ge Recommendations in Patients with Renal Impairment
Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2): Initiate dosing at 37.5 mg oncedaily. Based on efficacy and tolerability, dose may be increased to a maximum of 75 mg oncedaily after at least 7 days [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
Severe renal impairment (eGFR 15-29 mL/min/1.73 m2): Administer 37.5 mg once daily.
Themaximum recommended daily dose is 37.5 mg [see Use in Specific Populations (8.6), ClinicalPharmacology (12.3)].
End Stage Renal Disease (eGFR <15 mL/min/1.73 m2): SUNOSI is not recommended for use inpatients with ESRD [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
SUNOSI 75 mg – (75 mg solriamfetol equivalent to 89.3 mg of the hydrochloride salt) darkyellow oblong tablet with "75" debossed on one side and a functional score line on the oppositeside.
SUNOSI 150 mg – (150 mg solriamfetol equivalent to 178.5 mg of the hydrochloride salt)yellow oblong tablet with "150" debossed on one side.
4 CONTRAINDICATIONS
SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase(MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor,because of the risk of hypertensive reaction [see Drug Interactions (7.1)].
5 WARNINGS AND PRECAUTIONS
5.1 Blood Pressure and Heart Rate Increases
SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dosedependentfashion [see Adverse Reactions (6.1)].
Epidemiological data show that chronic elevations in blood pressure increase the risk of majoradverse cardiovascular events (MACE), including stroke, heart attack, and cardiovascular death.
The magnitude of the increase in absolute risk is dependent on the increase in blood pressure andthe underlying risk of MACE in the population being treated. Many patients with narcolepsy andOSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia, andhigh body mass index (BMI).
Assess blood pressure and control hypertension before initiating treatment with SUNOSI.
Monitor blood pressure regularly during treatment and treat new-onset hypertension andexacerbations of pre-existing hypertension. Exercise caution when treating patients at higher riskof MACE, particularly patients with known cardiovascular and cerebrovascular disease, preexistinghypertension, and patients with advanced age. Use caution with other drugs that increaseblood pressure and heart rate [see Drug Interactions (7.2)].
Periodically reassess the need for continued treatment with SUNOSI. If a patient experiencesincreases in blood pressure or heart rate that cannot be managed with dose reduction of SUNOSIor other appropriate medical intervention, consider discontinuation of SUNOSI.
Patients with moderate or severe renal impairment may be at a higher risk of increases in bloodpressure and heart rate because of the prolonged half-life of SUNOSI [see Dosage andAdministration (2.5), Clinical Pharmacology (12.3)].
5.2 Psychiatric Symptoms
Psychiatric adverse reactions have been observed in clinical trials with SUNOSI, includinganxiety, insomnia, and irritability [see Adverse Reactions (6.1)].
SUNOSI has not been eva luated in patients with psychosis or bipolar disorders. Exercise cautionwhen treating pati |
