calcium oxybate/magnesium oxybate/potassium oxybate/sodium oxybate

Absorption: Rapidly absorbed; extent of absorption ↓ by a high-fat meal.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Almost entirely biotransformed to carbon dioxide, which is eliminated by expiration; <5% excreted unchanged in urine.

Half-Life: 40 min.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	1.3 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Concurrent alcohol, CNS depressant, or sedative/hypnotic therapy;
Succinic semialdehyde dehydrogenase deficiency.

Use Cautiously in:

Hepatic impairment (↓ starting dose by 50%);
History of depression or suicidal attempt;
Obstructive sleep apnea;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Children < 7 yr or <20 kg (safety and effectiveness not established);
Geri: ↑sensitivity of drug's effects in older adults; dose ↓ may be required.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: ↑sweating

GI: nausea, vomiting, diarrhea, dry mouth

GU: enuresis

Metab: ↓appetite, weight loss

MS: muscle spasm

Neuro: dizziness, headache, aggression, agitation, anxiety, confusion, depression, hallucinations, irritability, paranoia, paresthesia, psychosis, sedation, SEIZURES, sleep walking, SUICIDAL THOUGHTS/BEHAVIORS, tremor

Resp: RESPIRATORY DEPRESSION

Misc: fatigue,

physical dependence

Interactions ⬆ ⬇

Drug-drug:

↑risk of respiratory depression, hypotension, CNS depression, syncope, and death when used with other CNS depressants, including alcohol, antidepressants, antipsychotics, benzodiazepines, muscle relaxants, opioids, or sedative/hypnotics; concurrent use contraindicated.
Valproic acid may ↑ levels and risk of toxicity; ↓ dose by ≥20% when starting valproic acid; use lower starting dose when initiating therapy in patient already receiving valproic acid.

Route/Dosage ⬆ ⬇

PO (Adults and Children ≥7 yr and ≥45 kg): 2.25 g at bedtime and 2.25 g 2.5–4 hr later (total nightly dose = 4.5 g); may be ↑ at weekly intervals by 1.5 g/night (0.75 g/dose) (max dose = 9 g/night [4.5 g/dose]).
PO (Children ≥7 yr and 30–44.9 kg): 1.5 g at bedtime and 1.5 g 2.5–4 hr later (total nightly dose = 3 g); may be ↑ at weekly intervals by 1 g/night (0.5 g/dose) (max dose = 7.5 g/night [3.75 g/dose]).
PO (Children ≥7 yr and 20–29.9 kg): 1 g at bedtime and 1 g 2.5–4 hr later (total nightly dose = 2 g); may be ↑ at weekly intervals by 1 g/night (0.5 g/dose) (max dose = 6 g/night [3 g/dose]).

Hepatic Impairment

PO (Adults and Children ≥7 yr and ≥45 kg): ↓starting dose by 50% (1.12 g at bedtime and 1.12 g 2.5–4 hr later) (total nightly dose = 2.25 g); dose increments should be titrated to desired effect with close monitoring.

Hepatic Impairment

PO (Children ≥7 yr and 30–44.9 kg): ↓starting dose by 50% (0.75 g at bedtime and 0.75 g 2.5–4 hr later) (total nightly dose = 1.5 g); dose increments should be titrated to desired effect with close monitoring.

Hepatic Impairment

PO (Children ≥7 yr and 20–29.9 kg): ↓starting dose by 50% (0.5 g at bedtime and 0.5 g 2.5–4 hr later) (total nightly dose = 1 g); dose increments should be titrated to desired effect with close monitoring.

Availability ⬆ ⬇

Oral solution: 500 mg/mL

Assessment ⬆ ⬇

Monitor for CNS depression (respiratory depression, hypotension, profound sedation, syncope) and ↑ apnea (sleep-related apnea). Implement immediate medical interventions if symptoms occur.
Monitor for emergent or ↑ depression (depressed mood), suicidal ideation, and suicidal tendencies.
Assess for seizure activity (myoclonus and tonic-clonic).
Assess for confusion, agitation, anxiety, confusion, irritability, panic attack, tension, visual hallucinations, aggression, paranoia, and psychosis. Implement safety precautions.
Evaluate for episodes of sleepwalking. May cause parasomnias (abnormal dreams, night terrors, sleep paralysis, sleep talking, somnambulism).
Monitor patients closely with history of drug abuse for signs of misuse or abuse (↑ in size or frequency of dosing, drug-seeking behavior, feigned cataplexy).

Implementation ⬆ ⬇

REMS: Xywav is available only through a restricted distribution program called the Xywav and XYREM REMS because of the risks of CNS depression, abuse, and misuse. Health care providers are specially certified to prescribe Xywav, and it can only be dispensed by the central pharmacy that is specially certified. Xywav will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe use. Further information is available at www.XYWAVXYREMREMS.com or 1-866-997-3688.
PO: Administer without food and >2 hr after eating, while sitting up in bed. After taking dose, lie down and do not get out of bed. If dosing twice nightly, set an alarm to awaken for the 2nd dose; take ≥2.5–4 hr after 1st dose. Prepare both doses before bedtime.
- Dilute required amount of oral solution in ¼ cup (60 mL) of water in pharmacy-provided container. Consume prepared solution within 24 hr at room temperature.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. If the second dose is missed, that dose should be skipped and should not be taken again until the next night. Two doses should never be taken at one time. If the nightly dose requires multiple administrations, inform patient on how to prepare each dose and to administer while in bed.
Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care provider before taking other medications.
Advise patients they will often fall asleep within 5–15 min of taking the medication, depending on the individual; may vary from night to night.
Instruct patients and/or caregivers to contact a health care provider immediately if the patient develops depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, psychomotor agitation or retardation, ↑ fatigue, feelings of guilt or worthlessness, slowed thinking, impaired concentration, or suicidal ideation.
Advise patients not to engage in hazardous occupations or activities requiring complete mental alertness or motor coordination, such as operating machinery or a motor vehicle or flying an airplane, for ≥6 hr after dose.
Inform patients and/or caregiver about sleepwalking and behavioral or psychiatric adverse reactions, including confusion, anxiety, and psychosis. Notify their health care provider if any of these types of symptoms occur.
Advise patient to avoid alcohol and sedative hypnotics.
REMS: Instruct the patient and/or caregiver about the risk of CNS depression, abuse, and misuse. Educate on how to take safely and effectively. Xywav is available only by prescription and filled through the central pharmacy certified in the XYWAV and XYREM REMS. Instruct the patient they must be enrolled in the XYWAV and XYREM REMS to receive Xywav.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding.

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Contr. Subst. Schedule ⬆