Sodium oxybate
Lumryz, Xyrem, Xywav (sodium oxybate) is a small molecule pharmaceutical. Sodium oxybate was first approved as Xyrem on 2002-07-17. It is used to treat cataplexy in the USA. It has been approved in Europe to treat cataplexy and narcolepsy.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lumryz | New Drug Application | 2023-06-07 |
| n/a | NDA authorized generic | 2022-10-04 |
| sodium oxybate | NDA authorized generic | 2023-04-25 |
| xyrem | New Drug Application | 2023-04-25 |
| xywav | New Drug Application | 2023-04-25 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SODIUM OXYBATE, LUMRYZ, AVADEL CNS | |||
| 2030-05-01 | ODE-431 | ||
| 2026-05-01 | NP | ||
CALCIUM OXYBATE / MAGNESIUM OXYBATE / POTASSIUM OXYBATE / SODIUM OXYBATE, XYWAV, JAZZ | |||
| 2028-08-12 | ODE-369 | ||
| 2027-07-21 | ODE-361 | ||
| 2024-08-12 | I-870 | ||
| 2023-07-21 | NP | ||
SODIUM OXYBATE, XYREM, JAZZ PHARMS | |||
| 2026-04-26 | PED | ||
| 2025-10-26 | ODE-231 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Oxybate, Lumryz, Avadel Cns | |||
| 11583510 | 2042-02-07 | U-3578 | |
| 10925844 | 2040-02-28 | DP | |
| 10272062 | 2037-07-21 | DP | |
| 10736866 | 2037-07-21 | DP | |
| 10952986 | 2037-07-21 | U-3601 | |
| 10973795 | 2037-07-21 | DP | |
| 11000498 | 2037-07-21 | DP | U-3580 |
| 11052061 | 2037-07-21 | DP | |
| 11065224 | 2037-07-21 | DP | |
| 11400065 | 2037-07-21 | U-3579 | |
| 11504347 | 2037-07-21 | DP | |
| 11602512 | 2037-07-21 | U-3577 | |
| 11602513 | 2037-07-21 | U-3576 | |
| Calcium Oxybate / Magnesium Oxybate / Potassium Oxybate / Sodium Oxybate, Xywav, Jazz | |||
| 11426373 | 2037-09-19 | U-3432 | |
| 8772306 | 2033-03-15 | U-1532, U-3198 | |
| 9050302 | 2033-03-15 | U-1532 | |
| 9486426 | 2033-03-15 | U-1532 | |
| 10213400 | 2033-03-15 | U-2499 | |
| 10864181 | 2033-03-15 | U-1532, U-3017 | |
| 11253494 | 2033-03-15 | U-3323, U-3324 | |
| 8591922 | 2033-01-11 | DP | |
| 8901173 | 2033-01-11 | DP | |
| 9132107 | 2033-01-11 | DP | |
| 10195168 | 2033-01-11 | DP | |
| 10675258 | 2033-01-11 | U-2938 | |
| 11554102 | 2033-01-11 | DP | |
| Sodium Oxybate, Xyrem, Jazz Pharms | |||
| 7668730 | 2024-06-16 | U-1110 | |
ATC Codes
HCPCS
No data
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Narcolepsy | D009290 | HP_0030050 | G47.4 | 3 | — | 8 | 4 | 3 | 18 |
| Disorders of excessive somnolence | D006970 | — | G47.1 | 2 | 2 | 5 | 2 | — | 10 |
| Cataplexy | D002385 | HP_0002524 | — | 1 | — | 4 | 1 | — | 6 |
| Sleepiness | D000077260 | — | R40.0 | 1 | 1 | 3 | 1 | — | 6 |
| Idiopathic hypersomnia | D020177 | — | G47.11 | — | 1 | 2 | 2 | — | 4 |
| Syndrome | D013577 | — | — | — | — | — | 4 | — | 4 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | — | 1 | — | 3 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 3 | — | 3 |
| Chronic fatigue syndrome | D015673 | EFO_0004540 | G93.31 | — | — | — | 3 | — | 3 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | 2 | — | 2 |
Show 9 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 4 | — | — | 5 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 4 | — | — | 5 |
| Tremor | D014202 | HP_0001337 | R25.1 | — | 3 | 1 | — | — | 3 |
| Dysphonia | D055154 | — | R49.0 | — | 2 | 1 | — | — | 2 |
| Hoarseness | D006685 | HP_0001609 | R49.0 | — | 2 | 1 | — | — | 2 |
| Sleep wake disorders | D012893 | — | G47 | — | — | 1 | — | — | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | 1 | — | — | 1 |
| Cluster headache | D003027 | HP_0012199 | G44.00 | — | — | 1 | — | — | 1 |
| Bulimia | D002032 | — | F50.2 | — | 1 | 1 | — | — | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | 1 | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 3 | — | — | — | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | 1 | 2 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 1 | — | — | 1 | 2 |
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | 1 | 2 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | — | — | 1 | 2 |
| Hemiplegia | D006429 | HP_0011099 | G81.0 | 1 | 1 | — | — | — | 1 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | 1 | — | — | — | 1 |
| Ventilator weaning | D015300 | — | — | — | 1 | — | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | 1 | — | — | — | 1 |
| Dyssomnias | D020920 | — | — | — | 1 | — | — | — | 1 |
Show 4 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv | D006678 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Traumatic brain injuries | D000070642 | — | S06 | 1 | — | — | — | — | 1 |
| Brain injuries | D001930 | — | S06.9 | 1 | — | — | — | — | 1 |
| Intrinsic sleep disorders | D020919 | — | F51.03 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Psychological trauma | D000067073 | — | — | — | — | — | — | 1 | 1 |
| Traumatic stress disorders | D040921 | — | — | — | — | — | — | 1 | 1 |
| Physiological stress | D013312 | — | — | — | — | — | — | 1 | 1 |
| Sleep deprivation | D012892 | — | F51.12 | — | — | — | — | 1 | 1 |
| Postoperative complications | D011183 | — | — | — | — | — | — | 1 | 1 |
| Kidney transplantation | D016030 | — | — | — | — | — | — | 1 | 1 |
| Hernia | D006547 | HP_0100790 | K40-K46 | — | — | — | — | 1 | 1 |
| Incisional hernia | D000069290 | HP_0004872 | K43.2 | — | — | — | — | 1 | 1 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sodium oxybate |
| INN | — |
| Description | Sodium oxybate, sold under the brand name Xyrem or Alcover among others, is a medication used to treat three symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness and alcohol dependence. It is used sometimes in France and Italy as an anesthetic given intravenously;: 15, 27–28  it is also approved and used in Italy and in Austria to treat alcohol dependence and alcohol withdrawal syndrome.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C([O-])CCCO.[Na+] |
Identifiers
| PDB | — |
| CAS-ID | 502-85-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200682 |
| ChEBI ID | — |
| PubChem CID | 23663870 |
| DrugBank | DB09072 |
| UNII ID | — |
Target
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Variants
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Financial
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Xywav – Jazz Pharmaceuticals
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Xyrem – Jazz Pharmaceuticals
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Estimated US medical usage
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Trends
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Additional graphs summarizing 1,325 documents
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Safety
Black-box Warning
Black-box warning for: Lumryz, N/a, Sodium oxybate, Xyrem, Xywav
Adverse Events
Top Adverse Reactions
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67,932 adverse events reported
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