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Eszopiclone

  • Prescription medicine
  • Prescription only
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Eszopiclone does in the body

Insomnia

From the FDA-approved label: The precise mechanism of action of eszopiclone as a hypnotic is unknown, but its effect is believed to result from its interaction with GABA-receptor complexes at binding domains located close to or allosterically coupled to benzodiazepine receptors. Eszopiclone is a nonbenzodiazepine hypnotic that is a pyrrolopyrazine derivative of the cyclopyrrolone class with a chemical structure unrelated to pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates, or other drugs with known hypnotic properties.

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
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · UZX80K71OE · read 2026-08-29

  • Its recorded molecular formula is C17H17CIN6O3, weighing 388.81.

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · 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 86 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 peopleRead 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 32 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.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
SleepNothing 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.
PainNothing 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 reviewer1 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.
EnergyNothing 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 reviewer1 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
pittsburgh sleep quality index; subjective wake time after sleep onset; wake after sleep onset; sleep latency; total sleep time; sleep efficiency; sleep quality; insomnia severity index
Pain
pain
Energy
fatigue

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 peopleRead 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.

Average of Subjective Sleep Latency

The study did not show it

Who was studied
NCT00352144
How many people
830
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

Average sleep latency over the last half of the double-blind study period ("last-three-month average" = mean of the monthly averages for months 4, 5, and 6)

The study did not show it

Who was studied
NCT01710631
How many people
791
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

The primary endpoint is the change from baseline in HAM-D-17 total score at Week 8.

The study did not show it

Who was studied
NCT00435279
How many people
678
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

Insomnia Severity Index

The study did not show it

Who was studied
NCT03668041
How many people
673
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 wake time after sleep onset (WASO)

The study did not show it

Who was studied
NCT00368030
How many people
545
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

Change From Baseline to the End of the Double- Blind Treatment Period (Week 12) in Polysomnography (PSG) Defined Latency to Persistent Sleep (LPS).

The study did not show it

Who was studied
NCT00856973
How many people
486
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 peopleRead 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.

  1. Living longer, or avoiding a major event No evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
  2. What a body can do day to day No evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
  3. Measured performance No evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.7 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.1 registered measure of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Rat. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No 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 takeRead 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
  • pain
  • sleep quality
  • insomnia severity index
  • fatigue
  • insomnia severity index from baseline
  • efficacy of insomnia treatment on blood pressure

Measured

Things only a test, a scale or a device shows.

  • pharmacokinetic parameter maximal drug 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 (24)
  • standard deviation of speed
  • subjective wake time after sleep onset
  • wake after sleep onset
  • sleep latency
  • awakenings
  • total sleep time
  • sleep efficiency
  • actigraphy
  • cordance value
  • latency to persistent sleep
  • standard deviation of lateral position
  • non usable and poor quality psgs and cpap intolerance
  • total sleep time from baseline to final visit
  • overall incidence of adverse events
  • marijuana withdrawal
  • latency to persistent sleep measured by polysomnography
  • apnea hypopnea index
  • sleep spindle density
  • sleep onset latency
  • area under curve

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 takeRead 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.

  1. Before anything is noticed. RNAWiki does not store this separately, and never works it out from another figure on this page.

  2. Before a test result moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  3. Before performance moves. RNAWiki does not store this separately, and never works it out from another figure on this page.

  4. How long the result was watched. No finished study window is recorded for a study that tested this substance.

  5. How long people took it. How long people actually took it is not stored. The study window is not the same thing.

  6. 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.

  7. How fast the body clears it. 6 hours hours

    Read from the label, which states: “Eszopiclone is rapidly absorbed, with a time to peak concentration (t max ) of approximately 1 hour and a terminal-phase elimination half-life (t 1/2 ) of approximately 6 hours.”

  8. How long effects linger. RNAWiki does not store this separately, and never works it out from another figure on this page.

  9. 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 unclearRead 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.

  • & USAGE Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 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 eszopiclone have not been established in pediatric patients.”

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-30

  • On older people, the label states: “A total of 287 subjects in double-blind, parallel-group, placebo-controlled clinical trials who received eszopiclone were 65 to 86 years of age.”

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary Available pharmacovigilance data with eszopiclone use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.”

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-30

  • On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of eszopiclone in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.”

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-30

  • On people with reduced liver function, the label states: “No dose adjustment is necessary for patients with mild-to-moderate hepatic impairment.”

