-linked reading notes, not the complete literature or a pooled conclusion.

Human · Abstract reviewed

Ramelteon: what did the insomnia trial show?

451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months.

Laboratory-measured sleep onset improved at every reported treatment assessment. Patient-reported sleep onset improved at week 1, month 1 and month 5, but was not statistically significant at months 3 and 6. Most adverse events were mild or moderate.

Limits & adverse findings: This is a selected trial summary, not a full literature review or formal quality appraisal. Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users.

Open primary source · Read interpretation separately
Explore outcomes for this compound
Uses & research

451 adults with chronic primary insomnia were randomized to ramelteon 8 mg or placebo, 30 minutes before bedtime nightly for six months. [1]

Known half-life

No source-verified value in this profile yet. A treatment schedule or duration of an effect is not a drug half-life.

Half-life describes how quickly the measured drug concentration falls by half. It does not set a dosing interval.
Evidence & important limits

Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users. [1]

Safety & evidence boundaries

Source-specific information, not a personal safety clearance or monitoring plan.

Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users.

Human study: Objective and subjective findings differed. No next-morning residual effects, rebound or withdrawal were detected in this trial; that does not establish their absence in all users. Source

Explore safety questions by system

These are literature filters, not claims that this compound causes each effect. A keyword match is not a confirmed adverse reaction.

Interactions, rare harms, long-term effects and reversibility require separate evidence. Do not infer they are absent when the sources here do not address them.

Identity, names & formulations

Canonical compound: Ramelteon · ramelteon

Searchable names: Rozerem

Names share a parent research page. Different esters, salts, routes and brands are not assumed to have the same half-life, indication or exposure.

Combination evidence stays attached to the studied combination. It is not automatically assigned to each ingredient.

Understand the evidence types

Read the model and design first, then the population, outcome and limitations. These categories describe evidence, not a best-compound ranking.

Randomized human trials
Compare assigned interventions. Randomization does not by itself establish low bias or relevance to every population.
Controlled human studies
Use a comparison group; allocation and confounding still matter.
Prospective human research
Follows participants forward. It may be observational or interventional, so this is not a separate quality grade.
Observational human research
Describes associations. Confounding can explain differences.
Case reports and series
Useful for unusual events and safety signals, not reliable rates or effect sizes.
Animal research
Can test biology and function in a living model. Human exposure, benefit and safety remain separate questions.
Cell and tissue research
Tests responses in a preparation, including human-derived cells. It is not a human participant trial.
Mechanistic and computational evidence
Helps explain or predict a pathway; predictions need experimental and clinical testing.
Anecdotal reports
Self-reported experiences can generate questions. Product identity, selection bias and other interventions may be uncontrolled.

Systematic reviews synthesize studies and depend on their quality. Preprint status and abstract versus full-paper reading are separate labels. Citation popularity measures attention, not reliability. A study summary is not a formal quality appraisal.

Sources for this profile

  1. 1. Six-month nightly ramelteon trial in chronic primary insomnia Human randomized trial · abstract

Reference facts checked 2026-09-23. Source scope is listed above; this is not a formal quality appraisal. See each label for full prescribing information.

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Study model describes the source. Confidence depends on methods, replication, population and outcome.

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