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- || Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment closed: SHARP: Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study (clinicaltrials.gov) - Apr 8, 2022
P4, N=164, Active, not recruiting, Sponsor: Jazz Pharmaceuticals
Recruiting --> Active, not recruiting
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal: A Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Study of the Effects of Solriamfetol on QTcF Intervals in Healthy Participants. (Pubmed Central) - Mar 25, 2022
Common AEs were nausea, dizziness, and palpitations. Neither solriamfetol dose resulted in QTcF prolongation > 10 milliseconds.
- | Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment open, Trial initiation date: A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults (clinicaltrials.gov) - Mar 14, 2022
P2/3, N=60, Recruiting, Sponsor: Massachusetts General Hospital
Neither solriamfetol dose resulted in QTcF prolongation > 10 milliseconds. Not yet recruiting --> Recruiting | Initiation date: May 2021 --> Aug 2021
- | Sunosi (solriamfetol) / Jazz
@JazzPharma - Your product, Sunosi, is mentioned during this podcast. (Twitter) - Feb 27, 2022
- || Wakix (pitolisant) / Ferrer International, Paragon Biosci, Sunosi (solriamfetol) / Jazz
Clinical, Journal: Pharmacotherapy of residual excessive sleepiness among continuous positive airway pressure (CPAP) treated patients with sleep apnea. (Pubmed Central) - Feb 26, 2022
The distinctive pharmacologic profile and mode of action of each of these agents offer the opportunity of a personalized approach to the management of this disorder. Further studies should be conducted on the long-term effect of these agents alone or in combination on brain structural and functional changes.
- Sunosi (solriamfetol) / Jazz
Efficacy and tolerability of solriamfetol in OSA and narcoleptic patients: real-world evidence from an Italian multicenter study. (Room 11) - Feb 26, 2022 - Abstract #WSS2022WSS_1992;
The preliminary results of this real-world study showed a good efficacy and tolerability of solriamfetol in our series of patients treated for narcoleptic hypersomnia or EDS secondary to OSA. A longer follow-up is needed to confirm these results.
- Sunosi (solriamfetol) / Jazz
Residual EDS in OSA patients: The Solriamfetol proposal: With the contribution of Jazz Pharmaceuticals (Room 11) - Feb 26, 2022 - Abstract #WSS2022WSS_1800;
- Sunosi (solriamfetol) / Jazz
Trial design: Solriamfetol’s effect on cognitive Health in Apnea participants during a Randomized Placebo-controlled study (SHARP) (Concourse / Mezzanine) - Feb 26, 2022 - Abstract #WSS2022WSS_1439;
P4
A longer follow-up is needed to confirm these results. This ongoing study is the first to examine solriamfetol’s impact in participants with EDS associated with OSA on cognitive impairment, an important symptom that increases patients’ accident risk and reduces daily functioning.
- Sunosi (solriamfetol) / Jazz
Post reimbursement analysis of the impact of solriamfetol prescription on CPAP adherence (SOPRANO): Design of a nationwide retrospective analysis in real-world CPAP-treated French patients with OSA (Concourse / Mezzanine) - Feb 26, 2022 - Abstract #WSS2022WSS_911;
This ongoing study is the first to examine solriamfetol’s impact in participants with EDS associated with OSA on cognitive impairment, an important symptom that increases patients’ accident risk and reduces daily functioning. The results of the SOPRANO study will help determine whether solriamfetol treatment affects CPAP adherence in a real-world OSA population.
- Sunosi (solriamfetol) / Jazz
Solriamfetol Real World Experience Study (SURWEY): Initiation and Titration Strategies Among Physicians Prescribing Solriamfetol for Patients with Narcolepsy from Germany (Concourse / Mezzanine) - Feb 26, 2022 - Abstract #WSS2022WSS_851;
This study provides the first multicentre real-world data describing the use of solriamfetol in a cohort of patients with narcolepsy in Germany. Most patients in this study were switched from a prior medication to solriamfetol, with lack of efficacy cited as the most common reason for switching. Solriamfetol was typically initiated at 75 mg/day; titration after initiation was common.
- Wakix (pitolisant) / Ferrer International, Paragon Biosci, Sunosi (solriamfetol) / Jazz
Patient and healthcare provider surveys of narcolepsy disease burden and oxybate treatment experience (Concourse / Mezzanine) - Feb 26, 2022 - Abstract #WSS2022WSS_845;
While both individuals with narcolepsy and HCPs had moderate-to-high satisfaction with current narcolepsy treatment options, unmet needs remain regarding aspects of treatment such as dosing frequency. If approved, ON-SXB may address a significant unmet need in eliminating the middle-of-the-night dose.