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · 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 takeRead 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 takeRead 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

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S6.

No source is stored against this line.

What is in the pack

Sold as tablet, tablet, film coated, tablet, coated, given by the oral, oropharyngeal 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 takeNothing 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.

Eszopiclone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1458 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • dysgeusia — 596 reaction mentions
  • insomnia — 375 reaction mentions
  • somnolence — 100 reaction mentions
  • suicide attempt — 92 reaction mentions
  • middle insomnia — 70 reaction mentions
  • amnesia — 56 reaction mentions
  • nightmare — 53 reaction mentions
  • initial insomnia — 44 reaction mentions
  • hallucination — 38 reaction mentions
  • paradoxical drug reaction — 34 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 unclearRead 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

  • 111 products list this as an active ingredient in the United States drug directory. 111 of them contain it and nothing else.

    FDA National Drug Code directory · 71335-9659 · read 2026-08-29

  • They are sold as powder, tablet, coated and tablet, film coated, taken oral and oropharyngeal.

    FDA National Drug Code directory · 71335-9659 · read 2026-08-29

  • 63 published labels name it as an active ingredient. 63 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-29

  • Eszopiclone is oral at 3 DOSAGE FORMS & STRENGTHS Eszopiclone tablets, USP are available in 1 mg, 2 mg and 3 mg strengths for oral administration., recorded as fda label in effect 2025-09-24 in the United States.

    US prescribing information · f6022b2f-9b43-40cc-91c7-c224b209efab · read 2026-08-30

  • Recorded price in US: 0.08581–0.09117 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 28 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 takeRead 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.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Eszopiclone 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 unclearRead 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 Eszopiclone 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.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

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.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

How many documents were read

  • 63 documents were read for this substance.

    RNAWiki source record

  • 63 of them state the same halfLife, and they agree.

    RNAWiki source record

  • 63 of them state the same tMax, and they agree.

    RNAWiki source record

  • 63 of them state the same proteinBinding, and they agree.

    RNAWiki source record

Where else this substance is registered

FDA substance identifier (UNII)
UZX80K71OE
RxNorm concept
485442

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

    No unresolved merge across substance families

    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

  • Passed

    No internal keys in reader text

    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S6.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 15 approved applications cover products containing this substance. The earliest was NDA021476, approved 20041215 to WAYLIS THERAP.

    Drugs@FDA application register · NDA021476 · read 2026-08-29

  • Marketing status on the register: discontinued and prescription.

    Drugs@FDA application register · NDA021476 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 20041215.

    FDA National Drug Code directory · 71335-9659 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

5 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • The path through the body — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (11)

What did Eszopiclone's largest trial (4876 people) and its longest (7.9 years) measure?


4876 people in Eszopiclone's largest registered study, 7.9 years in its longest registered window, measuring Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax). ClinicalTrials.gov · 2026-09-01

29 phase4, 19 phase3, 18 phase1, 15 na, 9 phase2, 4 na or unstated, 1 early phase1; NCT00374556; 2013-12; no ageing endpoint recorded. Last human test completed 2026, NCT03668041.

Interpretation These counts include studies where Eszopiclone 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
    29
  • phase3
    19
  • phase1
    18
  • na
    15
  • phase2
    9
  • na or unstated
    4
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT03668041
    2026-03-30

recorded 2026-09-01 · last checked 2026-09-04

From rat to human: where has Eszopiclone shown biomarker?


rat: mechanism-only and human: biomarker (93): the rungs where Eszopiclone has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Interpretation Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax) — the recorded outcome words.

Yeast C. elegans Drosophila Mouse Rat mechanism-onlyDog Non-human primate Human biomarker
Show the evidence
  • rat
    mechanism-only
  • human NCT01055834
    biomarker; Pharmacokinetic Parameter (Bioequivalence): Maximal Drug Concentration (Cmax); 93

recorded 2026-09-01 · last checked 2026-09-04

3 of Eszopiclone's trials stopped: accrual/recruitment, funding/business, other?


accrual/recruitment (1), funding/business (1) and other (1): Eszopiclone's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Funding terminated by sponsor, insufficient data collection"; 3 of 93 registered studies

Show the evidence

Trial

  • NCT00414037
    terminated; "Funding terminated by sponsor, insufficient data collection"
  • NCT00511134
    terminated; "Study has been terminated due low recruitment of participant population."
  • NCT00781482
    withdrawn; "Sponsor elected not to conduct study at this time."

