This page shows what was measured, who it was measured in, and what that does not settle.
What Ramelteon does in the body
Insomnia characterized by difficulty with sleep onset
From the FDA-approved label: Ramelteon is a melatonin receptor agonist with both high affinity for melatonin MT 1 and MT 2 receptors and relative selectivity over the MT 3 receptor. The activity of ramelteon at the MT 1 and MT 2 receptors is believed to contribute to its sleep- promoting properties, as these receptors, acted upon by endogenous melatonin, are thought to be involved in the maintenance of the circadian rhythm underlying the normal sleep-wake cycle. Ramelteon has no appreciable affinity for the GABA receptor complex or for receptors that bind neuropeptides, cytokines, serotonin, dopamine, noradrenaline, acetylcholine, and opiates.
What happened in people
RNAWiki has not yet published a reviewed conclusion for this use.
§ A fixed RNAWiki sentence
Where this came from
Wording RNAWiki always uses, not a finding about this substance.
No reviewed claim names a result for any goal on this record.
No source is stored against this line.
The limit that matters most
Not recorded.
Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 901AS54I69 · read 2026-08-29
Its recorded molecular formula is C16H21NO2, weighing 259.34.
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
Where each sentence above came from
No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.
Shown as the opening line on this page.
No statement of the main limit is recorded.
The four opening statements run to 119 words.
Words this page uses
Four words worth knowing first
Chosen from what this page shows, with each one explained before the word it depends on.
Stand-in result
A stand-in result is a number measured because the real result takes too long.
A picture of it, and where the picture fails
It is like judging a journey by the speedometer rather than by arriving.
Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.
What people get wrong. A stand-in result is often reported as the result itself.
A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
Receptor
A receptor is a part of a cell that a signal fits into.
A picture of it, and where the picture fails
A receptor is like a lock waiting for one key.
Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.
What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.
A protein that binds a specific ligand and converts that binding into a cellular response.
Pathway
A pathway is a chain of steps inside a cell, each one setting off the next.
A picture of it, and where the picture fails
A pathway is like a row of dominoes.
Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.
What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.
An ordered series of molecular interactions producing a defined cellular change.
What happened in people◇Read from sources, not yet reviewed
What was measured, goal by goal
One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.
Registered studies list 36 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.
There is no single score. A strong test result and a weak life result are different facts.
Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Sleep
∅Nothing in the sources checkedNo registered study lists a life outcome for this goal.
∅Nothing in the sources checkedNo registered study lists a performance measure for this goal.
…Waiting for a reviewer5 registered symptom measure.
∅Nothing in the sources checkedNo registered study lists a test result for this goal.
∅Nothing in the sources checkedNo registered study lists a body-step measure for this goal.
—Not recordedHarms were not a registered measure for this goal.
—Not recordedNo finished study window is recorded.
…Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Sleep
sleep efficiency; pittsburgh sleep quality index; latency to persistent sleep; latency to persistent sleep via polysomnography; insomnia severity index; sleep onset latency; sleep quality; efficacy of insomnia treatment on blood pressure
Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.
What each mark on this table means
∅ Nothing in the sources checked
No registered study lists a life outcome for this goal.
… Waiting for a reviewer
5 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
What happened in people◇Read from sources, not yet reviewed
What happened in people
Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.
Clinical Outcomes: Proportion of hospitalizations with any adverse event
✗ The study did not show it
Who was studied
NCT02969343
How many people
21000
Study design
Not applicable
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Adverse Events.
✗ The study did not show it
Who was studied
NCT00671086
How many people
1213
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Mean Subjective Sleep Latency determined through subject responses on morning questionnaire.
✗ The study did not show it
Who was studied
NCT00672724
How many people
1081
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind treatment.
✗ The study did not show it
Who was studied
NCT00671567
How many people
848
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Mean Subjective Sleep Latency per subject diary, from Nights 1 through 7 of double-blind Treatment
✗ The study did not show it
Who was studied
NCT00671255
How many people
829
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
Time From Randomization to Any Relapse
✗ The study did not show it
Who was studied
NCT01467713
How many people
642
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route. Oral
Interval reported. Not recorded in this summary
Written into the record, not signed off as a reviewed claim.
openFDA Drugs@FDA · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
openFDA SPL label · a recorded source, not a stored snapshot
PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.
What happened in people◇Read from sources, not yet reviewed
How close this is to real life
The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.
□Living longer, or avoiding a major eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.5 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.2 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□A guess from softwareNo evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.
