This page shows what was measured, who it was measured in, and what that does not settle.
What Oxybate does in the body
Cataplexy or excessive daytime sleepiness
From the FDA-approved label: XYWAV is a CNS depressant. The exact mechanism of action of XYWAV in the treatment of narcolepsy and idiopathic hypersomnia is unknown. XYWAV is a mixture of calcium oxybate, magnesium oxybate, potassium oxybate, and sodium oxybate (gamma-hydroxybutyrate). Gamma-hydroxybutyrate (GHB) is an endogenous compound and metabolite of the neurotransmitter GABA. It is hypothesized that the therapeutic effects of XYWAV are mediated through GABA B actions during sleep at noradrenergic and dopaminergic neurons, as well as at thalamocortical neurons.
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 · 30IW36W5B2 · read 2026-08-29
Its recorded molecular formula is C4H7NaO3, weighing 126.09 g/mol.
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · 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 99 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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 18 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 reviewer3 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.
Energy
∅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 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.
Fertility and sexual health
∅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.
∅Nothing in the sources checkedNo registered study lists a symptom measure for this goal.
∅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
assessment of insomnia severity index; assessment of pittsburgh sleep quality index; pittsburgh sleep quality index; total sleep time
Energy
assessment of fatigue
Fertility and sexual health
sexual arousal
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
3 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.
Change From Baseline to End of Treatment (EOT) Visit on the 24-hour Average Systolic Blood Pressure (SBP) in mmHg
✗ The study did not show it
Who was studied
NCT05869773
How many people
155
Study design
Phase 4
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
Participant preference for selecting the extended vs non-extended release oxybates
✗ The study did not show it
Who was studied
NCT06809803
How many people
36
Study design
Phase 2
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 in Total Sleep Time
✗ The study did not show it
Who was studied
NCT05837091
How many people
30
Study design
Phase 4
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 3 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.6 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□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.
assessment of clinical global impression change
assessment of insomnia severity index
assessment of pittsburgh sleep quality index
assessment of fatigue
pittsburgh sleep quality index
symptom severity
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
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 (12)
pharmacokinetics
primary efficacy variable was the mean apnea hypopnea index
vital signs
assessment of sleepiness
reporting adverse events
epworth sleepiness scale
daytime sleepiness
safety
sexual arousal
major congenital malformation
total sleep time
epworth sleepiness scale scores
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. 0.5 to 1 hour hours
Read from the label, which states: “GHB has an elimination half-life of 0.5 to 1 hour.”
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.
XYWAV is a central nervous system depressant indicated for the treatment of: • Cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy ( 1.1 ). • Idiopathic Hypersomnia (IH) in adults ( 1.2 ). 1.1 Narcolepsy XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
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 sodium oxybate oral solution in pediatric patients below the age of 7 years have not been established.”
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-30
On older people, the label states: “Clinical studies of sodium oxybate oral solution in patients with narcolepsy did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.”
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women.”
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary GHB is excreted in human milk after oral administration of sodium oxybate.”
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-30
On people with reduced liver function, the label states: “Because of an increase in exposure to sodium oxybate oral solution, the starting dose should be reduced by half in patients with hepatic impairment [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].”
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · 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
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: S1, S2, S5, S6.
No source is stored against this line.
What is in the pack
Sold as solution, 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.
Oxybate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7183 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
nausea — 1012 reaction mentions
anxiety — 811 reaction mentions
depression — 787 reaction mentions
somnolence — 769 reaction mentions
condition aggravated — 671 reaction mentions
feeling abnormal — 668 reaction mentions
insomnia — 660 reaction mentions
dizziness — 632 reaction mentions
weight decreased — 602 reaction mentions
sleep apnoea syndrome — 571 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
30 products list this as an active ingredient in the United States drug directory. 29 of them contain it and nothing else.
FDA National Drug Code directory · 62207-993 · read 2026-08-29
They are sold as for suspension, extended release, powder and solution, taken oral.
FDA National Drug Code directory · 62207-993 · read 2026-08-29
The regulator's established pharmacologic class for it is central nervous system depressant [epc], central nervous system depression [pe] and decreased central nervous system organized electrical activity [pe].
