Idiopathic hypersomnia
disease diseaseOn this page
Also known as idiopathic hypersomnolenceprimary hypersomnia
Summary
Idiopathic hypersomnia (MONDO:0018044) is a disease and 40 clinical trials. Top therapeutic interventions include pitolisant, oxybate, and solriamfetol. A subtype of hypersomnia — broader associated-gene and molecular evidence is on the parent page (see Disease family below).
At a glance
- Prevalence: 1-5 / 10 000 (Europe) [Orphanet-validated]
- Phenotypes (HPO): 12
- Clinical trials: 40
Clinical features
Epidemiology
Prevalence records
1 prevalence record(s), Orphanet:
| Type | Class | Value | Geography | Validation |
|---|---|---|---|---|
| Point prevalence | 1-5 / 10 000 | 30 | Europe | Validated |
Signs & symptoms
Clinical features (HPO)
12 HPO clinical features (Orphanet curated; top 12 by frequency):
| HPO ID | Term | Frequency |
|---|---|---|
| HP:0001262 | Excessive daytime somnolence | Very frequent (80-99%) |
| HP:0002360 | Sleep abnormality | Very frequent (80-99%) |
| HP:0100786 | Hypersomnia | Very frequent (80-99%) |
| HP:0000736 | Short attention span | Frequent (30-79%) |
| HP:0002354 | Memory impairment | Frequent (30-79%) |
| HP:0033630 | Brain fog | Frequent (30-79%) |
| HP:6000456 | Sleep drunkeness | Frequent (30-79%) |
| HP:0000716 | Depression | Occasional (5-29%) |
| HP:0002519 | Hypnagogic hallucinations | Occasional (5-29%) |
| HP:0006896 | Hypnopompic hallucinations | Occasional (5-29%) |
| HP:0025233 | Sleep paralysis | Occasional (5-29%) |
| HP:0025267 | Snoring | Very rare (<1-4%) |
Identifiers
Disease identifiers
| Field | Value |
|---|---|
| Canonical name | idiopathic hypersomnia |
| Mondo ID | MONDO:0018044 |
| MeSH | D020177 |
| Orphanet | 33208 |
| ICD-10-CM | F51.11 |
| ICD-11 | 631826564 |
| NCIT | C116343 |
| SNOMED CT | 3731000119107 |
| UMLS | C0751757 |
| MedGen | 155626 |
| GARD | 0008737 |
| Is cancer (heuristic) | no |
Also known as: idiopathic hypersomnolence · primary hypersomnia
Disease family
This is a subtype of hypersomnia. Genetic, therapeutic, and trial evidence is largely curated at the broader-term level — see the parent page for the associated-gene cohort and molecular evidence.
Classification path: disease › human disease › disease by developmental or physiological process › sleep disorder › sleep-wake disorder › hypersomnia › idiopathic hypersomnia
Subtypes (2): idiopathic hypersomnia with long sleep time, idiopathic hypersomnia without long sleep time
Genetics & variants
GWAS landscape
No GWAS associations recorded — common-variant (GWAS) studies don’t cover this disease (typical for Mendelian / rare diseases). See the curated gene cohort and Mendelian overlap below.
Variant details and genetic-evidence tiers
No tiered GWAS variants or ClinVar records for this disease.
Genes & proteins
No associated-gene cohort resolved for this disease. Atlas builds the molecular and therapeutic sections — associated genes, protein families, druggability, pathways, interactions, and drug associations — by aggregating over a disease’s associated genes (resolved via GWAS / GenCC / ClinVar / CIViC), and none resolved here. This is expected for antibody-mediated, autoimmune, or otherwise non-gene-defined conditions; the curated evidence for this disease is its clinical features, GWAS susceptibility, and clinical trials (above).
Function
No pathway enrichment — requires an associated-gene cohort.
Therapeutics
Drugs indicated or in trials for this disease
No drug has an approved disease-direct ChEMBL indication for this disease.
3 drugs in clinical trials for this disease (phase 2–3, investigational): efficacy not established — a trial record, not an indication.
| Drug | Highest phase |
|---|---|
| Pitolisant | Phase 3 |
| Clarithromycin | Phase 2 |
| Serdexmethylphenidate | Phase 2 |
Clinical trials & evidence
Clinical trials
Clinical trials: 40.
