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SUNOSI

SOLRIAMFETOL

Manufacturer: Axsome Therapeutics, Inc.

Score: 141.0

Quick Summary

SUNOSI (SOLRIAMFETOL) is a dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA). The recommended dosage range for SUNOSI is 75 mg to 150 mg once daily for narcolepsy and 37.5 mg to 150 mg once daily for OSA. SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors or within 14 days following discontinuation of MAOI treatment. Common adverse reactions include headache, nausea, decreased appetite, anxiety, and insomnia.

Key Clinical Findings and Indications

  • SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
  • The mechanism of action of solriamfetol is unclear, but its efficacy could be mediated through its activity as a dopamine and norepinephrine reuptake inhibitor (DNRI)

Important Safety Information

Warning

SUNOSI can increase blood pressure and heart rate, and should be used with caution in patients with hypertension or cardiovascular disease

Contraindications

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

Adverse Reactions

  • Headache
  • Nausea
  • Decreased appetite
  • Anxiety
  • Insomnia

Dosing Recommendations

General Guidance

Dose may be increased at intervals of at least 3 days, with a maximum dose of 150 mg once daily

Narcolepsy

Adult Dose

75 mg once daily

Pediatric Dose

Not established

OSA

Adult Dose

37.5 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SUNOSI during pregnancy
  • Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Nursing Mothers

  • No information available

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established

Geriatric Use

  • No clinically meaningful differences in safety or effectiveness were observed between elderly and younger patients
  • Consideration should be given to the use of lower doses and close monitoring in this population

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