FDA National Drug Code directory · 62207-993 · read 2026-08-29
7 published labels name it as an active ingredient. 6 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-29
12292 marketed supplement labels list this ingredient, classed as botanical with nutrients, mineral, other combinations and single vitamin and mineral.
Those labels carry all other, approved health and nutrient claims. A claim of that kind is written by the manufacturer and is not assessed by any regulator, so its presence says nothing about whether it is true.
sodium oxybate is oral at 3 DOSAGE FORMS AND STRENGTHS Sodium oxybate oral solution is a clear to slightly opalescent oral solution, in a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate)., recorded as fda label in effect 2026-04-21 in the United States.
US prescribing information · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · read 2026-08-30
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.
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 Oxybate 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 Oxybate 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 people◇Read 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
6 documents were read for this substance.
RNAWiki source record
6 of them state the same halfLife, and they agree.
RNAWiki source record
5 of them state the same bioavailability, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
30IW36W5B2
CAS registry number
591-81-1
PubChem compound
10413
ChEBI
30830
RxNorm concept
2387302
EMA substance identifier
100000125890
DrugBank
DB01440
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: S1, S2, S5, S6.
✓ Passed
Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
7 approved applications cover products containing this substance. The earliest was NDA021196, approved 20020717 to JAZZ PHARMS.
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.
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Recorded evidence blocks (11)
Q2
What did Oxybate's largest trial (1329 people) and its longest (10 years) measure?
1329 people in Oxybate's largest registered study, 10 years in its longest registered window, measuring concentration in plasma of GHB. ClinicalTrials.gov · 2026-09-01
15 phase2, 14 phase3, 14 phase4, 6 phase1, 4 na, 2 na or unstated; NCT04648423; 2012-01; no ageing endpoint recorded. Last human test completed 2026, NCT06525077.
Interpretation These counts include studies where Oxybate 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.
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phase2
15
phase3
14
phase4
14
phase1
6
na
4
na or unstated
2
1 more recorded row
Last recorded human testNCT06525077
2026-03-25
recorded 2026-09-01 · last checked 2026-09-04
Q3
Oxybate was tested only in human — what did it show?
1 recorded entry; human; also "Sodium Oxybate Oral Solution (6 grams)"
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humanNCT00803023
Sodium Oxybate Oral Solution (6 grams)
recorded 2026-09-01 · last checked 2026-09-04
Q6
Oxybate's half-life is 0.5 to 1 hour hours — which schedules were studied?
0.5 to 1 hour hours, the half-life Oxybate's label states. openfda-label · 5dcf9a5c-312b-420b-82f3-42177d8f9ee4 · 2026-08-30
bioavailability 88% %.
Show the evidence
half life
0.5 to 1 hour hours; GHB has an elimination half-life of 0.5 to 1 hour.
tmax
Effect of Food Administration of sodium oxybate oral solution immediately after a high-fat meal resulted in delayed absorption (average T max increased from 0.75 hr to 2 hr) and a reduction in C max of GHB by a mean of 59% and of systemic exposure (AUC) by 37%.
bioavailability
88% %; Absorption Following oral administration of sodium oxybate oral solution, GHB is absorbed rapidly across the clinical dose range, with an absolute bioavailability of about 88%.
recorded 2026-08-30 · last checked 2026-09-04
Q7
Which of assessment of clinical global impression change, assessment of fatigue and assessment of insomnia severity index did Oxybate's trials measure?
assessment of clinical global impression change, assessment of fatigue and assessment of insomnia severity index lead 18 outcome terms across Oxybate's trials. ClinicalTrials.gov · 2026-09-01
Interpretation assessment of clinical global impression change, assessment of insomnia severity index, assessment of pittsburgh sleep quality index, assessment of fatigue, assessment of sleepiness and reporting adverse events follow.
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pharmacokinetics
1
primary efficacy variable was the mean apnea hypopnea index
1
vital signs
1
assessment of clinical global impression change
1
assessment of insomnia severity index
1
assessment of pittsburgh sleep quality index
1
12 more recorded rows
assessment of fatigue
1
assessment of sleepiness
1
reporting adverse events
1
pittsburgh sleep quality index
1
epworth sleepiness scale
1
daytime sleepiness
1
safety
1
sexual arousal
1
symptom severity
1
major congenital malformation
1
total sleep time
1
epworth sleepiness scale scores
1
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which of Oxybate's 8 ongoing trials reports first?