Higher on these steps means closer to something a person would feel. It does not mean better done.
What it would be like to take◇Read from sources, not yet reviewed
Felt, measured, or meaningful
Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.
Felt
Things a person could notice without a test.
pittsburgh sleep quality index
insomnia severity index
sleep quality
efficacy of insomnia treatment on blood pressure
insomnia severity index scores
Measured
Things only a test, a scale or a device shows.
waist circumference
maximum observed serum concentration
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.
Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.
Measured, but not felt. A number moves. The person notices nothing. Both can be true.
Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.
Matters, but takes years. The result that counts may take longer than anyone would keep watching.
Names that fit none of the three (29)
standard deviation of speed
sleep efficiency
epworth sleepiness scale
who discontinued zolpidem therapy
polysomnography data
sensory organization test composite
remitters on ids c30 at week 12
adverse events
vital signs
electrocardiograms
physical examinations
latency to persistent sleep
central apnea index
latency to persistent sleep via polysomnography
non usable and poor quality psgs and cpap intolerance
marijuana withdrawal
terminal elimination rate constant
terminal elimination half life
apparent volume of distribution
sleep onset latency
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What it would be like to take◇Read from sources, not yet reviewed
How long anything takes
Nine different lengths of time that get confused with each other. None of them is worked out from another.
Before anything is noticed.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before a test result moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
Before performance moves.RNAWiki does not store this separately, and never works it out from another figure on this page.
How long the result was watched.No finished study window is recorded for a study that tested this substance.
How long people took it.How long people actually took it is not stored. The study window is not the same thing.
How long people were followed.Follow-up length is not stored separately. It is never read off the study window, which would be a different thing.
How fast the body clears it. 2.6 hours hours
Read from the label, which states: “Repeated once daily dosing with ramelteon does not result in significant accumulation owing to the short elimination half-life of ramelteon (on average, approximately one to 2.6 hours).”
How long effects linger.RNAWiki does not store this separately, and never works it out from another figure on this page.
Beyond the studies. Nothing is recorded about the long term.
The longest finished study sets the edge of what anyone measured.
A study window is not how long people took it, and neither is how long they were followed. Where RNAWiki holds only one of the three, it shows one.
What is missing or unclear◇Read from sources, not yet reviewed
Were people like you studied?
RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.
Who was studied
People similar to this profile were included.
I NDICATIONS AND USAGE Ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset. The clinical trials performed in support of efficacy were up to six months in duration.
Who is missing from the studies
Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What the label states about particular groups
On pediatric, the label states: “Safety and effectiveness of ramelteon in pediatric patients have not been established.”
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
On older people, the label states: “A total of 654 subjects in double-blind, placebo-controlled, efficacy trials who received ramelteon were at least 65 years of age; of these, 199 were 75 years of age or older.”
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary Available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data regarding the presence of ramelteon or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production.”
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
On people with reduced liver function, the label states: “Exposure to ramelteon was increased by four-fold in subjects with mild hepatic impairment and by more than ten-fold in subjects with moderate hepatic impairment.”
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
On people with reduced kidney function, the label states: “No effects on C max and AUC 0-t of parent drug or M-II were seen.”
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
Where the result stopped carrying
This is a scope explorer, not a diagnosis engine.
It shows who was studied so you can see whether people similar to you were included.
RNAWiki cannot tell whether a study fits you. It can show who was in it.
What it would be like to take◇Read from sources, not yet reviewed
Why it might seem to do nothing
A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.
It was studied for a different goal
The studies measured something else entirely.
On this record: Some registered studies measured things that match no goal on this page.
It was studied in different people
The people in the studies were not much like the reader.
On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
The evidence may simply be wrong
Small early studies often do not hold up.
On this record: RNAWiki has not yet published a reviewed conclusion for this use.
Other reasons RNAWiki checked and found nothing for (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.
None of these is a reason to take more. Taking more is not a step this page ever suggests.
What it would be like to take◇Read from sources, not yet reviewed
What taking it involves
The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.
How it is supplied
Prescription only
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
Read from the recorded approval status.
No source is stored against this line.
Form and route
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form and route recorded on this substance.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Sold as tablet, tablet, film coated, given by the oral route.
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
Recorded notes on how this is sold and what that means for what is in the pack.
No source is stored against this line.
Where it is registered
Regulatory records are listed in the technical disclosure at the foot of this page.
# Counted from records
Where this came from
A count of rows RNAWiki holds. It describes our records, not your body.
