SOL-ri-AM-fe-tol

Therapeutic Classification: central nervous system stimulants

Pharmacologic Classification:

• Excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea.

• Selective dopamine and norepinephrine reuptake inhibitor.

• Improved wakefulness.

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

Distribution: Extensively distributed to tissues.

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

Half-life: 7 hr.

(plasma concentrations)

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 recommended)
• 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.

CV: ↑ BP, ↑ HR, palpitations.

Derm: ↑ sweating.

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

Neuro: headache, anxiety, dizziness, insomnia, irritability.

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 increase BP or HR.
• Dopaminergic drugs may have synergistic effects.

• PO (Adults): Narcolepsy: 75 mg once daily; may ↑ dose to 150 mg once daily, if needed, after ≥3 days. Obstructive sleep apnea: 37.5 mg once daily; may double dose at intervals of at least every 3 days, if needed (max dose = 150 mg/day).

• Tablets: 75 mg; 150 mg;

• Observe and document frequency of narcoleptic episodes.
• Assess BP and control hypertension before starting therapy. Monitor BP during therapy and treat new-onset hypertension and exacerbations of pre-existing hypertension.

• PO: Administer once daily upon awakening without regard to food.

• Instruct patient to take solriamfetol as directed. Avoid taking medication within 9 hr of planned bedtime; may impair ability to fall asleep.
• Advise patient that sharing this medication with others, even those with same symptoms, is dangerous and illegal. Advise patient that solriamfetol is a drug with known abuse potential. Protect it from theft; store out of sight and reach of children, and in a location not accessible by others.
• Advise patient to notify health care professional if anxiety, insomnia, irritability, agitation, or signs of psychosis or bipolar disorders occur.
• Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications. If alcohol is used during therapy, intake should be limited to moderate amounts.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor breast-fed infants for agitation, insomnia, anorexia and reduced weight gain. Encourage women who become pregnant to enroll in the pregnancy exposure registry to monitor outcomes for women exposed to solriamfetol during pregnancy by calling 1-877-283-6220 or contacting .

• Improved ability to stay awake.

Sunosi

Schedule IV (C-IV)

NDC Code^*

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-350- SUNOSI
    • 68727-350-01- 30 TABLET, FILM COATED in 1 BOTTLE (68727-350-01)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-350- SUNOSI
    • 68727-350-02- 100 TABLET, FILM COATED in 1 BOTTLE (68727-350-02)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-350- SUNOSI
    • 68727-350-07- 7 TABLET, FILM COATED in 1 BLISTER PACK (68727-350-07)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-350- SUNOSI
    • 68727-350-10- 10 TABLET, FILM COATED in 1 CARTON (68727-350-10)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-351- SUNOSI
    • 68727-351-01- 30 TABLET, FILM COATED in 1 BOTTLE (68727-351-01)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-351- SUNOSI
    • 68727-351-02- 100 TABLET, FILM COATED in 1 BOTTLE (68727-351-02)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-351- SUNOSI
    • 68727-351-07- 7 TABLET, FILM COATED in 1 BLISTER PACK (68727-351-07)

• 68727- Jazz Pharmaceuticals, Inc.
  • 68727-351- SUNOSI
    • 68727-351-10- 10 TABLET, FILM COATED in 1 CARTON (68727-351-10)