- Sunosi (solriamfetol) / Jazz
Solriamfetol Real World Experience Study (SURWEY): Safety, Effectiveness, and Experience During Follow-Up for Patients with Narcolepsy from Germany (Concourse / Mezzanine) - Feb 26, 2022 - Abstract #WSS2022WSS_88;
ESS scores improved after solriamfetol initiation across all subgroups (changeover, add on, and new-to-therapy), and over 90% of patients and physicians perceived improvement in EDS. Common adverse events were consistent with those reported for solriamfetol in the clinical trial setting.
- ||| Sunosi (solriamfetol) / Jazz
Clinical, Journal, Adverse events: Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. (Pubmed Central) - Feb 19, 2022
P3
Common adverse events were consistent with those reported for solriamfetol in the clinical trial setting. Common early-onset TEAEs with solriamfetol are limited in duration, with the majority subsiding during the first week of treatment.
- Sunosi (solriamfetol) / Axsome Therap
Solriamfetol Improves Chronic Sleep Fragmentation-Induced Adverse Effects on Novel Object Recognition in Mice (Room 2022/2024 (West Building, Level 2), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_2122;
SF induces cognitive NOR impairments in mice along with reduced anxiety behaviors. SOL, but not MOD, significantly improves SF-induced NOR deficits, but has no effects on EPMT performance.
- Sunosi (solriamfetol) / Axsome Therap
Solriamfetol and Modafinil Ameliorate Excessive Sleepiness in Mice Exposed to Chronic Intermittent Hypoxia (Room 2022/2024 (West Building, Level 2), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_2121;
SOL, but not MOD, significantly improves SF-induced NOR deficits, but has no effects on EPMT performance. Chronic IH mimicking OSA induces EDS in young adult mice that is ameliorated by SOL and MOD, with SOL exhibiting equivalent efficacy to MOD as a wake-promoting agent
- Sunosi (solriamfetol) / Axsome Therap
Cognitive Deficits in Mice Exposed to Chronic Intermittent Hypoxia: Effect of Solriamfetol (Room 2022/2024 (West Building, Level 2), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_2120;
Pharmacologic treatments in RA-exposed mice did not modify behavioral performance. However, SOL, but not MOD, markedly improved NOR performance with modest effects on anxiety.
- Sunosi (solriamfetol) / Axsome Therap
Solriamfetol and Modafinil Mitigate Chronic Sleep Fragmentation-Induced Increases in Sleep Propensity (Room 2022/2024 (West Building, Level 2), Moscone Center) - Feb 19, 2022 - Abstract #ATS2022ATS_2119;
However, SOL, but not MOD, markedly improved NOR performance with modest effects on anxiety. Chronic SF, a major hallmark of OSA, induces EDS in young adult mice that is mitigated by SOL and MOD, with SOL displaying comparable efficacy to MOD as a wake-promoting agent
- | Wakix (pitolisant) / Ferrer International, Paragon Biosci, Sunosi (solriamfetol) / Jazz
Preclinical, Journal: Pitolisant, a wake-promoting agent devoid of psychostimulant properties: Preclinical comparison with amphetamine, modafinil, and solriamfetol. (Pubmed Central) - Feb 15, 2022
Therefore, pitolisant presents biochemical, neurochemical, and behavioral profiles different from those of amphetamine and other psychostimulants such as modafinil or solriamfetol. In conclusion, pitolisant is a differentiated therapeutic option, when compared with psychostimulants, for the treatment of EDS, as this agent does not show any amphetamine-like properties within in vivo preclinical models.
- | Sunosi (solriamfetol) / Jazz
Journal: Enantioseparation of solriamfetol and its major impurity phenylalaninol by capillary electrophoresis using sulfated gamma cyclodextrin. (Pubmed Central) - Feb 10, 2022
The optimized method (45 mM Tris-acetate buffer, pH = 4.5, 4 mM S-?-CD, 21°C, + 19.5 kV) was capable for the baseline separation of solriamfetol and phenylalaninol enantiomers within 7 min. The optimized method was validated according to the ICH guidelines and successfully applied for the analysis of pharmaceutical preparation (Sunosi 75 mg tablet), thus it may serve as a routine procedure for the laboratories of regulatory authorities as well as in Pharmacopoeias.
