OVERVIEW

PRODUCT INFORMATION

REPRESENTATIVE TRADE NAMES

Solriamfetol – Sunosi®

DRUG CLASS

CNS Drugs

COMPLETE LABELING

Product labeling at DailyMed, National Library of Medicine, NIH

CHEMICAL FORMULA AND STRUCTURE

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DRUG	CAS REGISTRY NUMBER	MOLECULAR FORMULA	STRUCTURE
Solriamfetol	178429-62-4	C10-H14-N2-O2

ANNOTATED BIBLIOGRAPHY

References updated: 18 August 2021

Abbreviations: DNRI, dopamine and norepinephrine reuptake inhibitor.

• Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999.

  (Review of hepatotoxicity published in 1999 before the availability of solriamfetol).
• FDA. https://www​.accessdata​.fda.gov/drugsatfda_docs​/nda/2019/211230Orig1Orig2s000RiskR.pdf.

  (FDA Drug Approvals website that has product labels [package inserts], letters of approval and full FDA multidisciplinary scientific review of the solriamfetol application for safety and efficacy, which reported that the trials of solriamfetol had no fatalities and no treatment related serious hepatic adverse events).
• Strollo PJ Jr, Hedner J, Collop N, Lorch DG Jr, Chen D, Carter LP, Lu Y, et al. Tones 4 Study Investigators. Solriamfetol for the treatment of excessive sleepiness in OSA: a placebo-controlled randomized withdrawal study. Chest. 2019;155:364–374. [PubMed: 30471270]

  (Among 174 adults with obstructive sleep apnea and excessive daytime sleepiness treated with a dose titration of solriamfetol followed by randomization to continue therapy or switch to placebo, there was clinical improvement on drug and relapse upon withdrawal, adverse events occurring largely during the titration phase [total rate of 49% decreasing to 10.2% during maintenance]; no mention of ALT elevations or hepatotoxicity).
• Thorpy MJ, Shapiro C, Mayer G, Corser BC, Emsellem H, Plazzi G, Chen D, et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol. 2019;85:359–370. [PMC free article: PMC6593450] [PubMed: 30694576]

  (Among 231 patients with narcolepsy and excessive daytime sleepiness treated with solriamfetol [75, 150 or 300 mg] or placebo daily for 12 weeks, both higher doses were associated with improvements achieved within 1 week of starting and maintained thereafter, and while adverse events were more frequent with solriamfetol [68% vs 46%] as were discontinuations [5% to 8.5% vs 1.7%], “no drug-related effects were found on clinical laboratory assessments”).
• Markham A. Solriamfetol: first global approval. Drugs. 2019;79:785–790. [PubMed: 31062265]

  (Review of the mechanism of action, history of development, pharmacology, clinical efficacy, and safety of solriamfetol shortly after its approval for use in the US, mentions the most common symptoms but does not mention ALT elevations or hepatotoxicity).
• Schweitzer PK, Rosenberg R, Zammit GK, Gotfried M, Chen D, Carter LP, Wang H, et al. TONES 3 Study Investigators. Solriamfetol for excessive sleepiness in obstructive sleep apnea (TONES 3). A randomized controlled trial. Am J Respir Crit Care Med. 2019;199:1421–1431. [PMC free article: PMC6835071] [PubMed: 30521757]

  (Among 459 adults with obstructive sleep apnea and excessive daytime sleepiness treated with solriamfetol [37.5, 75, 150 or 300 mg daily] or placebo for 12 weeks, sleepiness scores decreased and wakefulness scores increased, and while total adverse events were more common with solriamfetol, severe adverse events were rare [0.8% vs 1.7% in controls] and “laboratory evaluations did not indicate effects of clinical relevance related to solriamfetol”).
• Solriamfetol (Sunosi) for excessive daytime sleepiness. Med Lett Drugs Ther. 2019;61(1579):132–134. [PubMed: 31581157]

  (Concise review of the mechanism of action, clinical efficacy, safety and cost of solriamfetol for excess sleepiness associated with narcolepsy and obstructive sleep apnea mentions adverse events of headache, nausea, anorexia, dry mouth, anxiety, and insomnia but does not discuss ALT elevations of hepatotoxicity).
• Malhotra A, Shapiro C, Pepin JL, Hedner J, Ahmed M, Foldvary-Schaefer N, Strollo PJ, 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:zsz220. [PMC free article: PMC7315408] [PubMed: 31691827]

  (1 year extension study of solriamfetol in 643 patients who completed participation in 12-week placebo controlled trials found that the effects on excessive sleepiness were maintained, and adverse events being headache [11%], nausea [9%], insomnia [8%], dry mouth [7%], anxiety [7%], and anorexia [5%], with 9% discontinuing therapy because of adverse events; no mention of ALT elevations or hepatotoxicity).
• Thorpy MJ. Recently approved and upcoming treatments for narcolepsy. CNS Drugs. 2020;34:9–27. [PMC free article: PMC6982634] [PubMed: 31953791]

  (Review of the mechanism of action, pharmacology, drug-drug interactions, clinical efficacy and safety of newly approved medications for narcolepsy including pitolisant and solriamfetol; no mention of ALT elevations or hepatotoxicity).
• Videnovic A, Amara AW, Comella C, Schweitzer PK, Emsellem H, Liu K, Sterkel AL, et al. Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. Mov Disord. 2021 Jun 30; Epub ahead of print. [PMC free article: PMC8596433] [PubMed: 34191352]

  (Among 66 patients with Parkinson disease and excessive daytime sleepiness treated with 4 one-week courses of solriamfetol [75, 150, or 300 mg] or placebo once daily, “there were minor or no clinically meaningful changes in…clinical laboratory findings”).