Applies to calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate: oral solution.
Warning
Oral route (Solution)
Central Nervous System DepressionCalcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate is a CNS depressant. Clinically significant respiratory depression and obtundation may occur in patients treated with calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate at recommended doses. Many patients who received calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate during clinical trials in narcolepsy and idiopathic hypersomnia were receiving central nervous system stimulantsAbuse and MisuseThe active moiety of calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate is oxybate or 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, calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Xywav and Xyrem REMS.
Serious side effects
Along with its needed effects, calcium oxybate / magnesium oxybate / potassium oxybate / 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 calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate:
More common
- Bedwetting
- sleepiness or unusual drowsiness
- sleepwalking
Less common
- Anxiety
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- confusion about identity, place, and time
- discouragement
- feeling sad or empty
- irritability
- lack of appetite
- loss of interest or pleasure
- pain in the arm or leg
- seeing, feeling, or hearing things that are not there
- sleep paralysis
- thoughts of killing oneself
- tremor
- trouble breathing
- trouble concentrating
- trouble sleeping
- unusual tiredness or weakness
Incidence not known
- Being forgetful
- blurred vision
- chest tightness
- decrease in the amount of urine
- dizziness
- falls
- fever
- headache
- hives, itching, skin rash
- hoarseness
- increased urge to urinate during the 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
- trouble swallowing
- waking to urinate at night
- weight gain
Get emergency help immediately if any of the following symptoms of overdose occur while taking calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate:
Symptoms of overdose
- Agitation
- chest pain or discomfort
- clumsiness
- drowsiness
- lightheadedness, dizziness, or fainting
- loss of consciousness
- loss of strength or energy
- low body temperature
- muscle pain or weakness
- seizures
- shakiness and unsteady walk
- shivering
- slow or irregular heartbeat
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual weak feeling
- weak or feeble pulse
Other side effects
Some side effects of calcium oxybate / magnesium oxybate / potassium oxybate / 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
- Decreased weight
- diarrhea
- dry mouth
- increased sweating
- nausea
- vomiting
Less common
- Clenching, gnashing, or grinding teeth
- feeling drunk
- snoring
Incidence not known
- Difficulty in moving
For Healthcare Professionals
Applies to calcium oxybate / magnesium oxybate / potassium oxybate / sodium oxybate: oral liquid.
General
The most commonly reported side effects included headache, nausea, dizziness, and decreased appetite.[Ref]
Nervous system
Very common (10% or more): Headache (up to 20%)
Common (1% to 10%): Dizziness, paresthesia, somnolence, tremor
Frequency not reported: Attention disturbance, cataplexy, central nervous system depression, sleep paralysis
Postmarketing reports: Memory impairment[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 17%), vomiting (up to 16%)
Common (1% to 10%): Diarrhea, dry mouth[Ref]
Psychiatric
Very common (10% or more): Enuresis (up to 18%)
Common (1% to 10%): Anxiety, depressed mood, depression, irritability, parasomnia
Frequency not reported: Abnormal dreams, abnormal sleep-related event, abuse, affect lability, agitation, disorientation, other behavioral adverse reactions, other psychiatric adverse reactions, panic attack, rapid eye movements sleep abnormal, sleep-disordered breathing, sleep-related eating disorder, sleep talking, sleep terror, somnambulism, suicidal ideation, suicidality, tactile hallucination, tension[Ref]
Metabolic
Very common (10% or more): Decreased appetite (up to 12%)
Common (1% to 10%): Decreased appetite
Postmarketing reports: Fluid retention[Ref]
Other
Common (1% to 10%): Fatigue
Frequency not reported: Asthenia, feeling drunk, misuse, pain
Postmarketing reports: Fall, hangover[Ref]
Musculoskeletal
Common (1% to 10%): Muscle spasms
Frequency not reported: Extremity pain
Postmarketing reports: Arthralgia[Ref]
Dermatologic
Common (1% to 10%): Hyperhidrosis
Frequency not reported: Night sweats[Ref]
Respiratory
Frequency not reported: Respiratory depression, sleep apnea syndrome[Ref]
Cardiovascular
Postmarketing reports: Hypertension[Ref]
Hypersensitivity
Postmarketing reports: Hypersensitivity[Ref]
Ocular
Postmarketing reports: Blurred vision[Ref]
Genitourinary
Postmarketing reports: Nocturia[Ref]