- | Xywav (calcium/magnesium/potassium/sodium oxybates) / Jazz
Journal: Xywav - a mixed-salt oxybate oral solution for idiopathic hypersomnia. (Pubmed Central) - Feb 8, 2022
The optimized method was validated according to the ICH guidelines and successfully applied for the analysis of pharmaceutical preparation (Sunosi 75 mg tablet), thus it may serve as a routine procedure for the laboratories of regulatory authorities as well as in Pharmacopoeias. No abstract available
- ||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment open: Solriamfetol in Binge Eating Disorder (clinicaltrials.gov) - Feb 2, 2022
P4, N=64, Recruiting, Sponsor: Lindner Center of HOPE
No abstract available Not yet recruiting --> Recruiting
- | Sunosi (solriamfetol) / Jazz
Journal: Indirect treatment comparison of solriamfetol, modafinil, and armodafinil for excessive daytime sleepiness in obstructive sleep apnea. (Pubmed Central) - Dec 25, 2021
Not yet recruiting --> Recruiting The results of this ITC show 12 weeks of treatment with solriamfetol, modafinil, and armodafinil resulted in varying levels of improvement on the ESS, MWT20, and CGI-C and similar safety risks in participants with EDS associated with OSA.
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal: Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea. (Pubmed Central) - Dec 23, 2021
P3
Minimally important difference and clinically important response estimates for the FOSQ-10 for adults with excessive daytime sleepiness in narcolepsy or obstructive sleep apnea will be helpful for interpreting changes over time and defining a clinical responder. CLINICALTRIALS.
- || clarithromycin / Generic mfg.
Review, Journal: Idiopathic Hypersomnia and Other Hypersomnia Syndromes. (Pubmed Central) - Dec 16, 2021
The level of evidence for the treatment of sleepiness in these disorders is generally lower than in the well-characterized syndrome of narcolepsy, but available clinical and randomized, controlled trial data can provide guidance for the management of each of these disorders. Treatments vary by diagnosis but may include modafinil/armodafinil, traditional psychostimulants, solriamfetol, pitolisant, clarithromycin, flumazenil, sodium oxybate, melatonin, methylprednisolone, and lithium.
- || methylphenidate tablet / Generic mfg., amphetamine / Generic mfg.
Clinical, Review, Journal: European guideline and expert statements on the management of narcolepsy in adults and children. (Pubmed Central) - Dec 16, 2021
Treatments vary by diagnosis but may include modafinil/armodafinil, traditional psychostimulants, solriamfetol, pitolisant, clarithromycin, flumazenil, sodium oxybate, melatonin, methylprednisolone, and lithium. The management of narcolepsy involves non-pharmacological and pharmacological approaches with an increasing number of symptomatic treatment options for adults and children that have been studied in some detail.
- ||| methylphenidate tablet / Generic mfg., dextroamphetamine immediate release / Generic mfg., clarithromycin / Generic mfg.
Clinical, Clinical guideline, Journal: Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine clinical practice guideline. (Pubmed Central) - Dec 16, 2021
The section on adult patients with hypersomnia because of medical conditions is categorized based on the clinical and pathological subtypes identified in ICSD-3. The interventions in all the recommendation statements were compared to no treatment.
- || Retrospective data, Review, Journal: Treatment of central disorders of hypersomnolence: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment. (Pubmed Central) - Dec 16, 2021
J Clin Sleep Med. 2021;17(9):1895-1945.
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal: Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in Obstructive Sleep Apnea: An Analysis of Subgroups Adherent or Nonadherent to Obstructive Sleep Apnea Treatment. (Pubmed Central) - Nov 29, 2021
P=N/A, P3
Solriamfetol improved EDS in OSA regardless of primary OSA therapy adherence. Primary OSA therapy use was unaffected with solriamfetol.
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal: Study protocol and rationale for a randomized, placebo-controlled trial of solriamfetol to treat binge eating disorder. (Pubmed Central) - Nov 29, 2021
P4
To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of solriamfetol in BED. We highlight the background and rationale for this study, including a discussion on using DNRIs in BED.
- | Sunosi (solriamfetol) / Jazz
Journal, HEOR: Long-term effects of solriamfetol on quality of life and work productivity in participants with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea. (Pubmed Central) - Oct 28, 2021
P3
Long-term solriamfetol treatment was associated with clinically meaningful, sustained improvements in functional status, work productivity, and quality of life for up to 52 weeks. Adverse events were similar between narcolepsy and OSA.