Register entries are stored per jurisdiction and shown with their dates.
No source is stored against this line.
Why people stop
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No record of why people stopped taking it is stored for this substance.
No source is stored against this line.
What it would be like to take∅Nothing found in the sources checked
What can go wrong
Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.
∅Nothing found in the sources checked
No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.
The sources listed were searched and held nothing. That is not the same as nothing existing.
Reports sent to a regulator
These are reports people sent to a regulator. They do not show the medicine caused the reaction.
Nobody counted how many people took the medicine and reported nothing.
The same event can be reported more than once, and many reports are incomplete.
News coverage, lawsuits and new warnings change how often people report.
A count is not a rate and not a risk.
Ramelteon appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 673 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
somnolence — 120 reaction mentions
nightmare — 81 reaction mentions
insomnia — 71 reaction mentions
initial insomnia — 68 reaction mentions
abnormal dreams — 67 reaction mentions
middle insomnia — 67 reaction mentions
feeling abnormal — 58 reaction mentions
poor quality sleep — 53 reaction mentions
anxiety — 47 reaction mentions
hallucination — 41 reaction mentions
open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot
Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.
Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.
What is missing or unclear◇Read from sources, not yet reviewed
Does the exact form matter?
Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.
The form that was studied
Oral
✎ Source-linked record
Where this came from
A person wrote this into the record with the study named beside it. No reviewer has signed it off.
The form used in the studies cited on this page.
No source is stored against this line.
What is sold
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing further is recorded about which forms are sold.
No source is stored against this line.
What is recorded as being sold
54 products list this as an active ingredient in the United States drug directory. 54 of them contain it and nothing else.
FDA National Drug Code directory · 71335-2886 · read 2026-08-29
They are sold as powder, tablet and tablet, film coated, taken oral.
FDA National Drug Code directory · 71335-2886 · read 2026-08-29
The regulator's established pharmacologic class for it is melatonin receptor agonist [epc] and melatonin receptor agonists [moa].
FDA National Drug Code directory · 71335-2886 · read 2026-08-29
41 published labels name it as an active ingredient. 41 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-29
Ramelteon is oral at 3 DOSAGE FORMS AND STRENGTHS Ramelteon tablets are available in an 8 mg strength tablet for oral administration., recorded as fda label in effect 2024-12-31 in the United States.
US prescribing information · fe2fc3b7-4600-c14e-e053-6394a90a2586 · read 2026-08-30
Recorded price in US: 0.65749 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 19 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read from sources, not yet reviewed
What you could measure
This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Ramelteon studied people like me?
What was measured, and for how long?
Was the result a laboratory value or a health outcome?
What would we watch for, and when would we stop?
Tracking can show whether something changed for you. It cannot show what caused it.
RNAWiki records evidence. It does not say whether this substance is right for you.
What is missing or unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
Missing populations
Which groups were under-represented in the studies has not been recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing long-term data
No completed tested study window is recorded.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
No reviewed conclusion
RNAWiki has not yet published a reviewed conclusion for this use.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Missing interaction studies
No interaction was found in the registers checked. Not finding one is not the same as showing there is none.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
Formulation uncertainty
Several salts, forms or products of Ramelteon are recorded. Results from one form may not transfer to another.
Why it matters. Recorded by the evidence model as a gap on this record.
What would answer it
A study that measures it, and a reviewer to sign it off.
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A study that measures it, and a reviewer to sign it off.
Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.
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Check any of this yourself
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RNAWiki source record
40 of them state the same halfLife, and they agree.
RNAWiki source record
40 of them state the same bioavailability, and they agree.
RNAWiki source record
40 of them state the same tMax, and they agree.
RNAWiki source record
40 of them state the same proteinBinding, and they agree.
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Where else this substance is registered
FDA substance identifier (UNII)
901AS54I69
RxNorm concept
577348
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12 approved applications cover products containing this substance. The earliest was NDA021782, approved 20050722 to TAKEDA PHARMS USA.
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5 questions this page could not answer
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Recorded evidence blocks (14)
Q1
What did Ramelteon's largest trial (3339 people) and its longest (6.8 years) measure?
3339 people in Ramelteon's largest registered study, 6.8 years in its longest registered window, measuring Maximum Observed Serum Concentration (Cmax). ClinicalTrials.gov · 2026-09-01
30 phase4, 19 phase3, 14 phase2, 6 na, 3 phase1, 2 na or unstated; NCT02691013; 2022-12-01; no ageing endpoint recorded. Last human test completed 2025, NCT07382843.