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Eszopiclone used Zopiclone 7.5 mg — over how long?


studies of Eszopiclone used the recorded amount. ClinicalTrials.gov · 2026-09-01

11 recorded entries; human; tablet; also "Zopiclone 7.5 mg", "Lunesta 2 - 3 mg q HS", "Eszopiclone 1 mg"

Show the evidence

human

  • NCT00319215
    Zopiclone 7.5 mg
  • NCT00324896
    Lunesta 2 - 3 mg q HS
  • NCT00770510
    Eszopiclone 1 mg
  • NCT00770510
    Eszopiclone 2 mg
  • NCT00770510
    Eszopiclone 3 mg
  • NCT01710631
    eszopiclone 3 mg
5 more recorded rows
  • human NCT02322645
    Eszopiclone Tablets 3 mg
  • human NCT05277038
    tablet; Zopiclone 3.75mg tablet
  • human NCT05349396
    Eszopiclone 3mg Test Drug T-1 Coated Tablets
  • human NCT05349396
    Eszopiclone 3mg Test Drug T-2 Coated Tablets
  • human NCT05349396
    Eszopiclone 3mg Reference Product Coated Tablets

recorded 2026-09-01 · last checked 2026-09-04

Eszopiclone's half-life is 6 hours — which schedules were studied?


6 hours, the half-life Eszopiclone's label states. openfda-label · c4ff1d6a-918e-c046-e053-2a95a90a9c9b · 2026-08-30

Show the evidence
  • half life
    6 hours hours; Eszopiclone is rapidly absorbed, with a time to peak concentration (t max ) of approximately 1 hour and a terminal-phase elimination half-life (t 1/2 ) of approximately 6 hours.
  • tmax
    Eszopiclone is rapidly absorbed, with a time to peak concentration (t max ) of approximately 1 hour and a terminal-phase elimination half-life (t 1/2 ) of approximately 6 hours.
  • metabolism
    Metabolism Following oral administration, eszopiclone is extensively metabolized by oxidation and demethylation.

recorded 2026-08-30 · last checked 2026-09-04

Which of actigraphy, apnea hypopnea index and area under curve did Eszopiclone's trials measure?


actigraphy, apnea hypopnea index and area under curve lead 32 outcome terms across Eszopiclone's trials. ClinicalTrials.gov · 2026-09-01

Interpretation subjective wake time after sleep onset, wake after sleep onset, sleep latency, awakenings, total sleep time and sleep efficiency follow.

Show the evidence
  • pittsburgh sleep quality index
    1
  • standard deviation of speed
    1
  • pain
    1
  • subjective wake time after sleep onset
    1
  • wake after sleep onset
    1
  • sleep latency
    1
14 more recorded rows
  • awakenings
    1
  • total sleep time
    1
  • sleep efficiency
    1
  • sleep quality
    1
  • insomnia severity index
    1
  • actigraphy
    1
  • fatigue
    1
  • cordance value
    1
  • insomnia severity index from baseline
    1
  • latency to persistent sleep
    1
  • standard deviation of lateral position
    1
  • non usable and poor quality psgs and cpap intolerance
    1
  • total sleep time from baseline to final visit
    1
  • overall incidence of adverse events
    1

recorded 2026-09-01 · last checked 2026-09-04

Which of Eszopiclone's 4 ongoing trials reports first?


4 registered trials of Eszopiclone are open; earliest completion 2025-12-11. ClinicalTrials.gov · 2026-09-01

Sleep quality score, objective measurement using the validated Likert sleep scale; Change in OSA severity (eszopiclone and lemborexant night vs. placebo night); latest 2030-06

Show the evidence

Trial

  • NCT05618002
    "Lemborexant vs Zopiclone vs Clonidine for Insomnia Treatment in Chronic Pain Patients"; n 150; "Sleep quality score, objective measurement using the validated Likert sleep scale"; 2025-12-11
  • NCT06928766
    "Effects of Eszopiclone and Lemborexant in People With OSA With a Low Arousal Threshold Who Have Difficulty Sleeping"; n 15; "Change in OSA severity (eszopiclone and lemborexant night vs. placebo night)"; 2027-06-30
  • NCT07018557
    "Impact of Eszopiclone on Blood Pressure in Patients With Insomnia and Hypertension (PRYSMA-HTN)"; n 150; "Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)"; 2026-12-31
  • NCT07332442
    "Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep Apnea"; n 250; "CPAP adherence"; 2030-06

recorded 2026-09-01 · last checked 2026-09-04

Which 42 trials of Eszopiclone posted no result?