- || Sunosi (solriamfetol) / Jazz
P2 data, Journal: Solriamfetol for Excessive Daytime Sleepiness in Parkinson's Disease: Phase 2 Proof-of-Concept Trial. (Pubmed Central) - Oct 27, 2021
Safety/tolerability was consistent with solriamfetol's known profile. There were no significant improvements on ESS; MWT results suggest possible benefit with solriamfetol in PD.
- || methylphenidate tablet / Generic mfg., amphetamine / Generic mfg.
Clinical, Journal: European guideline and expert statements on the management of narcolepsy in adults and children. (Pubmed Central) - Oct 22, 2021
There were no significant improvements on ESS; MWT results suggest possible benefit with solriamfetol in PD. The management of narcolepsy involves non-pharmacological and pharmacological approaches with an increasing number of symptomatic treatment options for adults and children that have been studied in some detail.
- Sunosi (solriamfetol) / Jazz
[VIRTUAL] SOLRIAMFETOL TITRATION AND ADMINISTRATION: PHYSICIAN TITRATION STRATEGIES IN A HYPOTHETICAL PATIENT WITH OSA () - Oct 13, 2021 - Abstract #CHEST2021CHEST_2411;
Most physicians considered specific factors when titrating (most commonly the dose of prior medication). Most would not change their approach due to controlled hypertension.
- Sunosi (solriamfetol) / Jazz
[VIRTUAL] SOLRIAMFETOL TITRATION AND ADMINISTRATION: DOSING AND TITRATION STRATEGIES IN PATIENTS WITH OSA STARTING SOLRIAMFETOL () - Oct 13, 2021 - Abstract #CHEST2021CHEST_2410;
Physicians were overall confident in recommending their titration strategy for similar patients. CLINICAL IMPLICATIONS: These real-world data indicate that physicians prescribing solriamfetol for EDS associated with OSA often start solriamfetol at 37.5 or 75 mg/d and most patients reach stable doses of 75 or 150 mg/d.
- | Sunosi (solriamfetol) / Jazz
@JazzPharma I can't open the Sunosi bottle!! Is there a hack? (Twitter) - Oct 12, 2021
- ||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment open: Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder (clinicaltrials.gov) - Oct 6, 2021
P4, N=110, Recruiting, Sponsor: Charles Andrew Czeisler, MD, PhD
CLINICAL IMPLICATIONS: These real-world data indicate that physicians prescribing solriamfetol for EDS associated with OSA often start solriamfetol at 37.5 or 75 mg/d and most patients reach stable doses of 75 or 150 mg/d. Not yet recruiting --> Recruiting
- Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment open: Evaluate Sunosi (clinicaltrials.gov) - Oct 3, 2021
P4, N=10, Recruiting, Sponsor: Jazz Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || methylphenidate tablet / Generic mfg.
Clinical, Review, Journal: Drugs for patients with epilepsy and excessive daytime sleepiness. (Pubmed Central) - Sep 18, 2021
Several meta-analyses suggested that lamotrigine, lacosamide, and perhaps eslicarbazepine are less sedative than other traditional and new ASMs and, in patients prone to somnolence, might be preferred over ASMs with more sedative properties...Methylphenidate, modafinil, armodafinil, pitolisant, and solriamfetol are authorized for use in ADHD and EDS in patients with narcolepsy and some of them also in OSAS...The risks of cardiovascular events and psychiatric symptoms should be carefully evaluated as such disorders can coexist with epilepsy and be triggered by these agents. Finally, combination of psychostimulants with ASMs may be associated with several pharmacokinetic drug-drug interactions.
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal: Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. (Pubmed Central) - Aug 20, 2021
P3
These data strongly indicate that solriamfetol was effective in treating EDS in participants with narcolepsy with or without cataplexy, as indicated by robust effects on MWT, ESS, and PGI-C. The safety profile was similar regardless of cataplexy status.
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal: Excessive Daytime Sleepiness in Obstructive Sleep Apnea: Mechanisms and Clinical Management. (Pubmed Central) - Aug 20, 2021
Agents that inhibit reuptake of dopamine or of dopamine and norepinephrine (modafinil/armodafinil and solriamfetol, respectively) have demonstrated efficacy in reducing EDS and improving quality of life in patients with OSA. Additional research is needed on the effects of wake-promoting treatments on cognition in these patients and to identify individual or disorder-specific responses.
- Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
New P4 trial: Evaluate Sunosi (clinicaltrials.gov) - Aug 16, 2021
P4, N=10, Not yet recruiting, Sponsor: Jazz Pharmaceuticals
- || Sunosi (solriamfetol) / Jazz
Clinical, Journal, HEOR: Relationship between sleep efficacy endpoints and measures of functional status and health-related quality of life in participants with narcolepsy or obstructive sleep apnea treated for excessive daytime sleepiness. (Pubmed Central) - Jul 15, 2021
Data from two 12-week randomized controlled trials of solriamfetol were analyzed...Other correlations were low. Self-reported assessments of sleepiness and global improvement appear to be more strongly correlated with measures of functioning and health-related quality of life than objectively assessed sleepiness.
- | Sunosi (solriamfetol) / Jazz
Journal: Effects of solriamfetol in a long-term trial of participants with obstructive sleep apnea who are adherent or nonadherent to airway therapy. (Pubmed Central) - Jul 1, 2021
P3
Long-term efficacy and safety of solriamfetol were similar regardless of adherence to primary OSA therapy. Solriamfetol did not affect primary therapy use.
- || Sunosi (solriamfetol) / Jazz
Clinical, Retrospective data, Journal: Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a post hoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. (Pubmed Central) - Jul 1, 2021
P=N/A, P3
A greater percentage of solriamfetol-treated participants achieved normal ESS scores (≤10) or clinically meaningful improvements on the ESS compared with those receiving placebo. Safety profile was similar between narcolepsy and OSA.
- ||| Sunosi (solriamfetol) / Jazz
Clinical, P3 data, Journal, HEOR: Effects of Solriamfetol on Quality of Life Measures From a 12-Week Phase 3 Randomized Trial. (Pubmed Central) - Jun 24, 2021
P3
Safety was consistent with previous studies. Clinical trial registered with ClinicalTrials.gov (NCT02348606).
- || methylphenidate tablet / Generic mfg.
Clinical, Review, Journal: Update on the pharmacologic management of narcolepsy: mechanisms of action and clinical implications. (Pubmed Central) - Jun 22, 2021
Medications approved by the US Food and Drug Administration (FDA) for the treatment of EDS in narcolepsy include traditional stimulants (eg, amphetamines, methylphenidate), wake-promoting agents (eg, modafinil, armodafinil), and solriamfetol, which mainly act on dopaminergic and noradrenergic pathways...Pitolisant, a histamine 3 (H)-receptor antagonist/inverse agonist, is approved by the European Medicines Agency (EMA) for the treatment of narcolepsy with or without cataplexy in adults and by the FDA for the treatment of EDS in adults with narcolepsy...In many patients with narcolepsy, combination treatment with medications that act via different neural pathways is necessary for optimal symptom management. Mechanism of action, pharmacokinetics, and abuse potential are important considerations in treatment selection and subsequent medication adjustments to maximize efficacy and mitigate adverse effects in the treatment of patients with narcolepsy.
- || Sunosi (solriamfetol) / Jazz
Retrospective data, Review, Journal: Efficacy and safety of solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea: a systematic review and meta-analysis of clinical trials. (Pubmed Central) - Jun 22, 2021
Solriamfetol is efficacious and has a favorable safety profile in the treatment of EDS in patients with narcolepsy and OSA. Solriamfetol is well tolerated and may be recommended for the treatment of EDS in these patients.
- || Sunosi (solriamfetol) / Jazz
Clinical, Review, Journal: Efficacy and safety of solriamfetol for excessive sleepiness in narcolepsy and obstructive sleep apnea: findings from randomized controlled trials. (Pubmed Central) - Jun 22, 2021
A dose of 150 mg solriamfetol is proved to be the appropriate and stable dose for excessive sleepiness. In addition, solriamfetol showed good efficacy for excessive sleepiness in narcolepsy and OSA but also significantly increases the risk of adverse events.
- || Review, Journal: Recently Approved and Upcoming Treatments for Narcolepsy. (Pubmed Central) - Jun 10, 2021
Several new agents are being developed and tested as potential treatments for EDS and cataplexy associated with narcolepsy; these agents include novel oxybate formulations (once-nightly [FT218]; low sodium [JZP-258]), a selective norepinephrine reuptake inhibitor (AXS-12), and a product combining modafinil and an astroglial connexin inhibitor (THN102). This review summarises the mechanisms of action, pharmacokinetics, efficacy, and safety/tolerability of recently approved and emerging treatments for narcolepsy.
- Sunosi (solriamfetol) / Jazz
[VIRTUAL] Solriamfetol in the treatment of narcolepsy: real-world experience from the first 100 patients (Main Auditorium) - May 30, 2021 - Abstract #EAN2021EAN_1786;
These first real-world results on solriamfetol showed a good effect on EDS. The drug was mostly well tolerated with headaches (29.5%) being the most frequent occurrence.