Interpretation These counts include studies where Ramelteon was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.
Show the evidence
phase4
30
phase3
19
phase2
14
na
6
phase1
3
na or unstated
2
1 more recorded row
Last recorded human testNCT07382843
2025-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q2
From mouse to human: where has Ramelteon shown lifespan?
5 recorded entries; human; also "Rozerem 8mg", "Rozerem 8mg in combination with Multi Component Behavior Therapy", "Rozerem 8 mg Tablets"
Show the evidence
human
NCT00319215
Ramelteon 8 mg
NCT01180855
Rozerem 8mg
NCT01180855
Rozerem 8mg in combination with Multi Component Behavior Therapy
NCT02153086
Rozerem 8 mg Tablets
NCT03461042
Ramelteon 8mg
recorded 2026-09-01 · last checked 2026-09-04
Q5
Ramelteon's half-life is 2.6 hours — which schedules were studied?
2.6 hours, the half-life Ramelteon's label states. openfda-label · 57b24572-f601-b092-e063-6394a90afa53 · 2026-08-30
bioavailability 1.8% %.
Show the evidence
half life
2.6 hours hours; Repeated once daily dosing with ramelteon does not result in significant accumulation owing to the short elimination half-life of ramelteon (on average, approximately one to 2.6 hours).
tmax
Median T max was delayed by approximately 45 minutes when ramelteon tablets were administered with food.
bioavailability
1.8% %; Although the total absorption of ramelteon is at least 84%, the absolute oral bioavailability is only 1.8% due to extensive first-pass metabolism.
metabolism
When administered orally to humans in doses ranging from 4 to 64 mg, ramelteon undergoes rapid, high first-pass metabolism, and exhibits linear pharmacokinetics.
recorded 2026-08-30 · last checked 2026-09-04
Q6
Could one person measure Ramelteon's effect on standard deviation of speed?
Standard deviation of speed: measured in Ramelteon's trials.
Interpretation standard deviation of speed is the recorded endpoint.
Show the evidence
biomarkers
standard deviation of speed; 2026-09-01
sleep efficiency; 2026-09-01
epworth sleepiness scale; 2026-09-01
who discontinued zolpidem therapy; 2026-09-01
polysomnography data; 2026-09-01
sensory organization test composite; 2026-09-01
14 more recorded rows
biomarkers
pittsburgh sleep quality index; 2026-09-01
biomarkers
waist circumference; 2026-09-01
biomarkers
remitters on ids c30 at week 12; 2026-09-01
biomarkers
adverse events; 2026-09-01
biomarkers
vital signs; 2026-09-01
biomarkers
electrocardiograms; 2026-09-01
biomarkers
physical examinations; 2026-09-01
biomarkers
latency to persistent sleep; 2026-09-01
biomarkers
central apnea index; 2026-09-01
biomarkers
latency to persistent sleep via polysomnography; 2026-09-01
biomarkers
non usable and poor quality psgs and cpap intolerance; 2026-09-01
0; NCT00907595; NA; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q7
Which of adverse events, apparent volume of distribution and central apnea index did Ramelteon's trials measure?
adverse events, apparent volume of distribution and central apnea index lead 36 outcome terms across Ramelteon's trials. ClinicalTrials.gov · 2026-09-01
who discontinued zolpidem therapy, polysomnography data, sensory organization test composite, pittsburgh sleep quality index, waist circumference and remitters on ids c30 at week 12 follow.
Show the evidence
standard deviation of speed
1
sleep efficiency
1
epworth sleepiness scale
1
who discontinued zolpidem therapy
1
polysomnography data
1
sensory organization test composite
1
14 more recorded rows
pittsburgh sleep quality index
1
waist circumference
1
remitters on ids c30 at week 12
1
adverse events
1
vital signs
1
electrocardiograms
1
physical examinations
1
latency to persistent sleep
1
central apnea index
1
latency to persistent sleep via polysomnography
1
non usable and poor quality psgs and cpap intolerance
1
insomnia severity index
1
marijuana withdrawal
1
maximum observed serum concentration
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Ramelteon's 2 ongoing trials reports first?
