Drug updated on 4/17/2024
| Dosage Form | Solution (oral; 0.5 g/ml) |
| Drug Class | Central nervous system depressants |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Summary
- Sodium oxybate (Xyrem) is indicated for the treatment of cataplexy or excessive daytime sleepiness in patients 7 years and older with narcolepsy.
- Four studies were reviewed, focusing on the safety and effectiveness of sodium oxybate compared to other pharmacological interventions for narcolepsy.
- In terms of effectiveness, solriamfetol was found to be superior to sodium oxybate in improving excessive daytime sleepiness. However, sodium oxybate showed wide-ranging efficacy in improving a variety of narcolepsy-related symptoms including cataplexy attacks and subjective daytime sleepiness.
- Regarding safety, while effective, sodium oxybate presents less favorable tolerability due to dose-dependent side effects. High doses and recurrent use may lead to potential risks such as possible neurotoxicity leading to cognitive impairments.
- Compared with solriamfetol, which shows superior efficacy but might not offer a better efficacy-safety balance than sodium oxybate; pitolisant and modafinil are suggested as options based on individual health profiles and potential side effects.
- The studies underscored the importance of tailored treatment approaches considering variations in responses between drugs. Detailed subgroup analyses were not provided, indicating that these findings apply broadly across the general narcolepsy patient population without delving into specific subgroups.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Xyrem (sodium oxybate) Prescribing Information. | 2023 | Jazz Pharmaceuticals, Inc., Palo Alto, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacological interventions for excessive daytime sleepiness in adults with narcolepsy: A systematic review and network meta-analysis. | 2022 | Journal of Clinical Medicine |
| Cognitive impairment following clinical or recreational use of gammahydroxybutyric acid (GHB): A systematic review. | 2022 | Current Neuropharmacology |
| Treatment of central disorders of hypersomnolence: An American academy of sleep medicine systematic review, meta-analysis, and GRADE assessment. | 2021 | Journal of Clinical Sleep Medicine |
| Gamma-hydroxybutyrate (GHB) for narcolepsy in adults: An updated systematic review and meta-analysis. | 2019 | Sleep Medicine |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Treatment of central disorders of hypersomnolence: An American academy of sleep medicine clinical practice guideline. | 2021 | Journal of Clinical Sleep Medicine |