Emerging science suggests that excessive daytime sleepiness (EDS) in OSA may be due to a disruption in neurologic function

Patients with OSA experience CHRONIC INTERMITTENT
HYPOXIA AND SLEEP FRAGMENTATION
1
Chronic intermittent hypoxia and/or sleep disruption may result
in NEURONAL
INJURY
2-4
This may cause
an IMBALANCE IN THE NEUROTRANSMITTERS AND SIGNALING that regulate sleep and
wake3,5
Patients with OSA experience CHRONIC INTERMITTENT HYPOXIA AND SLEEP FRAGMENTATION1
Chronic intermittent hypoxia and/or sleep disruption may result in NEURONAL INJURY2-4
This may cause an IMBALANCE IN THE NEUROTRANSMITTERS AND SIGNALING that regulate sleep and wake3,5

In addition to these causes, EDS in OSA may be due to other factors such as chronic sleep loss and comorbid disorders.6


Maintaining proper signaling and appropriate neurotransmitter levels is
important for a balanced sleep-wake cycle3,5

Dysregulation in neurotransmitters may affect the sleep-wake cycle

While airway therapy is used to treat OSA, excessive daytime sleepiness (EDS) may persist


52% of patients reported excessive daytime sleepiness (EDS) despite any amount of CPAP use 52% of patients reported excessive daytime sleepiness (EDS) despite any amount of CPAP use
1 in 3 patients report excessive daytime sleepiness (EDS) despite 5 hours nightly CPAP 1 in 3 patients report excessive daytime sleepiness (EDS) despite 5 hours nightly CPAP

*In a study of 174 patients with moderate to severe OSA using continuous positive airway pressure (CPAP). Daytime sleepiness was assessed before and after 3 months of CPAP therapy using the Epworth Sleepiness Scale.6

 
Michael - excessive daytime sleepiness (EDS) associated with OSA

I'm so sleepy that just making it through a typical day is tough. I've dozed off at my desk a few times. What else can I do?

Michael is not an actual patient, but a representation of a patient living with OSA-associated EDS.

  • Uses CPAP every night for 5 to 6 hours
  • Has taken a wake-promoting agent in the past
  • Has had his CPAP adjusted twice and lost weight to achieve a healthier body mass index (BMI)

Recognizing excessive daytime sleepiness (EDS) may be challenging

2 clinical measures can help identify EDS:

  • Subjective, self-reported assessment; simple for patients to complete
  • Measures (on a scale of 0 to 3) a patient's recent likelihood of falling asleep during 8 everyday activities
  • Can be used to assess sleepiness over time and response to treatment
Download the ESS

  • Objective evaluation conducted in a sleep lab
  • Measures the ability to stay awake in a darkened, quiet environment using mean sleep latency (time to sleep onset)
  • Consists of four to five 40-minute trials, conducted at 2-hour intervals over the course of 1 day

The American Thoracic Society recommends routinely asking patients with OSA about their sleepiness and educating them about the risks associated with EDS9

Diagnosis of EDS in OSA is based on a clinical assessment, which must be made by the treating physician after airway treatment is implemented and all other causative disorders have been ruled out, including other untreated sleep disorders, mental disorders, or the effects of medications.10

Coworkers talking - SUNOSI proven effective across 4 clinical studies

Proven effective
across 4 clinical studies

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Woman with excessive daytime sleepiness (EDS) associated with narcolepsy

EDS is a signature
symptom of
narcolepsy

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Part of a comprehensive
approach
to EDS in OSA

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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. Obstructive sleep apnea. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090. Accessed March 19, 2019.
  2. Schwartz JRL, Roth T. Neurophysiology of sleep and wakefulness: basic science and clinical implications. Curr Neuropharmacol. 2008;6(4):367-378.
  3. Zhu Y, Fenik P, Zhan G, et al. Selective loss of catecholaminergic wake–active neurons in a murine sleep apnea model. J Neurosci. 2007;27(37):10060-10071.
  4. Xiong Y, Zhou XJ, Nisi RA, et al. Brain white matter changes in CPAP-treated obstructive sleep apnea patients with residual sleepiness. J Magn Reson Imaging. 2017;45(5):1371-1378.
  5. Zhu Y, Fenik P, Zhan G, Xin R, Veasey SC. Degeneration in arousal neurons in chronic sleep disruption modeling sleep apnea. Front Neurol. 2015;6:109.
  6. Antic NA, Catcheside P, Buchan C, et al. The effect of CPAP in normalizing daytime sleepiness, quality of life, and neurocognitive function in patients with moderate to severe OSA. Sleep. 2011;34(1):111-119.
  7. 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.
  8. SUNOSI (solriamfetol) [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2019.
  9. Strohl KP, Brown DB, Collop N, et al; on behalf of ATS Ad Hoc Committee on Sleep Apnea, Sleepiness, and Driving Risk in Noncommercial Drivers. An official American Thoracic Society clinical practice guideline: sleep apnea, sleepiness, and driving risk in noncommercial drivers: an update of a 1994 statement. Am J Respir Crit Care Med. 2013;187(11):1259-1266.
  10. Chapman JL, Serinel Y, Marshall NS, Grunstein RR. Residual daytime sleepiness in obstructive sleep apnea after continuous positive airway pressure optimization: causes and management. Sleep Med Clin. 2016;11(3):353-363.