Sunosi (Solriamfetol) Approved for Excessive Daytime Sleepiness in Adults

March 28, 2019

Solriamfetol is approved for adult patients suffering from the effects of narcolepsy and OSA. 

Sunosi (solriamfetol) is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat excessive daytime sleepiness in adults.

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The once-daily oral tablet is to be taken upon awakening and should be avoided within 9 hours of planned bedtime to avoid interference with sleep. Though solriamfetol is indicated for patients suffering from fatigue due to narcolepsy or obstructive sleep apnea (OSA), it is not intended to treat underlying airway obstruction in OSA. It is recommended that the patient's airway is treated with continuous positive airway pressure for at least one month prior to beginning to take solriamfetol. Patients should also maintain treatment for OSA while taking solriamfetol.

Page 2: Prescribing Information

Prescribing Information 

Indications: adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)

Dosage:

  • Once daily upon awakening, avoid use within 9 hours of intended bedtime

  • Narcolepsy starting dose: 75 mg once daily

  • OSA starting dose: 37.5 mg once daily

  • Doses may be increased in three-day intervals, maximum being 150 mg daily

  • For patients with renal impairment:
  • Starting dose: 37.5 mg once daily

  • Maximum: 75 mg once daily after 7 days

  • Severe impairment: 37.5 mg once daily

  • Not recommended for patients with end stage renal disease

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

 

Full Prescribing Information