Xyrem

Jazz Pharmaceuticals · FDA-approved active Small molecule Quality 16/100

Xyrem is a Small molecule drug developed by Jazz Pharmaceuticals. It is currently FDA-approved for Cataplexy and narcolepsy, Narcolepsy. Also known as: Sodium Oxybate, Sodium Oxybate Placebo, gamma-hydroxybutyrate.

Xyrem, also known as sodium oxybate, is a small molecule medication used to treat symptoms of narcolepsy, including sudden muscle weakness and excessive daytime sleepiness. It is also approved to treat alcohol dependence and alcohol withdrawal syndrome in certain countries, including Italy and Austria.

At a glance

Generic name	Xyrem
Also known as	Sodium Oxybate, Sodium Oxybate Placebo, gamma-hydroxybutyrate
Sponsor	Jazz Pharmaceuticals
Target	Calcium/calmodulin-dependent protein kinase type II subunit alpha, GABA-B receptor, Gamma-hydroxybutyrate receptor
Modality	Small molecule
Therapeutic area	Other
Phase	FDA-approved

Approved indications

• Cataplexy and narcolepsy
• Narcolepsy

Common side effects

• Nausea
• Dizziness
• Vomiting
• Somnolence
• Enuresis
• Tremor
• Feeling drunk
• Disturbance in attention
• Disorientation
• Sleepwalking
• Irritability
• Sleep paralysis

Serious adverse events

• Treatment discontinuation due to adverse reactions
• Respiratory depression
• Abuse and dependence
• CNS depression

Key clinical trials

• Stimulating Amyloid Clearance in Cerebral Amyloid Angiopathy (PHASE2)
• Safety and Efficacy of FT218 in Idiopathic Hypersomnia (REVITALYZ) (PHASE3)
• Sodium Oxybate Versus Midazolam for Comfort Sedation (PHASE4)
• Sodium Oxybate in Spasmodic Dysphonia and Voice Tremor (PHASE2, PHASE3)
• Extended-release Sodium Oxybate (Lumryz) in Spasmodic Dysphonia and Voice Tremor (PHASE1)
• Efficacy, Safety and Tolerability of Low Sodium Oxybate for Nocturnal Cluster Headache Attacks (PHASE2)
• Extended-release Sodium Oxybate in Children (PHASE2)
• An Open Label Study of FT218 in Subjects With Narcolepsy (PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Xyrem CI brief — competitive landscape report
• Xyrem updates RSS · CI watch RSS
• Jazz Pharmaceuticals portfolio CI

Frequently asked questions about Xyrem

What is Xyrem?

Xyrem is a Small molecule drug developed by Jazz Pharmaceuticals, indicated for Cataplexy and narcolepsy, Narcolepsy.

What is Xyrem used for?

Xyrem is indicated for Cataplexy and narcolepsy, Narcolepsy.

Who makes Xyrem?

Xyrem is developed and marketed by Jazz Pharmaceuticals (see full Jazz Pharmaceuticals pipeline at /company/jazz-pharmaceuticals).

Is Xyrem also known as anything else?

Xyrem is also known as Sodium Oxybate, Sodium Oxybate Placebo, gamma-hydroxybutyrate.

What development phase is Xyrem in?

Xyrem is FDA-approved (marketed).

What are the side effects of Xyrem?

Common side effects of Xyrem include Nausea, Dizziness, Vomiting, Somnolence, Enuresis, Tremor. Serious adverse events: Treatment discontinuation due to adverse reactions, Respiratory depression, Abuse and dependence, CNS depression.

What does Xyrem target?

Xyrem targets Calcium/calmodulin-dependent protein kinase type II subunit alpha, GABA-B receptor, Gamma-hydroxybutyrate receptor.

Related

• Target: All drugs targeting Calcium/calmodulin-dependent protein kinase type II subunit alpha, GABA-B receptor, Gamma-hydroxybutyrate receptor
• Manufacturer: Jazz Pharmaceuticals — full pipeline
• Therapeutic area: All drugs in Other
• Indication: Drugs for Cataplexy and narcolepsy
• Indication: Drugs for Narcolepsy
• Also known as: Sodium Oxybate, Sodium Oxybate Placebo, gamma-hydroxybutyrate