SUNOSI for excessive daytime sleepiness (EDS) due to OSA:
Proven efficacy across multiple key clinical measures1
CO-PRIMARY ENDPOINT
SUNOSI 150 mg significantly reduced daytime sleepiness2,3
Co-primary endpoint was least squares mean change from baseline to week 12 in Epworth Sleepiness (ESS) scores2,3
ESS is scored from 0 to 24. A score of >10 indicates EDS. Reducing ESS scores indicates EDS improvement.4
In a post hoc analysis, over 70% of patients achieved sleepiness levels in the normative range (ESS ≤10) with SUNOSI 150 mg at week 125†
EDS=excessive daytime sleepiness; ESS=Epworth Sleepiness Scale; LS=least squares; OSA=obstructive sleep apnea.
*Percent change from baseline to week 12 was calculated as the within group least squares mean change from baseline to week 12 divided by the overall baseline mean times 100.
†Results are based on a post hoc analysis of ESS scores from the 12-week, placebo-controlled TONES 3 study.5
CO-PRIMARY ENDPOINT
Improvements in wakefulness seen as early as week 1 and sustained through week 121,2
Co-primary endpoint was least squares mean change from baseline to week 12 in mean sleep latency during the Maintenance of Wakefulness Test (MWT)2,3
Patients taking SUNOSI experienced rapid wakefulness in as early as 1 hour, lasting 9 hours, as measured at week 121
LS=least squares.
*Percent change from baseline to week 12 was calculated as the within group least squares mean change from baseline to week 12 divided by the overall baseline mean times 100. Seven patients were missing baseline values and were not included in the percent change from baseline.3
KEY SECONDARY ENDPOINT
Nearly all patients on SUNOSI 150 mg reported feeling better2
Patient Global Impression of Change (PGIC) improvement measured at week 122*
*The percentage of patients improved on the PGIC scale includes those who reported very much, much, and minimal improvement.2
IN A LONG-TERM MAINTENANCE STUDY OF EFFICACY AND SAFETY IN ADULTS WITH EDS IN OSA AND NARCOLEPSY
SUNOSI maintained reductions in daytime sleepiness6
After 6 months, patients taking SUNOSI maintained reductions in daytime sleepiness compared to patients who worsened when switched to placebo6*
EDS=excessive daytime sleepiness; ESS=Epworth Sleepiness Scale; LS=least squares; OSA=obstructive sleep apnea.
*The maintenance of the effect of SUNOSI was measured by change in ESS scores from the beginning to the end of the randomized-withdrawal period in a placebo-controlled, randomized-withdrawal study following 6 months of open-label use. Results represent OSA and narcolepsy pooled data for 75-mg, 150-mg, and 300-mg doses of SUNOSI. The maximum recommended dose is 150 mg once daily.1,6
†Values shown are for parent study baseline in Group A (15.9) and baseline in the current study for Group B (16.2). The start of randomized withdrawal was 27 weeks for Group A and 26 weeks for Group B.6
Functional outcomes and QoL secondary endpoints in TONES 3
Changes in functional outcomes measures with SUNOSI across daily life, work, and well-being7
Patient-reported results at week 12
Functioning and ability to perform daily activities
LS mean change from
baseline in FOSQ-10 total score
Overall work impairment
LS mean percent change from
baseline in WPAI:SHP score-
overall work impairment
Physical and mental well-being
LS mean change from
baseline in SF-36v2 score
LS mean change from
baseline in SF-36v2 score
Placebo
(n=114)
37.5 mg
(n=56)
75 mg
(n=58)
150 mg
(n=116)
Analyses were not controlled for multiplicity. No conclusions should be drawn regarding treatment differences between groups.
FOSQ-10=Functional Outcomes of Sleep Questionnaire short version; LS=least squares; QOL=quality of life; SF-36v2=36-item Short Form Health Survey version 2; WPAI:SHP=Work Productivity and Activity Impairment Questionnaire: Specific Health Problem.
SUNOSI may be an option for patients with OSA who have unresolved EDS despite CPAP compliance1,8
In the 12-week, placebo-controlled study of patients with EDS in OSA1:
- SUNOSI did not impact adherence to primary airway therapy1*†‡
- Efficacy was similar regardless of baseline airway therapy adherence based on a post hoc analysis. Clinical conclusions cannot be drawn9
SUNOSI can help treat the EDS that many patients experience despite using CPAP1,8,9
CPAP=continuous positive airway pressure; EDS=excessive daytime sleepiness; OSA=obstructive sleep apnea.
*Adherence was defined as ≥4 hours per night on ≥70% of nights based on hourly usage data or daily diary, or history of a surgical intervention for OSA. At baseline, 73% of patients were adherent to primary airway therapy.9
†Use of primary airway therapy was similar between placebo and SUNOSI treatment groups and did not change across the study in any treatment group.1
‡In the study, patients were instructed not to change their adherence to primary airway therapy.9
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATION
SUNOSI is indicated to improve wakefulness in adults with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).
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.
Blood Pressure and Heart Rate Increases (Cont’d)
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).
SUN HCP ISI 05/2022
Please see full Prescribing Information.
REFERENCES:
- SUNOSI (solriamfetol) [prescribing information]. New York, NY: Axsome Therapeutics, Inc.
- Schweitzer PK, Rosenberg R, Zammit GK, et al. Solriamfetol for excessive sleepiness in obstructive sleep apnea (TONES 3): a randomized controlled trial. Am J Respir Crit Care Med. 2019;199(11):1421-1431.
- Data on File (SOL-2020-086). New York, NY: Axsome Therapeutics, Inc.
- Johns MW. About the ESS. The Epworth Sleepiness Scale. Accessed January 10, 2025. https://epworthsleepinessscale.com/about-the-ess/
- Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021;17(4):711-717.
- Malhotra A, Shapiro C, Pepin JL, et al. Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea. Sleep. 2020;43(2):1-11.
- Weaver TE, Drake CL, Benes H, et al. Effects of solriamfetol on quality-of-life measures from a 12-week phase 3 randomized controlled trial. Ann Am Thorac Soc. 2020;17(8):998-1007.
- 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.
- Schweitzer PK, Mayer G, Rosenberg R, et al. Randomized controlled trial of solriamfetol for excessive daytime sleepiness in OSA: an analysis of subgroups adherent or nonadherent to OSA treatment. Chest. 2021;160(1):307-318.