HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useSUNOSI™ safely and effectively. See full prescribing information forSUNOSI.
SUNOSI(solriamfetol)tablets, for oral use, [controlled substance
schedule pending]
Initial U.S. Approval: [pending controlled substance scheduling]
INDICATIONS AND USAGE
SUNOSI 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). (1)
Limitations of Use
SUNOSI is not indicated to treat the underlying airway obstruction in OSA.
Ensure that the underlying airway obstruction is treated (e.g., with continuouspositive airway pressure (CPAP)) for at least one month prior to initiating
SUNOSI for excessive daytime sleepiness. Modalities to treat the underlyingairway obstruction should be continued during treatment with SUNOSI.
SUNOSI is not a substitute for these modalities. (1)
DOSAGE AND ADMINISTRATION
Administer once daily upon awakening. Avoid administration within9 hours of planned bedtime because of the potential to interfere withsleep. (2.2)
Starting dose for patients with narcolepsy: 75 mg once daily. (2.3)
Starting dose for patients with OSA: 37.5 mg once daily. (2.4)
Dose may be increased at intervals of at least 3 days. (2.3, 2.4)
Maximum dose is 150 mg once daily. (2.3, 2.4)
Renal impairment (2.5, 8.6, 12.3):
Moderate impairment: Starting dose is 37.5 mg once daily.
o May increase to 75 mg once daily after at least 7 days.
Severe impairment: Starting dose and maximum dose is 37.5 mg
once daily.
End stage renal disease (ESRD): Not recommended.
DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg (functionally scored) and 150 mg. (3)
CONTRAINDICATIONS
Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or use ofan MAOI within the preceding 14 days. (4)
WARNINGS AND PRECAUTIONS
Blood Pressure and Heart Rate Increases: Measure heart rate and bloodpressure prior to initiating and periodically throughout treatment.
Control hypertension before and during therapy. Avoid use in patientswith unstable cardiovascular disease, serious heart arrhythmias, or otherserious heart problems. (5.1)
Psychiatric Symptoms: Use caution in treating patients with a history ofpsychosis or bipolar disorders. Consider dose reduction ordiscontinuation of SUNOSI if psychiatric symptoms develop. (5.2)
ADVERSE REACTIONS
Most common adverse reactions (≥5% and greater than placebo): headache,nausea, decreased appetite, insomnia, and anxiety. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact JazzPharmaceuticals, Inc. at 1-800-520-5568 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that Increase Blood Pressure and/or Heart Rate and Dopaminergic Drugs:
Use caution when co-administering with SUNOSI. (7.2, 7.3)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide
Revised: 03/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Important Considerations Prior to Initiating Treatment
2.2 General Administration Instructions
2.3 Dosage in Narcolepsy
2.4 Dosage in OSA
2.5 Dosage Recommendations in