Mean Latency to Persistent Sleep Assessed by Polysomnography; Insomnia Severity Index (ISI) scores (sleep quality); latest 2028-06
Show the evidence
Trial
NCT06512363
"A Study of Ramelteon in Chinese Patients With Chronic Insomnia"; n 280; "Mean Latency to Persistent Sleep Assessed by Polysomnography"; 2026-12
NCT07598734
"Doxepin Alone or Combined With Ramelteon Versus Placebo for Improving Sleep Quality After Primary Total Knee Arthroplasty"; n 129; "Insomnia Severity Index (ISI) scores (sleep quality)"; 2028-06
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 27 trials of Ramelteon posted no result?
Posted no result
27 of 27 completed trials
Registrations
NCT00671398, NCT00671294, NCT00671125, NCT00671567, NCT00671632 and NCT00672061, and 21 more
Completion dates
oldest 2003-05; newest 2022-02-01
Show the evidence
Trial
NCT00671398
2003-05
NCT00671294
2003-07
NCT00671125
2003-09
NCT00671567
2003-09
NCT00671632
2003-12
NCT00672061
2003-12
14 further recorded trials
NCT00915135
2003-12
NCT00671255
2004-01
NCT00672802
2004-03
NCT00656994
2004-07
NCT00671086
2004-09
NCT00671190
2005-05
NCT00319215
2006-07
NCT00568789
2006-09
NCT00755508
2006-09
NCT00237497
2006-10
NCT00316992
2006-11
NCT00247390
2006-12
NCT00755495
2007-03
NCT00492011
2007-08
Q10
At the median, Ramelteon's trials enrolled 58.5 people — anything larger?
Median enrolment
58.5
Largest enrolment
3339
Registered trials counted
74
Q11
What do 673 spontaneous reports say about Ramelteon — and not say?
These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.
Ramelteon appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 673 reaction mentions were counted: somnolence 120; nightmare 81; insomnia 71; initial insomnia 68. open-targets-adr · CHEMBL1218 · 2026-06-24
Show the evidence
somnolence
120
nightmare
81
insomnia
71
initial insomnia
68
abnormal dreams
67
middle insomnia
67
4 more recorded rows
feeling abnormal
58
poor quality sleep
53
anxiety
47
hallucination
41
recorded 2026-06-24 · last checked 2026-09-04
Q12
Ramelteon and CYP1A2, CYP3A4 and CYP2C9: shared by which compounds?
CYP1A2, CYP3A4 and CYP2C9 appear in Ramelteon's recorded interaction sentences, 14 in all. openfda-label+europepmc · 2026-08-30
CYP1A2 is the major isozyme involved in the hepatic metabolism of ramelteon; the CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree.
clinical_pharmacology
As noted above, CYP1A2 is the major isozyme involved in the metabolism of ramelteon; the CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree.
clinical_pharmacology
Interaction studies of concomitant administration of ramelteon with fluoxetine (CYP2D6 inhibitor), omeprazole (CYP1A2 inducer/CYP2C19 inhibitor), theophylline (CYP1A2 substrate), dextromethorphan (CYP2D6 substrate), sertraline, venlafaxine, escitalopram, gabapentin, and zolpidem did not produce clinically meaningful changes in either peak or total exposures to ramelteon or the M-II metabolite.
clinical_pharmacology
Effects of Other Drugs on Ramelteon Metabolism Fluvoxamine (strong CYP1A2 inhibitor) When fluvoxamine 100 mg twice daily was administered for three days prior to single-dose coadministration of ramelteon 16 mg and fluvoxamine, the AUC 0-inf for ramelteon increased approximately 190-fold, and the C max increased approximately 70-fold, compared to ramelteon administered alone.
clinical_pharmacology
Ramelteon should be administered with caution to patients taking less strong CYP1A2 inhibitors [see Contraindications (4) , Drug Interactions (7) ] .
clinical_pharmacology
Other less strong CYP1A2 inhibitors have not been adequately studied.
CYP2C19clinical_pharmacology
Interaction studies of concomitant administration of ramelteon with fluoxetine (CYP2D6 inhibitor), omeprazole (CYP1A2 inducer/CYP2C19 inhibitor), theophylline (CYP1A2 substrate), dextromethorphan (CYP2D6 substrate), sertraline, venlafaxine, escitalopram, gabapentin, and zolpidem did not produce clinically meaningful changes in either peak or total exposures to ramelteon or the M-II metabolite.
