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.
Summary
Common side effects of Xyrem include: dizziness and nausea. Continue reading for a comprehensive list of adverse effects.
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
- 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 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]