Posted no result
42 of 42 completed trials
Registrations
NCT01710631, NCT00685269, NCT00352144, NCT00368030, NCT00367965 and NCT00366093, and 36 more
Completion dates
oldest 2002-08; newest 2024-04-15
Show the evidence

Trial

  • NCT01710631
    2002-08
  • NCT00685269
    2004-01
  • NCT00352144
    2004-10
  • NCT00368030
    2004-10
  • NCT00367965
    2004-11
  • NCT00366093
    2005-01
14 further recorded trials
  • NCT00368160
    2005-07
  • NCT00235508
    2006-04
  • NCT00368056
    2006-06
  • NCT00319215
    2006-07
  • NCT00237497
    2006-10
  • NCT00374192
    2007-07
  • NCT00507117
    2007-10
  • NCT00295386
    2007-12
  • NCT00594087
    2008-06
  • NCT00798395
    2008-09
  • NCT02322645
    2008-10
  • NCT02322658
    2008-10
  • NCT00612157
    2009-02
  • NCT00813735
    2009-04

At the median, Eszopiclone's trials enrolled 57 people — anything larger?


Median enrolment
57
Largest enrolment
4876
Registered trials counted
92

What do 1458 spontaneous reports say about Eszopiclone — 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.

Eszopiclone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1458 reaction mentions were counted: dysgeusia 596; insomnia 375; somnolence 100; suicide attempt 92. open-targets-adr · CHEMBL1522 · 2026-06-24

Show the evidence
  • dysgeusia
    596
  • insomnia
    375
  • somnolence
    100
  • suicide attempt
    92
  • middle insomnia
    70
  • amnesia
    56
4 more recorded rows
  • nightmare
    53
  • initial insomnia
    44
  • hallucination
    38
  • paradoxical drug reaction
    34

recorded 2026-06-24 · last checked 2026-09-04

Eszopiclone and CYP3A4 and CYP2E1: shared by which compounds?


CYP3A4 and CYP2E1 appear in Eszopiclone's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30

Interpretation pharmacokinetics

Show the evidence

CYP2E1

  • pharmacokinetics
    In vitro studies have shown that CYP3A4 and CYP2E1 enzymes are involved in the metabolism of eszopiclone.
  • pharmacokinetics
    Drug Interactions Eszopiclone is metabolized by CYP3A4 and CYP2E1 via demethylation and oxidation.

CYP3A4

  • pharmacokinetics
    In vitro studies have shown that CYP3A4 and CYP2E1 enzymes are involved in the metabolism of eszopiclone.
  • pharmacokinetics
    Drug Interactions Eszopiclone is metabolized by CYP3A4 and CYP2E1 via demethylation and oxidation.
  • pharmacokinetics
    Coadministration of eszopiclone 3 mg to subjects receiving ketoconazole, a potent inhibitor of CYP3A4, 400 mg daily for 5 days, resulted in a 2.2-fold increase in exposure to eszopiclone.

recorded 2026-08-30 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL1522
PubChem CID
969472
CAS number
138729-47-2
RxCUI
461016
InChIKey
GBBSUAFBMRNDJC-INIZCTEOSA-N
Also called
Eszopiclon, Estorra, Eszopiclona, Eszopiclone civ, Zopiclone s-form, sep-190, 1-PIPERAZINECARBOXYLIC ACID, 4-METHYL-, (5S)-6-(5-CHLORO-2-PYRIDINYL)-6,7-DIHYDRO-7-OXO-5H-PYRROLO(3,4-B)PYRAZIN-5-YL ESTER, ESZOPICLONE CIV [USP-RS], ESZOPICLONE [HSDB], ESZOPICLONE [JAN], ESZOPICLONE [MART.], ESZOPICLONE [ORANGE BOOK]
Development code
GSK-1755165, (S)-ZOPICLONE
Trade name
Lunesta
Sources (9)

Sources

3 more sources
  • openfda-label c4ff1d6a-918e-c046-e053-2a95a90a9c9b ·
  • openfda-label+europepmc K1:UZX80K71OE ·
  • national registers US, CA ·

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

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 9 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.