Xyrem Side Effects

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, or cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

This medicine may cause unusual behavior while you are sleeping. Other people living in your house should monitor you for the possibility of urinary or fecal incontinence (loss of bladder or bowel control), or sleepwalking. Tell your doctor if these symptoms occur.

Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Xyrem

Along with its needed effects, sodium oxybate 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:

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:

For healthcare professionals

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

General adverse events

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]

See also:

Frequently asked questions

• Xywav vs Xyrem: What's the difference between them?
• Will Xyrem show up on a drug test?
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• How does Xyrem work for narcolepsy?
• Is Xyrem a controlled substance / narcotic drug of abuse?
• Does Xyrem cause weight gain or loss?
• What is Xyrem REMS?
• 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer