Overview
Sodium oxybate (Xyrem) is a central nervous system (CNS) depressant used to treat cataplexy or excessive daytime sleepiness associated with narcolepsy. It is a sodium salt of gamma-Hydroxybutyric acid, an endogenous cerebral inhibitory neurotransmitter and a metabolite of the inhibitory neurotransmitter GABA. Due to its physiological effects, sodium oxybate is associated with a risk for substance misuse and abuse. Sodium oxybate has been misused to stimulate body growth and to induce euphoria, disinhibition, and sexual arousal as a "party drug" or "club drug." For safety reasons, sodium oxybate is a controlled substance only available through a restricted program in approved countries. An extended-release oral suspension formulation of sodium oxybate for narcolepsy, marketed under the brand name LUMRYZ, gained tentative FDA approval in July 2022 and was fully approved in May 2023. In some countries, sodium oxybate has been investigated and used in alcohol withdrawal syndrome (AWS) to aid abstinence maintenance in alcohol use disorders.
Indication
Sodium oxybate is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. In the US and in Europe, the drug is approved for use in patients 7 years of age and older while in Canada, it is not recommended in children under the age of 18, unless clearly needed.
Associated Conditions
- Cataplexy
- Excessive Daytime Sleepiness
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Not yet recruiting | Kristina Simonyan | ||
2025/01/27 | N/A | Active, not recruiting | |||
2024/07/29 | Phase 3 | Recruiting | |||
2020/12/01 | Phase 4 | Completed | Laboratorio Farmaceutico Ct S.r.l. | ||
2020/06/30 | Phase 3 | Completed | |||
2019/07/05 | Phase 4 | Completed | |||
2017/09/25 | Phase 2 | Completed | Kristina Simonyan | ||
2016/03/28 | Phase 3 | Completed | |||
2015/12/22 | Phase 4 | Completed | |||
2015/12/22 | Phase 3 | UNKNOWN | Ramin Khatami |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0054-9628 | ORAL | .5 g in 1 mL | 10/4/2022 | |
| Avadel CNS Pharmaceuticals, LLC | 13551-002 | ORAL | 6 g in 1 1 | 5/17/2023 | |
| Avadel CNS Pharmaceuticals, LLC | 13551-004 | ORAL | 9 g in 1 1 | 5/17/2023 | |
| Amneal Pharmaceuticals NY LLC | 69238-2391 | ORAL | .5 g in 1 mL | 4/25/2023 | |
| Jazz Pharmaceuticals, Inc. | 68727-100 | ORAL | 0.5 g in 1 mL | 4/28/2017 | |
| Avadel CNS Pharmaceuticals, LLC | 13551-003 | ORAL | 7.5 g in 1 1 | 5/17/2023 | |
| Avadel CNS Pharmaceuticals, LLC | 13551-001 | ORAL | 4.5 g in 1 1 | 5/17/2023 | |
| Jazz Pharmaceuticals, Inc. | 68727-150 | ORAL | 0.5 g in 1 mL | 3/10/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 10/13/2005 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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