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Xyrem Side Effects

Generic name: sodium oxybate

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 12, 2023.

Note: This document contains side effect information about sodium oxybate. Some dosage forms listed on this page may not apply to the brand name Xyrem.

Applies to sodium oxybate: oral powder for suspension extended release, oral solution.

Warning

Oral route (Solution)

Warning: Central Nervous System (CNS) Depression and Abuse and MisuseCentral Nervous System DepressionSodium oxybate is a CNS depressant. In clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in adult patients treated with sodium oxybate. Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants.Abuse and MisuseSodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.Because of the risks of CNS depression and abuse and misuse, sodium oxybate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Xywav and Xyrem REMS.

Oral route (Powder for Suspension, Extended Release)

Warning: Central Nervous System Depression and Misuse and AbuseCentral Nervous System (CNS) DepressionSodium oxybate is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with sodium oxybate. Many patients who received sodium oxybate during clinical trials in narcolepsy were receiving central nervous system stimulants.Abuse and MisuseSodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB). Abuse or misuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death.Because of the risks of CNS depression and abuse and misuse, sodium oxybate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Lumryz REMS.

Serious side effects of Xyrem

Along with its needed effects, sodium oxybate (the active ingredient contained in Xyrem) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sodium oxybate:

More common

Less common

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking sodium oxybate:

Symptoms of overdose

Other side effects of Xyrem

Some side effects of sodium oxybate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to sodium oxybate: oral liquid, oral powder for reconstitution extended release.

General

The most commonly reported side effects included dizziness, headache, nausea, and enuresis.[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 20%), headache (up to 20%)

Common (1% to 10%): Balance disorder, cataplexy, disturbance in attention, dysgeusia, hypoesthesia, paresthesia, sedation, sleep paralysis, somnolence, tremor, vertigo

Uncommon (0.1% to 1%): Amnesia, myoclonus, restless legs syndrome

Frequency not reported: Central nervous system depression, convulsion, dyskinesia, loss of consciousness

Postmarketing reports: Memory impairment[Ref]

Disturbance in attention and paresthesia were dose-related, with the side effects occurring more frequently at 9 g/day.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 20%), vomiting (up to 11%)

Common (1% to 10%): Abdominal pain upper, diarrhea, dry mouth, upper abdominal pain

Uncommon (0.1% to 1%): Fecal incontinence[Ref]

Nausea and vomiting were dose-related, with the side effects occurring more frequently at 9 g/day.

The frequency of nausea was higher in women than in men.[Ref]

Psychiatric

Very common (10% or more): Enuresis (up to 19%)

Common (1% to 10%): Abnormal dreams, acute psychosis, anxiety, confusional state, depression, disorientation, enuresis nocturna, insomnia, irritability, middle insomnia, nervousness, nightmares, sleep disorder, sleepwalking, suicidal ideation

Uncommon (0.1% to 1%): Abnormal thinking, agitation, hallucination, initial insomnia, paranoia, psychosis, suicide attempt

Frequency not reported: Abuse, affect lability, aggression, bipolar disorder, bruxism, delusion, euphoric mood, homicidal ideation, increased libido, mania, other behavioral adverse reactions, other psychiatric adverse reactions, parasomnias, psychotic disorders, panic attack, sleep-disordered breathing, sleep-related eating disorder, suicidality, tactile hallucination

Postmarketing reports: Abnormal behavior, mood alteration[Ref]

Disorientation, enuresis, irritability, and sleepwalking were dose-related, with the side effects occurring more frequently at 9 g/day.[Ref]

Metabolic

Very common (10% or more): Weight decreased (up to 13%)

Common (1% to 10%): Anorexia, decreased appetite

Postmarketing reports: Dehydration, fluid retention, increased appetite[Ref]

Respiratory

Common (1% to 10%): Dyspnea, nasal congestion, nasopharyngitis, sinusitis, snoring

Frequency not reported: Choking sensation, respiratory depression, sleep apnea/sleep apnea syndrome[Ref]

Other

Feeling drunk was dose-related, with the side effect occurring more frequently at 9 g/day.[Ref]

Common (1% to 10%): Asthenia, fall, fatigue, feeling drunk, pain

Frequency not reported: Misuse, tinnitus

Postmarketing reports: Hangover[Ref]

Cardiovascular

Common (1% to 10%): Blood pressure increased, hypertension, palpitations, peripheral edema[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, muscle spasms, pain in extremity[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis, rash

Frequency not reported: Seborrhea, urticaria[Ref]

Genitourinary

Common (1% to 10%): Urinary incontinence

Frequency not reported: Micturition urgency, nocturia, pollakiuria[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Angioedema[Ref]

Frequently asked questions

References

1. Product Information. Xyrem (sodium oxybate). Orphan Medical. 2002.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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