A well-established safety and tolerability profile

Discontinuation due to adverse reactions in the 12-week studies1

SUNOSI (all doses; N=396)
3% (n=11)
Placebo (N=226)
<1% (n=1)

The adverse reactions resulting in discontinuation that occurred in more than 1 SUNOSI-treated patient and at a higher rate than placebo were anxiety, palpitations, and restlessness (each 2/396; <1%).

Most common adverse reactions1

The most common adverse reactions (≥5% and greater than placebo) reported more frequently with SUNOSI were headache, nausea, decreased appetite, anxiety, and insomnia.

Dose-dependent adverse reactions ≥2% in patients treated with SUNOSI and greater than placebo in pooled, 12-week, placebo-controlled studies1


*In OSA only.
“Headache” includes headache, tension headache, and head discomfort.
“Nausea” includes nausea and vomiting.



Adverse reactions ≥2%
in patients treated with SUNOSI
and greater than placebo in pooled,
12-week, placebo-controlled
narcolepsy studies1


*“Insomnia” includes insomnia, initial insomnia, middle insomnia, and terminal insomnia.
“Anxiety” includes anxiety, nervousness, and panic attack.
“Headache” includes headache, tension headache, and head discomfort.
§“Nausea” includes nausea and vomiting.



Adverse reactions ≥2%
in patients treated with SUNOSI
and greater than placebo in pooled,
12-week, placebo-controlled
OSA studies1


*“Anxiety” includes anxiety, nervousness, and panic attack.
“Nausea” includes nausea and vomiting.
“Abdominal pain” includes abdominal pain, abdominal pain upper, and abdominal discomfort.

Drug interactions

Pharmacodynamic drug interactions1

Monoamine oxidase (MAO) inhibitors

Concomitant use of MAO inhibitors and noradrenergic drugs may increase the risk of a hypertensive reaction.

  • Do not administer SUNOSI concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment
  • Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure

Drugs that increase blood pressure and/or heart rate

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

Dopaminergic drugs

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

Pharmacokinetic drug interactions are unlikely to occur1

  • Not metabolized by the liver
  • Not an inhibitor of major metabolizing (CYP) enzymes or renal transporters
  • Predominantly excreted unchanged in the urine
  • Undergoes minimal metabolism in humans
  • Shows low plasma protein binding
  • SUNOSI is contraindicated in patients receiving concomitant treatment with MAOIs, or within 14 days following discontinuation of an MAOI, because of the risk of hypertensive reaction

A low potential for abuse and low risk of dependence

Low potential for abuse1,2

  • SUNOSI is a Schedule IV
     

    What does Schedule IV mean?2

    • Per the US Drug Enforcement Administration, drug scheduling is based on acceptable medical use and potential for abuse or dependence
    • There are 5 schedules, with Schedule I drugs having the highest potential for abuse and dependence and Schedule V drugs having the lowest
    • Schedule IV drugs have a low risk of abuse and dependence
    Sunosi drug scheduling scale

    United States Drug Enforcement Administration, https://www.dea.gov/drug-scheduling

    drug
  • The abuse potential of SUNOSI was shown to be similar to or lower than that of the Schedule IV stimulant phentermine—even at doses 8 times the maximum recommended daily dose
  • Physicians should carefully evaluate patients for a 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

No evidence of tolerance, dependence, or withdrawal1,3

  • In clinical studies, efficacy was seen as early as week 1 and was consistent at week 12, suggesting that tolerance to SUNOSI did not develop
  • After at least 6 months of treatment, there was no evidence that abrupt discontinuation of SUNOSI resulted in adverse events suggestive of physical dependence or withdrawal

Blood pressure and heart rate increases1

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, preexisting 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 may be at a higher risk of increases in blood pressure and heart rate because of the prolonged half-life of SUNOSI.

Maximal mean changes in blood pressure and heart rate assessed at MWT sessions from baseline through week 12: mean (95% CI)1*

Changes in blood pressure and heart rate assessed at MWT test sessions chart Changes in blood pressure and heart rate assessed at MWT test sessions Sunosi chart

SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate.

*For study weeks 1, 4, and 12, SBP, DBP, and HR were assessed pre-dose and every 1-2 hours for 10 hours after test drug administration. For all time points at all visits, the mean change from baseline was calculated, by indication and dose, for all patients with a valid assessment. The table shows, by indication and dose, the mean changes from baseline for the week and time point with the maximal change in SBP, DBP, and HR.


Blood pressure and heart rate by 24-hour ambulatory monitoring: mean change (95% CI) from baseline at week 81

Blood pressure and heart rate by 24 hour ambulatory monitoring chart Blood pressure and heart rate by 24 hour ambulatory monitoring chart

SBP = systolic blood pressure; DBP = diastolic blood pressure; HR = heart rate.

*Number of patients who had at least 50% valid ABPM readings.

Dopamine-norepinephrine reuptake inhibitor mechanism of action

SUNOSI is a dual-acting
treatment
for EDS in
narcolepsy and OSA

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Proven effective
across 4 clinical studies

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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. Drug Scheduling. United States Drug Enforcement Administration website. https://www.dea.gov/drug-scheduling. Accessed March 19, 2019.
  3. Data on File (SOL-2018-066). Palo Alto, CA: Jazz Pharmaceuticals, Inc.