Sleep-wake disorders:

Recent Updates:

Monograph added.

Indications for XYWAV:

Cataplexy or excessive daytime sleepiness in patients ≥7yrs of age with narcolepsy.

Adult:

Take on empty stomach. Dilute each dose with 60mL of water. Initially 4.5g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1.5g/night (0.75g/dose) at weekly intervals; usual range: 6–9g/night; max 9g/night. Some patients may respond better with unequal doses. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Transitioning from Xyrem: initiate at same dose (gram for gram) and regimen; titrate as needed. Hepatic impairment: initially 1⁄2 of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xywav dose by at least 20%; if already taking divalproex sodium, start Xywav at lower dose; monitor, adjust accordingly.

Children:

<7yrs: not established. Take on empty stomach. Dilute each dose with 60mL of water. ≥7yrs (<20kg): see full labeling. (20–<30kg): initially ≤2g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1g/night (0.5g/dose) at weekly intervals. Max total dose: 6g/night. (30–<45kg): initially ≤3g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1g/night (0.5g/dose) at weekly intervals. Max total dose: 7.5g/night. (≥45kg): initially ≤4.5g/night in two equally divided doses, at bedtime then again 2.5–4hrs later. May increase by 1.5g/night (0.75g/dose) at weekly intervals. Max total dose: 9g/night. Some patients may respond better with unequal doses. Allow 6hrs before becoming active after last dose. Consider concomitant CNS stimulant use (see full labeling). Transitioning from Xyrem: initiate at same dose (gram for gram) and regimen; titrate as needed. Hepatic impairment: initially 1⁄2 of original dose per night, given in two equally divided doses. Concomitant divalproex sodium: reduce initial Xywav dose by at least 20%; if already taking divalproex sodium, start Xywav at lower dose; monitor, adjust accordingly.

Contraindications:

Concomitant sedative hypnotics or alcohol. Succinic semialdehyde dehydrogenase deficiency.

Boxed Warning:

CNS depression. Abuse and misuse.

Warnings/Precautions:

Risk of CNS depression. Abuse potential (monitor). Respiratory dysfunction. Sleep-related breathing disorders (esp. in men, postmenopausal women not on HRT, obese, or narcolepsy patients). History of depression or suicidal ideation (monitor). Parasomnias. Hepatic impairment. Drug abusers. Elderly. Labor & delivery. Pregnancy. Nursing mothers.

Pharmacologic Class:

Antinarcoleptic (CNS depressant).

Interactions:

See Contraindications. CNS depression potentiated by concomitant other CNS depressants (eg, opioids, benzodiazepines, antidepressants, antipsychotics, general anesthetics, muscle relaxants, sedating antiepileptic drugs). Potentiated by divalproex sodium.

Adverse Reactions:

Headache, nausea, dizziness, decreased appetite, parasomnia, diarrhea, hyperhidrosis, anxiety, vomiting; children also: enuresis, weight decreased; CNS and respiratory depression, sleep-disordered breathing, sleepwalking, depressive symptoms, confusion, anxiety, other behaviorial/psychiatric reactions.

Note:

Only available through the Xywav REMS Program. For more information call (866) 997-3688.

REMS:

YES

Generic Availability:

NO

How Supplied:

Soln—180mL (w. oral measuring syringe)

Pricing for XYWAV

180ml of 0.5g/ml bottle of oral solution (Qty: 1)
Appx. price $5222
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