Sodium oxybate oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral solution containing sodium oxybate.
Drugs List
Therapeutic Indications
Uses
Cataplexy associated with narcolepsy
Dosage
Each dose of sodium oxybate should be diluted with 60ml water prior to ingestion.
Food significantly reduces the bioavailability of sodium oxybate, and so patients should eat several hours (at least 2 to 3) before taking the first dose of sodium oxybate at bedtime. The same timing of dosing should always be observed in relation to meals.
Doses should be administered upon getting into bed and again between 2.5 to 4 hours later. It is recommended that both doses are made up at the same time.
Adults
The recommended starting dose is 4.5g/day administered in two divided equal doses of 2.25g, the second dose separated by at least 2.5 to 4 hours from the first.
The dose may be titrated up to a maximum of 9g/day in two divided doses based on efficacy and tolerability, by adjusting the dose up or down by increments of 1.5g/day. A minimum of one to two weeks is recommended between dosage increments.
Single doses of 4.5g should not be administered unless the patient has been previously titrated to that dose level.
Children
Children aged 7 years and weighing more than 15kg
Titration regimen
More than or equal to 45kg: less than or equal to 1.5g per day per week. Recommended maximum total daily dose: 0.2g/kg/day.
30kg to less than 45kg: less than or equal to 1g per day per week. Recommended maximum total daily dose: 0.2g/kg/day.
20kg to less than 30kg: less than or equal to 1g per day per week. Recommended maximum total daily dose: 0.2g/kg/day.
15kg to less than 20kg: less than or equal to 0.5g per day per week. Recommended maximum total daily dose: 9g/day.
Initial dose regime
More than or equal to 45kg: less than or equal to 4.5g per day, in two divided doses at bedtime and 2.5 to 4 hours later.
30kg to less than 45kg: less than or equal to 3g per day, in two divided doses at bedtime and 2.5 to 4 hours later.
20kg to less than 30kg: less than or equal to 2g per day, in two divided doses at bedtime and 2.5 to 4 hours later.
15kg to less than 20kg: less than or equal to 1g per day, in two divided doses at bedtime and 2.5 to 4 hours later.
Maximum daily dose for children weighing less than 45kg: 0.2g per kg per day.
Maximum daily dose for children weighing 45kg or more: 9g per day.
If the patient sleeps longer than 8 hours per night, sodium oxybate may be given after bedtime, while the child is in bed, in two equally divided doses 2.5 to 4 hours apart.
It is recommended to leave one to two weeks between increments. Body weight should be checked at regular intervals to ensure appropriate dosage is given to children.
Patients with Hepatic Impairment
The starting dose should be halved in patients with hepatic impairment, and the response to dose increments monitored closely.
Additional Dosage Information
If the patient stops medication for more than 14 consecutive days, titration should be restarted from the lowest dose.
The manufacturer suggests if sodium oxybate and sodium valproate are used concomitantly, the sodium oxybate dose should be decreased by 20%. The suggested starting dose for sodium oxybate, when used concomitantly with sodium valproate, is 3.6g per day administered in two equal divided doses of approximately 1.8g. If concomitant use is warranted, patient response and tolerability should be monitored and dose adjusted accordingly.
Contraindications
Children under 7 years
Children weighing less than 15kg
Breastfeeding
Pregnancy
Severe depression
Succinic semialdehyde dehydrogenase deficiency
Precautions and Warnings
Elderly
Obese patients with a BMI greater than 40kg/m2
Restricted sodium intake
Suicidal ideation
Cardiac failure
Epileptic disorder
Hepatic impairment
History of alcohol abuse
History of depression
History of drug misuse
History of seizures
Hypertension
Porphyria
Renal impairment
Respiratory impairment
Sleep apnoea
Reduce dose in patients with hepatic impairment
Sodium content of formulation may be significant
Advise patient not to drive or operate machinery for at least 6 hours
Treatment to be initiated and supervised by a specialist
Must be diluted before use; see product information
Be vigilant for medicines diversion
Investigate patients presenting with faecal or urinary incontinence
May cause respiratory depression
Monitor and discontinue if appropriate if psychiatric or CNS problems occur
Monitor for impaired motor &/or cognitive function especially in elderly
Monitor for mental changes, suicidal depression and antisocial behaviour
Monitor patient for signs and symptoms of respiratory depression
Monitor patient for weight loss
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with a history of depression and/or suicide attempts
Monitor patients with BMI of or greater than 40kg/m2 for sleep apnoea
Potential for drug abuse
Advise patient/carer seek urgent medical advice if thought disorders occurs
Advise patients/carers to seek medical advice if changes in behaviour/mood
May cause dependence
May increase risk of seizure
Patient should be made aware of possible adverse effects on mood/behaviour
Potential for withdrawal symptoms
Advise patient to avoid alcohol during treatment
Advise that effects are potentiated by CNS depressants (including alcohol)
Patients with renal impairment should reduce their sodium intake
Prescribers should be aware that sleep apnoea occurs in up to 50% of patients with narcolepsy. Patients should be assessed for sleep apnoea before treatment begins.
