Adult Dosing

• Narcolepsy: 75 mg PO once daily. May be increased to 150 mg once daily at intervals of at least 3 days. Max dose: 150 mg PO once daily.
• Obstructive Sleep Apnea (OSA): 37.5 mg PO once daily. May be increased to 150 mg once daily at intervals of at least 3 days. Max dose: 150 mg PO once daily.
• Avoid administration within 9 hours of planned bedtime because of the potential to interfere with sleep.

Pediatric Dosing

• Safety and efficacy in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea.

• Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days.

Renal Dose Adjustment

• Mild Renal impairmen (eGFR 60-89 mL/min/1.73 m²): No adjustment required.
• Moderate Renal impairment (eGFR 30-59 mL/min/1.73 m²): 37.5 mg PO once daily. May increase to max 75 mg PO once daily after at least 7 days.
• Severe Renal impairment (eGFR 15-29 mL/min/1.73 m²): 37.5 mg PO once daily. Max dose: 37.5 mg once daily.
• End stage renal disease (ESRD): Not recommended.

Geriatric Dosing

• May need to be adjusted based on eGFR in patients over the age of 65 years.

• Blood Pressure and Heart Rate Increases: Measure heart rate and blood pressure prior to initiating and periodically throughout treatment. Control hypertension before and during therapy. Avoid use in patients with unstable cardiovascular disease, serious heart arrhythmias, or other serious heart problems.
• Psychiatric Symptoms: Use caution in treating patients with a history of psychosis or bipolar disorders. Consider dose reduction or discontinuation of solriamfetol if psychiatric symptoms develop.
• Pregnancy: Safety unknown.Uuse not recommended.
• Breastfeeding: Safety unknown. Use not recommended.
• Pediatric: Safety and efficacy in pediatric patients have not been established
• Geriatric: Because of decreased renal function, dosing may need to be adjusted based on eGFR in these patients. Consideration should be given to the use of lower doses and close monitoring

Interactions

• Monoamine Oxidase (MAO) Inhibitors: Do not administer solriamfetol concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAO inhibitors and noradrenergic drugs may increase the risk of a hypertensive reaction. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure
• Drugs that Increase Blood Pressure and/or Heart Rate: Not been evaluated, and such combinations should be used with caution.
• Dopaminergic Drugs: Might result in pharmacodynamic interactions. Interactions with dopaminergic drugs have not been evaluated with solriamfetol. Use caution when concomitantly administering dopaminergic drugs with solriamfetol.

Pregnancy Category:X

Breastfeeding: Safety unknown; there are no data on the presence of solriamfetol or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Ssolriamfetol or its metabolites were present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

• CNS: Disturbances in attention, tremor
• CV: Increased blood pressure and heart rate, palpitation, decreased appetite, chest discomfort, chest pain
• DERM: Sweating, hyperhidrosis
• GI: Constipation, vomiting, thirst, dry mouth, nausea
• NEURO: agitation, anxiety, headache, insomnia
• RESP: Cough, dyspnea

• Mechanism of Action: To improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea is unclear. However, its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI).
• Absorption: 95% absorbed following oral administration; high-fat food delays absorption by 1 hr.
• Distribution: 199 L.
• Protein Binding: 13.3% to 19.4% bound to plasma protein
• Metabolism/Excretion: Minimally metabolized in humans. 95% of the dose excreted in urine as unchanged
• Half-life: 7.1 hrs.

US Trade Name(s)

• Sunosi

US Availability

Sunosi

• TABS: 75 mg, 150 mg

[Outline]

Neurologic

Dopamine-Norepinephrine

ReuptakeIinhibitor (DNRI)