Phase distribution (across all retrieved trials)
| Phase | Trials |
|---|---|
| Not specified | 15 |
| PHASE2 | 12 |
| PHASE3 | 5 |
| PHASE4 | 3 |
| PHASE2/PHASE3 | 2 |
| PHASE1 | 2 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05837091 | PHASE4 | RECRUITING | Low Sodium Oxybate in Patients With Idiopathic Hypersomnia |
| NCT07077278 | PHASE4 | NOT_YET_RECRUITING | Effect of Low Sodium Oxybate (LXB) on Autonomic Symptom Burden in Idiopathic Hypersomnia Patients With Postural Tachycardia Syndrome |
| NCT05875974 | PHASE4 | COMPLETED | A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy |
| NCT06767683 | PHASE2/PHASE3 | RECRUITING | A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia |
| NCT07500090 | PHASE3 | RECRUITING | A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) |
| NCT03533114 | PHASE3 | COMPLETED | A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension |
| NCT03597555 | PHASE2/PHASE3 | COMPLETED | Sodium Oxybate in Idiopathic Hypersomnia |
| NCT05156047 | PHASE3 | COMPLETED | A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia |
| NCT05458128 | PHASE3 | COMPLETED | A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia |
| NCT06525077 | PHASE3 | COMPLETED | Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) |
| NCT06252571 | PHASE2 | RECRUITING | a Chronobiological Treatment Combining Evening Melatonin and Morning Light Therapy in Idiopathic Hypersomnia: a Prospective, Double Bind, Randomized, Placebo-controlled -Trial |
| NCT06590662 | PHASE2 | NOT_YET_RECRUITING | Efficacy and Tolerance of Solriamfetol in Patients Affected with Idiopathic Hypersomnia. |
| NCT06752668 | PHASE2 | RECRUITING | A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia |
| NCT06812078 | PHASE2 | RECRUITING | A Study of TAK-360 in Adults With Idiopathic Hypersomnia |
| NCT06843590 | PHASE2 | RECRUITING | A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia |
| NCT07096674 | PHASE2 | RECRUITING | A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia |
| NCT01146600 | PHASE2 | COMPLETED | Clarithromycin for the Treatment of Hypersomnia |
| NCT01183312 | PHASE1/PHASE2 | COMPLETED | Flumazenil for the Treatment of Primary Hypersomnia |
| NCT02512588 | PHASE2 | COMPLETED | A Study of Safety and Efficacy of BTD-001 in Treatment of Patients With Idiopathic Hypersomnia (IH) or Narcolepsy Type 2 |
| NCT03542851 | PHASE2 | UNKNOWN | A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia |
| NCT03772314 | PHASE2 | COMPLETED | Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia |
| NCT04026958 | PHASE2 | COMPLETED | Clarithromycin Mechanisms in Hypersomnia Syndromes |
| NCT05668754 | PHASE2 | COMPLETED | Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH |
| NCT06644573 | PHASE1 | NOT_YET_RECRUITING | Evaluating the Efficacy and Safety of PROSOMNIA Sleep Therapy™ in Patients With Sleep Deprivation and Chronic Insomnia |
| NCT04091438 | PHASE1 | COMPLETED | A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia |
| NCT01793168 | Not specified | RECRUITING | Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford |
| NCT04330963 | Not specified | RECRUITING | International Swiss Primary Hypersomnolence and Narcolepsy Cohort Study |
| NCT05321355 | Not specified | RECRUITING | Mainz Register of Patients With Sleep Disorders |
| NCT05371483 | Not specified | ENROLLING_BY_INVITATION | Cardiovascular and Cognitive Implications of Central Disorders of Hypersomnolence and Their Treatments |
| NCT05615584 | Not specified | RECRUITING | Spectrometry (MRM) Versus I 125 Radioimmunoassay (RIA) for Quantification of Orexin-A of Patients With Hypersomnolence |
| NCT06457945 | Not specified | RECRUITING | Mind-wandering and Predictive Processes in Narcolepsy: a Putative Mechanism Through Covert REM Intrusions |
| NCT06484348 | Not specified | RECRUITING | Deciphering the Interactions Between Food Intake, Sleepiness, and Nighttime Sleep Quality in Patients With Type 1 Narcolepsy and Idiopathic Hypersomnia |
| NCT07006233 | Not specified | RECRUITING | A Novel Approach to Manage Symptoms of Narcolepsy and Idiopathic Hypersomnia |
| NCT01719315 | Not specified | COMPLETED | Neurophysiologic Correlates of Hypersomnia |
| NCT03356938 | Not specified | COMPLETED | The Role of the Circadian System in Neurological Sleep-wake Disorders |
| NCT03904238 | Not specified | COMPLETED | Psychosocial Adjunctive Treatment for Hypersomnia (PATH) |
| NCT04827329 | Not specified | COMPLETED | Anesthetic Management of Patients With Chronic Sleep Disorders |
| NCT05778721 | Not specified | UNKNOWN | Psychiatric Co-morbidities and Socio-demographic Characteristics in Patients With Idiopathic Hypersomnia |
| NCT06153615 | Not specified | UNKNOWN | Local Sleep in Idiopathic Hypersomnia |
| NCT06251063 | Not specified | COMPLETED | Improving Social Relationships for Adolescents With Central Disorders of Hypersomnolence |
Drugs tested across these trials (top 30)
| Molecule | Max phase | Trials referencing |
|---|---|---|
| PITOLISANT | 4 | 6 |
| OXYBATE | 4 | 3 |
| SOLRIAMFETOL | 4 | 3 |
| FLUMAZENIL | 4 | 1 |
| MODAFINIL | 4 | 1 |
| SERDEXMETHYLPHENIDATE | 4 | 1 |
| DANAVOREXTON | 2 | 1 |
| PENTYLENETETRAZOL | 2 | 1 |