Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy

Emsellem, Hélène A.; Thorpy, Michael J.; Lammers, Gert Jan; Shapiro, Colin M.; Mayer, Geert; Plazzi, Giuseppe; Chen, Dan; Carter, Lawrence P.; Villa, Kathleen F.; Lee, Lawrence; Menno, Diane; Black, Jed; Dauvilliers, Yves

doi:10.1016/j.sleep.2019.11.1250

Cited by 182 publications

(32 citation statements)

References 35 publications

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“…The TF literature identified 4 randomized, double-blind placebo-controlled trials of solriamfetol conducted with patients with unspecified narcolepsy. [90][91][92][93] Endpoints for all RCTs were excessive daytime sleepiness as measured by the ESS and MWT and disease severity using the clinical global impression scores of change (CGI-C). One study included 18 patients with NT1 and 15 patients with NT2 and used a crossover design of solriamfetol 300 mg goal dose vs placebo with endpoints measured 2 weeks after treatment initiation.…”

Section: Solriamfetolmentioning

confidence: 99%

“…93 One study was a randomized, double-blind, placebo-controlled, multicenter, 4-arm parallel-group study, wherein quality-of-life endpoints were assessed at 12 weeks. 90 Notably, the pooled analyses were conducted using data on 75 mg, 150 mg, and 300 mg doses, but the FDA has only approved the use of solriamfetol at 75 mg and 150 mg for patients with narcolepsy. 94 The meta-analyses and figures and tables are in Figures S24-S27 and Tables S49-S51 in the supplemental material.…”

Section: Solriamfetolmentioning

confidence: 99%

“…Quality of life: One RCT 90 evaluated the effect of solriamfetol on quality of life in patients with unspecified narcolepsy utilizing the FOSQ (short version) score. The mean change from baseline in patients on solriamfetol was 1.1 points higher (95% CI, 0.2-2.0 points higher) compared to placebo, which was clinically significant.…”

Section: Critical Outcomesmentioning

confidence: 99%

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Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment

Maski

Trotti

Kotagal

et al. 2021

Journal of Clinical Sleep Medicine

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Introduction: This systematic review provides supporting evidence for the accompanying clinical practice guideline on the treatment of central disorders of hypersomnolence in adults and children. The review focuses on prescription medications with U.S. Food & Drug Administration approval and nonpharmacologic interventions studied for the treatment of symptoms caused by central disorders of hypersomnolence. Methods: The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine to perform a systematic review. Randomized controlled trials and observational studies addressing pharmacological and nonpharmacological interventions for central disorders of hypersomnolence were identified. Statistical analyses were performed to determine the clinical significance of all outcomes. Finally, the Grading of Recommendations Assessment, Development and Evaluation (GRADE) process was used to assess the evidence for the purpose of making specific treatment recommendations. Results: The literature search identified 678 studies; 144 met the inclusion criteria and 108 provided data suitable for statistical analyses. Evidence for the following interventions is presented: armodafinil, clarithromycin, clomipramine, dextroamphetamine, flumazenil, intravenous immune globulin (IVIG), light therapy, lithium, L-carnitine, liraglutide, methylphenidate, methylprednisolone, modafinil, naps, pitolisant, selegiline, sodium oxybate, solriamfetol, and triazolam. The task force provided a detailed summary of the evidence along with the quality of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations.

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Section: Solriamfetolmentioning

confidence: 99%

Section: Solriamfetolmentioning

confidence: 99%

See 1 more Smart Citation

Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment

Maski

Trotti

Kotagal

et al. 2021

Journal of Clinical Sleep Medicine

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“…23 In narcolepsy patients, solriamfetol at doses of 150 mg and 300 mg also improved measures of functional status, health-related QOL, work productivity, and reduced activity impairment compared to placebo. 45…”

Section: Tones 2 (Narcolepsy)mentioning

confidence: 99%

Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives

Abad¹

2021

NSS

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Excessive sleepiness (ES) is a symptom of obstructive sleep apnea (OSA) and narcolepsy that has severe consequences. Wake-promoting drugs and stimulants are utilized as accessory treatment in OSA to reduce propensity to sleep but they do not improve sleepdisordered breathing. Solriamfetol is a first-line therapeutic agent to combat sleepiness in OSA and narcolepsy patients that is approved both by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For excessively sleepy adult patients with OSA despite primary treatment or narcolepsy patients without cataplexy, solriamfetol may be used as initial therapy or as replacement therapy in patients who fail treatment or experience unacceptable side effects with modafinil, armodafinil, pitolisant, or stimulants. It can also be used as add-on therapy in OSA or narcolepsy patients when ES is only partially controlled with modafinil, armodafinil, pitolisant, sodium oxybate, or stimulants. Solriamfetol is a phenylalanine derivative whose wake-promoting action may be mediated through its selective dopamine and norepinephrine reuptake inhibition. This paper reviews the profile of solriamfetol in treating ES associated with OSA or narcolepsy and discusses patient selection and clinical perspectives. Mechanism of action, pharmacology, pharmacokinetics, clinical efficacy, and tolerability of solriamfetol are described. The Treatment of OSA and Narcolepsy Excessive Sleepiness (TONES) solriamfetol trials demonstrated the efficacy of solriamfetol in reducing propensity to sleep and maintaining wakefulness, with significant improvements in mean maintenance of wakefulness test (MWT) sleep latencies and significant reduction in Epworth Sleepiness Scale (ESS) scores compared to placebo. With solriamfetol, significantly higher percentages of patients showed improvement in patient's and clinician's global impression of change.

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“…10 Subjective assessments of functionality, work productivity, and quality of life have shown positive improvements with solriamfetol doses of 150 or 300 mg daily. 11 Although the FDA has approved lower doses of 3.75 mg daily and 75 mg daily, the true effect for these are unknown, based on the literature.…”

Section: Relevance To Patient Care and Practicementioning

confidence: 99%

Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea

2020

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Objective: The purpose of this article is to review the available clinical trial data that led to the Food and Drug Administration (FDA) approval of solriamfetol as well as its role in clinical practice. Data Sources: A MEDLINE/PubMed search was conducted (January 2000 to February 2020) using the keyword solriamfetol to discover appropriate clinical trials. Study Selection and Data Extraction: Articles were included that were published in the English language and related to the FDA approval of solriamfetol or provided novel information regarding this drug entity. Data Synthesis: The findings of the review show that solriamfetol may be a safe and effective option for the treatment of excessive sleepiness (ES) related to narcolepsy and obstructive sleep apnea (OSA). Relevance to Patient Care and Clinical Practice: Solriamfetol is distinguished from other stimulants in that it has lower binding affinity to dopamine and norepinephrine transporters and does not have the monoamine-releasing effects of amphetamines at usual therapeutic doses. Because of solriamfetol’s unique mechanism of action, there may be a reduction in abuse potential compared with the other currently FDA-approved options. Conclusions: In clinical trials, solriamfetol has shown dose-dependent improvement in wakefulness over placebo and adds another option for clinicians when treating ES in narcolepsy and OSA.

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Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy

Cited by 182 publications

References 35 publications

Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment

Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment

Profile of Solriamfetol in the Management of Excessive Daytime Sleepiness Associated with Narcolepsy or Obstructive Sleep Apnea: Focus on Patient Selection and Perspectives

Solriamfetol for Excessive Sleepiness in Narcolepsy and Obstructive Sleep Apnea

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