Effective Date

Date of Origin   

10-01-2024           

01-01-2020

Sunosi®

(solriamfetol)

Tablet

Improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)

Limitations of Use:

Not indicated to treat the underlying airway 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 for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with Sunosi. Sunosi is not a substitute for these modalities.

1

Excessive daytime sleepiness

Excessive daytime sleepiness (EDS) is characterized by persistent sleepiness regardless of how much sleep an individual gets at night. In between sleep attacks, individuals have normal levels of alertness, particularly if doing activities that keep their attention.(2) The most common causes of EDS include narcolepsy, obstructive sleep apnea, shift work disorder, sleep deprivation, medication effects, and other medical and psychiatric conditions.(5)

Narcolepsy

Narcolepsy is a chronic neurological disorder caused by the inability to regulate sleep-wake cycles. At various times throughout the day, patients with narcolepsy experience irresistible bouts of sleep and could fall asleep. If left undiagnosed or untreated, narcolepsy can interfere with psychological, social, and cognitive function and development and can inhibit academic, work, and social activities. Symptoms may include excessive daytime sleepiness, cataplexy, sleep paralysis, and hallucinations. All patients diagnosed with narcolepsy will have excessive daytime sleepiness. However, sleepiness in narcolepsy is more like a “sleep attack”, where an overwhelming sense of sleepiness comes on quickly.(2) There is limited evidence to advise on treatment of special populations such as children, pregnant women, and breastfeeding mothers.(4)

The American Family Physician recommends referral to a sleep clinic if narcolepsy is suspected.(3) The American Academy of Sleep Medicine (AASM) indicates treatment goals should be to alleviate daytime sleepiness and produce the fullest possible return of normal function for patients at work, school, home, and socially.(4)

AASM 2021 guidelines combined the recommendations for narcolepsy with cataplexy and EDS associated with narcolepsy. The AASM recommend the following for the pharmacologic treatment with narcolepsy:(8)

• Strong treatment recommendations:
  • Modafinil
  • Pitolisant
  • Sodium oxybate
  • Solriamfetol
• Conditional treatment recommendations:
  • Armodafinil
  • Dextroamphetamine
  • Methylphenidate
• There was insufficient evidence to make recommendations for SSRI and SNRIs for the treatment of narcolepsy.(8)

Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) is a prevalent condition with serious health consequences, including EDS, cognitive disturbances, depression, hypertension, and cardiovascular and cerebrovascular disease.(7)

Guidelines from the American College of Physicians (ACP) on management of OSA do not include modafinil/armodafinil in their recommendations for treatment. ACP guidelines state that pharmacologic therapy is not currently supported by evidence and should not be prescribed for OSA treatment.(7) AASM practice parameters recommend modafinil in patients with OSA for the treatment of residual excessive daytime sleepiness despite effective positive airway pressure treatment and who are lacking any other identifiable cause for their sleepiness.(7)  Both guidelines recommend weight loss for obese and overweight patients and continuous positive airway pressure treatment as initial therapy.(6,7)

A review on the treatment of OSA suggested pharmacologic agents play a minimal role in the treatment of breathing itself in patients with a sleep disorder. Modafinil and armodafinil are considered adjunctive therapies to improve wakefulness in these patients. These agents are recommended for patients who experience residual sleepiness despite optimal CPAP therapy, provided CPAP compliance is closely monitored. Modafinil or armodafinil do not treat the OSA itself but only the associated symptoms of sleepiness. The majority of patients (75%) with severe sleepiness at baseline still had mean multiple sleep latency times of less than 10 minutes despite the addition of modafinil to effective therapy with CPAP. This suggests that these drugs do not necessarily eliminate the risk of motor vehicle and other accidents in the OSA population. Concern also exists that the use of pharmacotherapy to treat excessive sleepiness associated with OSA may lead to subsequent reduction in CPAP compliance.(6)

Efficacy

Excessive Daytime Sleepiness (EDS) in Patients with Narcolepsy

The efficacy of Sunosi in improving wakefulness and reducing excessive daytime sleepiness was demonstrated in a 12-week, multi-center, randomized, double-blind, placebo controlled, parallel-group study (Study 1; NCT02348593) in adult patients with a diagnosis of narcolepsy according to the ICSD-3 or DSM-5 criteria.(1)

Wakefulness and sleepiness were assessed using the Maintenance of Wakefulness Test(MWT) and the Epworth Sleepiness Scale (ESS). Compared to the placebo group, patients randomized to 150 mg Sunosi showed statistically significant improvements on the MWT and on the ESS at Week 12.(1)

Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)

The efficacy of Sunosi in improving wakefulness and reducing excessive daytime sleepiness in patients with OSA was demonstrated in a 12-week multi-center, randomized, double-blind, placebo-controlled study (Study 2; NCT02348606) in adults diagnosed with OSA according to ICSD 3 criteria.(1)

Compared to the placebo group, patients randomized to 37.5 mg, 75 mg, and 150 mg Sunosi showed statistically significant improvements on the MWT and ESS. At Week 12, 37.5 mg, 75 mg, and 150 mg of Sunosi all demonstrated improvements in wakefulness compared to placebo as assessed in test sessions 1 (approximately 1 hour post-dose) through 5 (approximately 9 hours post-dose) of the MWT.(1)

Safety

Sunosi is contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuation of MOAI, due to the risk of hypertensive reactions.(1)

1

Sunosi prescribing Information. Axsome Therapeutics, Inc. June 2023.

2

National Institute of Neurological Disorders and Stroke. Narcolepsy. NIH Publication No. 17-1637. Available at: https://www.ninds.nih.gov/health-information/disorders/narcolepsy.
Last updated September 2023. Accessed October 2023.

3

Ramar, Kannan MD and Olson, Eric MD. Management of Common Sleep Disorders. Am Fam Physician. 2013 Aug 15; 88(4): 231-238.

4

Krahn, Lois MD, et al. Quality Measures for the Care of Patients with Narcolepsy. Journal of Clinical Sleep Medicine. 2015; Vol. 11(3).

5

Pagel J. Excessive daytime sleepiness. Am Fam Physician. 2009;79(5): 391-395.

6

Qaseem A, Holty J, Owens D, et al. Management of obstructive sleep apnea in adults: A clinical practice guideline from the American College of Physicians.  Ann Intern Med. 2013;159:471–483.

7

Morgenthaler TI, Kapen S, Lee-Chiong T, Alessi C, Boehlecke B, Brown T, et al. Practice parameters for the medical therapy of obstructive sleep apnea. Sleep (2006) 29:1031–5.

8

Maski K, Trotti LM, Kotagal S, et al. Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. J Clin Sleep Med. 2021;17(9):1881-1893.

Sunosi

solriamfetol hcl tab

150 MG ; 75 MG

M ; N ; O ; Y

N

Sunosi

solriamfetol hcl tab

150 MG ; 75 MG

30

Tablets

30

DAYS

Sunosi

solriamfetol hcl tab

150 MG ; 75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Sunosi

solriamfetol hcl tab

150 MG ; 75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Initial Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) AND ALL of the following:
      1. The underlying airway obstruction has been treated (e.g., continuous positive airway pressure [CPAP]) for at least 1-month prior to initiating therapy with the requested agent AND
      2. The modalities to treat the underlying airway obstruction (e.g., continuous positive airway pressure [CPAP]) will be continued during treatment with the requested agent AND
      3. ONE of the following:
         1. The patient has tried and had an inadequate response after 1-month of therapy with armodafinil OR modafinil OR
         2. The patient has an intolerance or hypersensitivity to armodafinil OR modafinil OR
         3. The patient has an FDA labeled contraindication to BOTH armodafinil AND modafinil OR
   2. The patient has a diagnosis of excessive daytime sleepiness associated with narcolepsy AND ONE of the following:
      1. The patient has tried and had an inadequate response after 1-month of therapy with armodafinil OR modafinil OR
      2. The patient has an intolerance or hypersensitivity to armodafinil OR modafinil OR
      3. The patient has an FDA labeled contraindication to BOTH armodafinil AND modafinil AND
2. If the patient has an FDA approved indication, then ONE of the following:
   1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
   2. The prescriber has provided information in support of using the requested agent for the patient’s age for the requested indication AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, psychiatrist, pulmonologist, sleep disorder specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
4. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

Note: If Quantity Limit applies, please refer to Quantity Limit Criteria.

*Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required.

Renewal Evaluation

Target Agent(s) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review]  AND
2. The patient has had clinical benefit with the requested agent AND
3. If the diagnosis is excessive daytime sleepiness associated with obstructive sleep apnea (OSA), the modalities to treat the underlying airway obstruction (e.g., continuous positive airway pressure [CPAP]) will be continued during treatment with the requested agent AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, psychiatrist, pulmonologist, sleep disorder specialist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
5. The patient does NOT have any FDA labeled contraindications to the requested agent

Length of Approval:  12 months

Note: If Quantity Limit applies, please refer to Quantity Limit Criteria. 

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. BOTH of the following: 
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
   3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months