Xyrem Side Effects

Generic name: sodium oxybate

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 24, 2023.

Note: This document provides detailed information about Xyrem Side Effects associated with sodium oxybate. Some dosage forms listed on this page may not apply specifically to the brand name Xyrem.

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

Important warnings This medicine can cause some serious health issues

Oral route (solution)

Warning: Central Nervous System (CNS) Depression and Abuse and Misuse. Central Nervous System Depression. Sodium 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 Misuse. Sodium 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 Abuse. Central Nervous System (CNS) Depression. Sodium 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 Misuse. Sodium 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

• bedwetting
• sleep walking

Less common

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in behavior
• choking or gasping sounds
• daytime sleepiness or tiredness
• headache
• lack of appetite
• loud or frequent snoring
• rapid weight gain
• seeing, hearing, or feeling things that are not there
• thoughts of killing oneself
• trouble sleeping
• unusual weight gain or loss
• waking to urinate at night

Incidence not known

• being forgetful
• blurred vision
• decrease in the amount of urine
• dizziness
• fever
• hives, itching, skin rash
• hoarseness
• increase urge to urinate at night
• irritation
• joint pain, stiffness, or swelling
• nervousness
• noisy, rattling breathing
• pounding in the ears
• redness of the skin
• swelling of the face, fingers, hands, feet, or lower legs
• tightness in the chest
• trouble breathing or swallowing
• weight gain

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

Symptoms of overdose

• agitation
• bluish lips or skin, not breathing
• chest pain or discomfort
• clumsiness
• confusional, agitated combative state
• drowsiness
• generalized slowing of mental and physical activity
• inability to hold bowel movement or urine
• increased sweating
• lightheadedness, dizziness, or fainting
• loss of consciousness
• muscle aches or weakness
• seizures
• shakiness and unsteady walk
• shivering
• slow or irregular heartbeat
• trembling or other problems with muscle control or coordination
• unusual tiredness or weakness
• weak or feeble pulse

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

• diarrhea
• difficulty passing urine (dribbling)
• increased frequency, urgency, or burning on urination
• increased sweating
• nausea
• vomiting

Less common

• dry mouth

Incidence not known

• difficulty with moving

For healthcare professionals

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

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

• Common (1% to 10%): Asthenia, fall, fatigue, feeling drunk, pain
• Frequency not reported: Misuse, tinnitus
• Postmarketing reports: Hangover^[Ref]

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

• What's the difference between Xywav and Xyrem?
• Will Xyrem show up on a drug test?
• Does Xyrem cause weight gain or loss?
• How does Xyrem work for narcolepsy?
• Is Xyrem a controlled substance / narcotic drug of abuse?
• Can any doctor prescribe Xyrem?
• How much sodium is in Xyrem?
• Can you take Xyrem while pregnant?

Further information

Xyrem side effects can vary depending on the individual. 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.

Medical Disclaimer