General

Pronunciation:
sol-ri-am-fe-tol

Trade Name(s)

• Sunosi

Ther. Class.

central nervous system stimulants

Pharm. Class.

dopamine norepinephrine reuptake inhibitors

Controlled Substance Schedule: IV

Indications

Excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea.

Action

Selective dopamine and norepinephrine reuptake inhibitor.

Therapeutic Effect(s):

Improved wakefulness.

Pharmacokinetics

Absorption: 95% absorbed following oral administration; high-fat food delays absorption.

Distribution: Extensively distributed to tissues.

Metabolism and Excretion: Undergoes minimal metabolism; primarily excreted in urine as unchanged drug (95%).

Half-life: 7 hr.

TIME/ACTION PROFILE (plasma concentrations)

Contraindication/Precautions

Contraindicated in:

• Concurrent use or use within 14 days of discontinuation of MAO inhibitors;
• End-stage renal disease.

Use Cautiously in:

• Cardiovascular disease, cerebrovascular disease, or hypertension;
• Moderate or severe renal impairment (↓ dose);
• Psychoses or bipolar disorder;
• History of drug (especially stimulants) or alcohol abuse;
• OB:   Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
• Lactation:  Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
• Pedi:   Safety and effectiveness not established in children;
• Geri:  Because of reduced renal function, older adults may be at ↑ risk of adverse reactions.

Adverse Reactions/Side Effects

CV: ↑ BP, ↑ HR, palpitations

Derm: ↑ sweating

GI: ↓ appetite, abdominal pain, constipation, diarrhea, dry mouth, nausea

Neuro: headache, anxiety, dizziness, insomnia, irritability

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

• Concurrent use with or within 14 days of discontinuation of  MAO inhibitors  may ↑ risk of hypertensive crises; concurrent use contraindicated.
• Use cautiously with other  drugs that ↑ BP or HR.
•  Dopaminergic drugs  may have synergistic effects.

Route/Dosage

Narcolepsy

PO (Adults): 75 mg once daily; may ↑ to 150 mg once daily, if needed, after ≥3 days.

Renal Impairment 
PO (Adults): eGFR 30–59 mL/min/1.73 m² :  37.5 mg once daily; may ↑ to 75 mg once daily after ≥7 days, if needed.  eGFR 15–29 mL/min/1.73 m² :  37.5 mg once daily.

Obstructive Sleep Apnea

PO (Adults): 37.5 mg once daily; may double dose at intervals of at least every 3 days, if needed (max dose = 150 mg/day).

Renal Impairment 
PO (Adults): eGFR 30–59 mL/min/1.73 m² :  37.5 mg once daily; may ↑ to 75 mg once daily after ≥7 days, if needed.  eGFR 15–29 mL/min/1.73 m² :  37.5 mg once daily.

Availability

Tablets: 75 mg, 150 mg

Assessment

• Observe and document frequency of narcoleptic episodes before starting and during therapy.
• Assess BP and HR; control hypertension before starting therapy. Monitor BP during therapy and treat new-onset hypertension and exacerbations of pre-existing hypertension.  If ↑ BP or HR that is not managed with dose ↓ or other intervention occurs,  consider discontinuing solriamfetol.
• Assess for emergence or exacerbation of psychiatric symptoms.  If symptoms occur,  consider dose ↓ or discontinuing solriamfetol.

Implementation

• PO Administer upon waking without regard to food.

Patient/Family Teaching

• Explain purpose and side effects of medication. Advise patient to read  Patient Information  before starting therapy.
• Instruct patient to avoid taking medication within 9 hr of planned bedtime; may impair ability to fall asleep.
• Advise patient that sharing this medication with others is dangerous and illegal; Solriamfetol has abuse potential. Caution patient to protect it from theft and store out of sight and reach of children, in a location not accessible by others.
• Advise patient to notify health care provider if anxiety, insomnia, irritability, agitation, or signs of psychosis or bipolar disorders occur.
• Advise patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications. If alcohol is used during therapy, limit to moderate amounts.
• Rep:  Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected or if breastfeeding. Monitor breastfed infants for agitation, insomnia, anorexia, and ↓ weight gain. Encourage pregnant patient to enroll in the registry to monitor outcomes for exposure to solriamfetol during pregnancy by calling 1-877-283-6220 or visiting www.SunosiPregnancyRegistry.com.

Evaluation/Desired Outcomes

Improved ability to stay awake.