CYP2C9
clinical_pharmacology
Fluconazole (strong CYP2C9 inhibitor) The total and peak systemic exposure (AUC 0-inf and C max ) of ramelteon after a single 16 mg dose of ramelteon was increased by approximately 150% when administered with fluconazole.
clinical_pharmacology
Ramelteon should be administered with caution in subjects taking strong CYP2C9 inhibitors such as fluconazole [see Drug Interactions (7) ] .
CYP2D6clinical_pharmacology
Interaction studies of concomitant administration of ramelteon with fluoxetine (CYP2D6 inhibitor), omeprazole (CYP1A2 inducer/CYP2C19 inhibitor), theophylline (CYP1A2 substrate), dextromethorphan (CYP2D6 substrate), sertraline, venlafaxine, escitalopram, gabapentin, and zolpidem did not produce clinically meaningful changes in either peak or total exposures to ramelteon or the M-II metabolite.
CYP3A4
pharmacokinetics
CYP1A2 is the major isozyme involved in the hepatic metabolism of ramelteon; the CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree.
clinical_pharmacology
As noted above, CYP1A2 is the major isozyme involved in the metabolism of ramelteon; the CYP2C subfamily and CYP3A4 isozymes are also involved to a minor degree.
clinical_pharmacology
Ketoconazole (strong CYP3A4 inhibitor) The AUC 0-inf and C max of ramelteon increased by approximately 84% and 36%, respectively, when a single 16 mg dose of ramelteon was administered on the fourth day of ketoconazole 200 mg twice daily administration, compared to administration of ramelteon alone.
clinical_pharmacology
Ramelteon should be administered with caution in subjects taking strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions (7) ] .
recorded 2026-08-30 · last checked 2026-09-04
Q13
Was Ramelteon studied with fasting?
fasting is named in Ramelteon's label sentences: "Melatonin/ramelteon outperformed placebo on the primary outcome (SMD -0.28, 95% CI = -0.39 ÷ -0.168), as well as on all individual components of metabolic syndrome (systolic blood pressure MD -3.266, 95% CI = -6.020 ÷ -0.511; fasting glucose MD -3.766, 95% CI = -5.938 ÷ -1.593; triglycerides MD…" openfda-label+europepmc · 2026-08-30
1 recorded statement; fasting
Show the evidence
fasting
Melatonin/ramelteon outperformed placebo on the primary outcome (SMD -0.28, 95% CI = -0.39 ÷ -0.168), as well as on all individual components of metabolic syndrome (systolic blood pressure MD -3.266, 95% CI = -6.020 ÷ -0.511; fasting glucose MD -3.766, 95% CI = -5.938 ÷ -1.593; triglycerides MD -9.800, 95% CI = -19.431 ÷ -0.169; HDL MD 2.995, 95% CI = 0.567 ÷ 5.423), except waist circumference.
recorded 2026-08-30 · last checked 2026-09-04
Q14
What is recorded about Ramelteon and sirtuin?
"Therefore, we propose a hypothesis that ramelteon may exert cardioprotective effects by activating the Sirt3 signaling pathway." — where Ramelteon and sirtuin appear together. Europe PMC · pathway abstract search · 2024-02-07
"Therefore, we propose a hypothesis that ramelteon may exert cardioprotective effects by activating the Sirt3 signaling pathway."
PMID 38330708
"Our results showed that the activation levels and expression level of Sirt3 were significantly decreased in MIRI tissue and H<sub>2</sub>O<sub>2</sub> stimulated H9C2 cells, while ramelteon treatment upregulated Sirt3 activity and expression."
PMID 38330708
"The results showed that the myocardial protection and anti-apoptotic effects of ramelteon were antagonized by 3-TYP, indicating that the activation of Sirt3 is a key mechanism for ramelteon to exert myocardial protection."
mTORPMID 32107468
"We further revealed that ramelteon significantly inhibited autophagy in the peri-infarct cortex in both the mouse ischemia models via regulating AMPK/mTOR signaling pathway."
AMPKPMID 32107468
"We further revealed that ramelteon significantly inhibited autophagy in the peri-infarct cortex in both the mouse ischemia models via regulating AMPK/mTOR signaling pathway."
autophagy
PMID 32107468
"We further revealed that ramelteon significantly inhibited autophagy in the peri-infarct cortex in both the mouse ischemia models via regulating AMPK/mTOR signaling pathway."
PMID 32107468
"Intracerebroventricular injection of rapamycin, an autophagy activator, compromised the neuroprotection of ramelteon, suggesting ramelteon might attenuate ischemic injury by counteracting autophagic cell death."
recorded 2024-02-07 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work
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