Proven results across 3 key clinical measures

Demonstrated improvements in wakefulness, as measured by the Maintenance of Wakefulness Test (MWT)1,2


SUNOSI efficacy in narcolepsy associated excessive daytime sleepiness - Maintenance of Wakefulness Test (MWT) results
  • Improvement seen as early as week 11,2
  • At week 12, there was an increase from baseline in the average time participants were able to remain awake during the 40-minute MWT trials1,2

Patients randomized to 75 mg showed a trend toward improvement; however, this change was not statistically significant.1

Demonstrated reductions in patient-reported daytime sleepiness, as measured by the Epworth Sleepiness Scale (ESS) at week 121,2


SUNOSI efficacy in narcolepsy associated excessive daytime sleepiness - Epworth Sleepiness Scale (ESS) results graph sunosi efficacy narcolepsy excessive daytime sleepiness ess graph

Patients randomized to 75 mg showed a trend toward improvement; however, this change was not statistically significant.1

Demonstrated patient-reported improvement in symptoms, as measured by the Patient Global Impression of Change (PGIC) scale at week 122*


SUNOSI efficacy in narcolepsy with excessive daytime sleepiness - Patient Global Impression of Change (PGIC) results

*The percentage of patients improved on the PGIC includes those who reported very much, much, and minimal improvement.2

Patients randomized to 75 mg showed a trend toward improvement; however, this change was not statistically significant.1

Demonstrated long-term maintenance of effect1,4

  • The maintenance of effect of SUNOSI was assessed in a placebo-controlled, randomized-withdrawal study following 6 months of open-label use4
  • After 6 months of open-label SUNOSI treatment, a subset of patients entered a 2-week randomized-withdrawal period, during which some patients remained on SUNOSI while others were switched to placebo4

Efficacy was maintained in patients who stayed on SUNOSI, while patients who switched to placebo had a significant worsening in sleepiness, as measured by the ESS1,4


SUNOSI efficacy in narcolepsy associated excessive daytime sleepiness - maintenance of effect graph

SUNOSI was also
proven effective in
patients with OSA

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SUNOSI once-daily dosing

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Doctor and patient - a demonstrated safety profile

A demonstrated
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LIMITATIONS OF USE AND SAFETY INFORMATION

Limitations of Use: SUNOSI is not indicated to treat the underlying obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI. SUNOSI is not a substitute for these modalities, and the treatment of the underlying airway obstruction should be continued.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuation of an MAOI, because of the risk of hypertensive reaction.

WARNINGS AND PRECAUTIONS

Blood Pressure and Heart Rate Increases

SUNOSI increases systolic blood pressure, diastolic blood pressure, and heart rate in a dose-dependent fashion. Epidemiological data show that chronic elevations in blood pressure increase the risk of major adverse 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 and the underlying risk of MACE in the population being treated. Many patients with narcolepsy and OSA have multiple risk factors for MACE, including hypertension, diabetes, hyperlipidemia, and high 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 and exacerbations of pre-existing hypertension. Exercise caution when treating patients at higher risk of MACE, particularly patients with known cardiovascular and cerebrovascular disease, pre-existing hypertension, and patients with advanced age. Use caution with other drugs that increase blood pressure and heart rate.

Periodically reassess the need for continued treatment with SUNOSI. If a patient experiences increases in blood pressure or heart rate that cannot be managed with dose reduction of SUNOSI or other appropriate medical intervention, consider discontinuation of SUNOSI.

Patients with moderate or severe renal impairment could be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of SUNOSI.

Psychiatric Symptoms

Psychiatric adverse reactions have been observed in clinical trials with SUNOSI, including anxiety, insomnia, and irritability.

Exercise caution when treating patients with SUNOSI who have a history of psychosis or bipolar disorders, as SUNOSI has not been evaluated in these patients.

Patients with moderate or severe renal impairment may be at a higher risk of psychiatric symptoms because of the prolonged half-life of SUNOSI.

Observe SUNOSI patients for the possible emergence or exacerbation of psychiatric symptoms. Consider dose reduction or discontinuation of SUNOSI if psychiatric symptoms develop.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions (incidence ≥5%) reported more frequently with the use of SUNOSI than placebo in either narcolepsy or OSA were headache, nausea, decreased appetite, anxiety, and insomnia.

Dose-Dependent Adverse Reactions

In the 12-week placebo-controlled clinical trials that compared doses of 37.5 mg, 75 mg, and 150 mg/day of SUNOSI to placebo, the following adverse reactions were dose-related: headache, nausea, decreased appetite, anxiety, diarrhea, and dry mouth.

DRUG INTERACTIONS

Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment. Concomitant use of MAOIs and noradrenergic drugs may increase the risk of a hypertensive reaction. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure.

Concomitant use of SUNOSI with other drugs that increase blood pressure and/or heart rate has not been evaluated, and combinations should be used with caution.

Dopaminergic drugs that increase levels of dopamine or that bind directly to dopamine receptors might result in pharmacodynamic interactions with SUNOSI. Interactions with dopaminergic drugs have not been evaluated with SUNOSI. Use caution when concomitantly administering dopaminergic drugs with SUNOSI.

USE IN SPECIFIC POPULATIONS

Renal Impairment

Dosage adjustment is not required for patients with mild renal impairment (eGFR 60-89 mL/min/1.73 m2). Dosage adjustment is recommended for patients with moderate to severe renal impairment (eGFR 15-59 mL/min/1.73 m2). SUNOSI is not recommended for patients with end stage renal disease (eGFR <15 mL/min/1.73 m2).

ABUSE

SUNOSI contains solriamfetol, a Schedule IV controlled substance. Carefully evaluate patients for a recent history of drug abuse, especially those with a history of stimulant or alcohol abuse, and follow such patients closely, observing them for signs of misuse or abuse of SUNOSI (e.g., drug-seeking behavior).

INDICATIONS AND USAGE

SUNOSI is indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).

Please see full Prescribing Information.


LIMITATIONS AND SAFETY INFO

LIMITATIONS OF USE AND IMPORTANT SAFETY INFORMATION

Limitations of Use: SUNOSI is not indicated to treat the underlying obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI. SUNOSI is not a substitute for these modalities, and the treatment of the underlying airway obstruction should be continued.

References:
  1. SUNOSI (solriamfetol) [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2019.
  2. Thorpy MJ, Shapiro C, Mayer G, et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol. 2019;85(3):359-370.
  3. Ahmed IM, Thorpy MJ. Clinical evaluation of the patient with excessive sleepiness. In: Thorpy MJ, Billiard M, eds. Sleepiness: Causes, Consequences and Treatment. New York, NY: Cambridge University Press; 2011:36-49.
  4. Malhotra A, Shapiro C, Pepin J-L, et al. A long-term safety and maintenance of efficacy study of solriamfetol (JZP-110) in the treatment of excessive sleepiness in subjects with narcolepsy or obstructive sleep apnea. Poster presented at: 32nd Annual Meeting of the Associated Professional Sleep Societies; June 2-6, 2018; Baltimore, MD.