Sunosi From Jazz Pharmaceuticals, Inc

The FDA has approved Sunosi (solriamfetol) from Jazz Pharmaceuticals, Inc, to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA).

The approval carries the limitations that Sunosi is not indicated to treat the underlying airway obstruction in OSA, which should be treated for at least 1 month before beginning Sunosi and treatment continuing throughout use of the medication. Sunosi is a schedule IV controlled substance.^1,2

PHARMACOLOGY AND PHARMACOKINETICS

Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor. It exhibits linear kinetics and reaches peak plasma concentrations about 2 hours after administration. Sunosi has an elimination half-life of about 7.1 hours.^1,2

DOSAGE AND ADMINISTRATION

Sunosi should be taken by mouth upon awakening with or without food. Its administration should be avoided within 9 hours of planned bedtime, as it may interfere with sleep if taken too late in the day. The recommended dose range for patients with narcolepsy is 75 to 150 mg once daily, with the initial dose beginning at 75 mg daily and increasing to 150 mg after at least 3 days. The recommended dose range for patients with OSA is 37.5 to 150 mg once daily, with treatment initiating at 37.5 mg once daily and doubling at intervals of at least 3 days to a maximum of 150 mg once daily based on efficacy and tolerability. Patients with moderate renal impairment should begin treatment with 37.5 mg once daily and may increase to a maximum of 75 mg once daily after at least 7 days. For patients with severe renal impairment, the starting and maximum dose is 37.5 mg once daily. Sunosi should not be used in patients with endstage renal disease.¹

CLINICAL TRIALS

The efficacy of Sunosi in narcolepsy was demonstrated in a 12-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled study in which participants using Sunosi 150 mg demonstrated statistically significant improvements in wakefulness compared with those using a placebo. The efficacy of Sunosi in patients with OSA was demonstrated in a 12-week double-blind, multicenter, placebocontrolled, randomized study that found that participants using Sunosi 37.5, 75, and 150 mg showed statistically significant improvements in their sleepiness assessment scores and wakefulness compared with participants using a placebo.

The maintenance of effect of Sunosi in adults with narcolepsy and OSA was evaluated in 2 trials, Study 3 and Study 4. Study 3 was a 6-week, double-blind, multicenter, placebo-controlled, randomized-withdrawal study of adults with OSA in which participants were randomized to either continue treatment with Sunosi or receive a placebo. The study found that the placebo group experienced statistically significant worsening of sleepiness than the group who continued treatment. Study 4 was a 52-week, open-label study of patients with either narcolepsy or OSA who had previously completed a clinical trial with Sunosi. After 6 months of stable-dose treatment, participants were randomized to either continue treatment with Sunosi or receive a placebo. The study found that participants using a placebo experienced statistically significant worsening of sleepiness compared with those using Sunosi.^1,2

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS

The use of Sunosi is contraindicated in patients who are using a monoamine oxidase inhibitor (MAOI) or who have used an MAOI within the preceding 14 days.

Because Sunosi causes dose-dependent increases in diastolic blood pressure (BP), heart rate, and systolic BP, BP should be assessed and hypertension controlled before beginning treatment. BP should be monitored regularly, and exacerbations of preexisting hypertension and new-onset hypertension should be treated appropriately. Caution should be used during the treatment of patients of advanced age or those with known cardiovascular disease (CVD), cerebrovascular disease, or preexisting hypertension. Sunosi should not be used in patients with serious heart arrhythmias, unstable CVD, or other serious heart problems. Caution should be used during the treatment of patients with a history of bipolar disorders or psychosis. A dose reduction or a discontinuation of Sunosi should be considered if psychiatric symptoms develop during treatment. Caution should be used if Sunosi is administered in combination with other dopaminergic agents or with medications that increase BP and/or heart rate.

The most common adverse reactions (≥5% and greater than the placebo) are anxiety, decreased appetite, headache, insomnia, and nausea.¹

Monica Holmberg, PharmD, BCPS, earned her PharmD at the University of Connecticut in Storrs and completed an ambulatory care residency at the Phoenix VA Health Care System in Arizona. Her practice has also included pediatrics and inpatient mental health. She lives in Phoenix.

REFERENCES

• Sunosi [prescribing information]. Palo Alto, CA: Jazz Pharmaceuticals Inc; 2019. pp.jazzpharma.com/pi/sunosi.en.USPI.pdf. Accessed August 9, 2019.
• Jazz Pharmaceuticals announces U.S. FDA approval of Sunosi (solriamfetol) for excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea [news release]. Dublin, Ireland: Jazz Pharmaceuticals Inc; March 20, 2019. investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-us-fda-approval-sunositm. Accessed August 9, 2019.