Paediatric patients should have their breath monitored after administration for two hours to assess abnormality in breathing, if abnormal breath is observed, seek medical support and do not administer the second dose. Do not administer if the patient/caregiver is unable to provide careful monitoring.
Confusion, behavioural disturbances and thought disorders, including thoughts of committing violent acts to self and/or others, in patients treated with sodium oxybate require careful and immediate evaluation.
The emergence of depression during treatment requires immediate evaluation. Monitor patients with a history of depression and/or suicidal behaviour.
Episodes of sleepwalking should be fully evaluated and appropriate interventions considered, due to the risk of injury or self harm.
Cataplexy may return at a higher frequency upon discontinuation, or other withdrawal symptoms may occur.
The reduction of sodium intake should be carefully considered in the management of patients with heart failure, hypertension or compromised renal function.
Pregnancy and Lactation
Pregnancy
Sodium oxybate is contraindicated in pregnancy.
The manufacturer does not recommend the use of sodium oxybate during pregnancy. There are limited data on use in human pregnancy, but data from a limited number of exposures in the first trimester indicate a possible increased risk of spontaneous abortions. Limited data indicates no malformative or foeto/neonatal toxicity from exposure in the second and third trimesters. Animal studies have not shown evidence of teratogenicity, but embryolethality was seen in both rat and rabbit studies.
Lactation
Sodium oxybate is contraindicated in breastfeeding.
The manufacturer does not recommend the use of sodium oxybate in breastfeeding women. Changes in sleep patterns have been observed in breast fed infants, which may correspond with the effects of sodium oxybate treatment on the nervous system. Briggs (2015) suggest that waiting 5 hours after the last dose to just before the next dose breastfeeding is acceptable as no clinically significant exposure to the infant is expected due to sodium oxybates rapid rate of metabolism and short half.
Counselling
Patients should be advised that sodium oxybate has a major effect on the ability to drive and operate machinery. Patients should not undertake activities requiring mental alertness for at least 6 hours after administration. When treatment is initiated, patients should observe extreme caution until they know whether this product has any carry over effects the next day.
Patients should be advised to avoid alcohol during treatment.
Advise patient to discard any remaining solution 40 days after first opening.
Side Effects
Abdominal pain
Abnormal thinking
Aggression
Agitation
Amnesia
Anorexia
Anxiety
Arthralgia
Asthenia
Attention disturbances
Back pain
Blurred vision
Bruxism
Cataplexy
Confusion
Convulsions
Decreased appetite
Dehydration
Delusions
Dependence
Depression
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Drowsiness
Dysgeusia
Dyskinesia
Dyspnoea
Enuresis
Faecal incontinence
Falls
Fatigue
Feeling drunk
Hallucinations
Headache
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Increased appetite
Increased blood pressure
Insomnia
Irritability
Loss of balance
Loss of consciousness (transient)
Mania
Muscle cramps
Muscle spasm
Myoclonus
Nasal congestion
Nasopharyngitis
Nausea
Nervousness
Nightmares
Palpitations
Panic attack
Paraesthesia
Paranoia
Peripheral oedema
Pollakiuria
Psychosis
Rash
Respiratory depression
Restless legs
Sedation
Sinusitis
Sleep apnoea
Sleep disturbances
Sleep paralysis
Sleep walking
Snoring
Somnolence
Suicidal tendencies
Sweating
Tremor
Urinary incontinence
Urinary urgency
Urticaria
Vertigo
Violent behaviour
Vomiting
Weight loss
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2015
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Summary of Product Characteristics: Xyrem 500mg/ml oral solution. UCB Pharma Ltd. Revised November 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 10 August 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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