Major congenital malformation; Change in Total Sleep Time; latest 2030-06-30
Show the evidence
Trial
NCT05536011
"WAKIX® (Pitolisant) Pregnancy Registry"; n 1329; "Major congenital malformation"; 2030-06-30
NCT05837091
"Low Sodium Oxybate in Patients With Idiopathic Hypersomnia"; n 30; "Change in Total Sleep Time"; 2027-06
NCT06421532
"Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy"; n 60; "Morning amyloid-beta 40 and 42 levels in cerebrospinal fluid"; 2027-09-27
NCT06809803
"Extended-release Sodium Oxybate in Children"; n 36; "Participant preference for selecting the extended vs non-extended release oxybates"; 2027-07
NCT06950281
"Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks"; n 52; "Change in average weekly frequency of nocturnal cluster headache attacks (verum vs placebo)"; 2029-05
NCT07041203
"Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor"; n 8; "Efficacy of Lumryz"; 2027-09-30
2 further recorded trials
NCT07625280
"A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH"; n 120; "Change in Epworth Sleepiness Scale (ESS) scores"; 2028-01-06
NCT07794982
"Sodium Oxybate for Postoperative Sleep Disturbance After Thoracic Surgery"; n 360; "Subjective sleep quality on Post-Operative Day 1 (POD1)"; 2027-12
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which 12 trials of Oxybate posted no result?
Posted no result
12 of 12 completed trials
Registrations
NCT00049803, NCT00058955, NCT00506974, NCT02090504, NCT00514995 and NCT04648423, and 6 more
Completion dates
oldest 2004-04; newest 2023-10-10
Show the evidence
Trial
NCT00049803
2004-04
NCT00058955
2005-03
NCT00506974
2008-06
NCT02090504
2009-05
NCT00514995
2011-04
NCT04648423
2012-01
6 further recorded trials
NCT02215499
2014-11
NCT02342366
2014-12
NCT02111122
2016-08
NCT04322214
2020-04-30
NCT04508166
2022-01-29
NCT05085873
2023-10-10
Q10
At the median, Oxybate's trials enrolled 50 people — anything larger?
Median enrolment
50
Largest enrolment
1329
Registered trials counted
52
Q11
What do 7183 spontaneous reports say about Oxybate — 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.
Oxybate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 7183 reaction mentions were counted: nausea 1012; anxiety 811; depression 787; somnolence 769. open-targets-adr · CHEMBL1200682 · 2026-06-24
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nausea
1012
anxiety
811
depression
787
somnolence
769
condition aggravated
671
feeling abnormal
668
4 more recorded rows
insomnia
660
dizziness
632
weight decreased
602
sleep apnoea syndrome
571
recorded 2026-06-24 · last checked 2026-09-04
Q12
Oxybate and CYP1A2, CYP2C19 and CYP2C9: shared by which compounds?
CYP1A2, CYP2C19 and CYP2C9 appear in Oxybate's recorded interaction sentences, 5 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP1A2pharmacokinetics
Drug Interactions Studies Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 mcg/mL), a level considerably higher than levels achieved with recommended doses.
CYP2C19pharmacokinetics
Drug Interactions Studies Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 mcg/mL), a level considerably higher than levels achieved with recommended doses.
CYP2C9pharmacokinetics
Drug Interactions Studies Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 mcg/mL), a level considerably higher than levels achieved with recommended doses.
CYP2D6pharmacokinetics
Drug Interactions Studies Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 mcg/mL), a level considerably higher than levels achieved with recommended doses.
CYP2E1pharmacokinetics
Drug Interactions Studies Studies in vitro with pooled human liver microsomes indicate that sodium oxybate does not significantly inhibit the activities of the human isoenzymes CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A up to the concentration of 3 mM (378 mcg/mL), a level considerably higher than levels achieved with recommended doses.
recorded 2026-08-30 · last checked 2026-09-04
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