Jazz Pharmaceuticals Receives Schedule IV Designation from DEA for Sunosi™ (solriamfetol)
Beginning early July, once-daily Sunosi will be commercially available in the U.S. in 75 mg and 150 mg tablets.
"Excessive daytime sleepiness can have a significant impact on the lives of people with narcolepsy or OSA. With this scheduling decision, we move closer to commercial availability of Sunosi, which can improve wakefulness throughout the day in these patients," said
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Sunosi is 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. Sunosi is not a substitute for these modalities, and the treatment of the underlying airway obstruction should be continued.
More information about Sunosi, including Full Prescribing Information and Medication Guide, is available here.
About Sunosi™ (solriamfetol)
Sunosi is a dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adults living with excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea (OSA). In 2014,
Important Safety Information
SUNOSI (solriamfetol) is available in 75 mg and 150 mg tablets and is a federally controlled substance (C-IV) because it contains solriamfetol that can be a target for people who abuse prescription medicines or street drugs. Keep SUNOSI in a safe place to protect it from theft. Never give or sell your SUNOSI to anyone else, because it may cause death or harm them and it is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Before taking SUNOSI, tell your doctor about all of your medical conditions, including if you:
- have heart problems, high blood pressure, kidney problems, diabetes, or high cholesterol
- have had a heart attack or a stroke
- have a history of mental health problems (including psychosis and bipolar disorders), or of drug or alcohol abuse or addiction
- are pregnant or planning to become pregnant. It is not known if SUNOSI will harm your unborn baby
- are breastfeeding or plan to breastfeed. It is not known if SUNOSI passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take SUNOSI.
What are the possible side effects of SUNOSI?
SUNOSI may cause serious side effects, including:
- Increased blood pressure and heart rate. SUNOSI can cause blood pressure and heart rate increases that can increase the risk of heart attack, stroke, heart failure, and death. Your doctor should check your blood pressure before and during treatment with SUNOSI. Your doctor may decrease your dose or tell you to stop taking SUNOSI if you develop high blood pressure that does not go away during treatment with SUNOSI.
- Mental (psychiatric) symptoms including anxiety, problems sleeping (insomnia), irritability, and agitation. Tell your doctor if you develop any of these symptoms. Your doctor may change your dose or tell you to stop taking SUNOSI if you develop side effects during treatment with SUNOSI.
The most common side effects of SUNOSI include:
- decreased appetite
- problems sleeping
These are not all the possible side effects of SUNOSI. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the
About Obstructive Sleep Apnea and Excessive Daytime Sleepiness
Obstructive sleep apnea, commonly referred to as sleep apnea, is a highly prevalent disease (as high as 14% in men and 5% in women) in which excessive daytime sleepiness is a major presenting complaint in many cases.1-4 Positive Airway Pressure (PAP) therapy, with its most common form being Continuous Positive Airway Pressure (CPAP), has been shown to be an effective therapy for sleep apnea that frequently results in improvement in excessive daytime sleepiness in many patients; however, not all patients tolerate CPAP therapy and among those who tolerate CPAP, usage is highly variable. Excessive daytime sleepiness may persist in people with sleep apnea despite using CPAP.
Narcolepsy is a chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, and the inability to regulate sleep-wake cycles normally.5 It affects an estimated one in 2,000 people in
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements, including, but not limited to, statements related to the potential benefits of Sunosi, the expected timing of commercial availability of Sunosi in the U.S., and other statements that are not historical facts. These forward-looking statements are based on the company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: the company's ability to effectively commercialize Sunosi in the U.S.; delays or problems in the supply or manufacture of Sunosi; obtaining and maintaining appropriate pricing and reimbursement for Sunosi; complying with applicable U.S. regulatory requirements; and other risks and uncertainties affecting the company, including those described from time to time under the caption "Risk Factors" and elsewhere in
1. Sleepfoundation.org. (2019). Sleep Apnea |
3. Peppard AE, et al. Increased Prevalence of Sleep-Disordered Breathing in Adults. Am J Epidemiol. 2013;177(9):1006-1014.
4. Ye, L. (2014). The different clinical faces of obstructive sleep apnoea: a cluster analysis.
5. Thorpy, M. and Krieger, A. (2014). Delayed diagnosis of narcolepsy: characterization and impact. Sleep Medicine, 15(5), pp.502-507.
6. Ahmed I, Thorpy, M. Clinical Features, Diagnosis and Treatment of Narcolepsy. Clin Chest Med. 2010;31(2):371-381.
7. Morrish E, King M, et al. Factors associated with a delay in the diagnosis of narcolepsy. Sleep Medicine. 2004;5(1):37-41.
8. Sateia, M. (2014). International Classification of Sleep Disorders-Third Edition. Chest, 146(5), pp.1387-1394.
9. Ahmed I, Thorpy, M. Sleepiness: Causes, Consequences and Treatment, ed. Cambridge
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