- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion date, Trial termination: Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder (clinicaltrials.gov) - Apr 7, 2025
P4, N=82, Terminated,
All four WPAs were associated with a low risk of serious or adverse events. Trial completion date: Nov 2024 --> Apr 2024 | Recruiting --> Terminated; Study was stopped due to funding limitations.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion, Trial completion date, Trial primary completion date: A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (clinicaltrials.gov) - Apr 7, 2025
P4, N=44, Completed,
Trial completion date: Nov 2024 --> Apr 2024 | Recruiting --> Terminated; Study was stopped due to funding limitations. Active, not recruiting --> Completed | Trial completion date: May 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Sep 2024
- |||||||||| Wakix (pitolisant) / Ferrer International, Paragon Biosci, Aculys Pharma, Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Review, Journal: Management options for excessive daytime sleepiness in patients with obstructive sleep apnea. (Pubmed Central) - Apr 1, 2025
Solriamfetol and pitolisant are wake-promoting agents (WPA) recently approved for use in sleepy OSA patients accepting or refusing OSA treatment...However, it is still uncertain which subgroups of patients should be treated for the symptom of EDS while maintaining a low-risk profile in terms of consequences of OSA on health. Until such data are available, use of WPA in OSA patients should be managed by Sleep Specialists.
- |||||||||| Wakix (pitolisant) / Ferrer International, Paragon Biosci, Aculys Pharma, Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Journal: Expert consensus on the diagnosis and treatment of excessive daytime sleepiness in obstructive sleep apnea (Pubmed Central) - Mar 31, 2025
Regular encouragement to continue conventional OSA therapy should be provided throughout the treatment period.Recommendation 10: Methylphenidate or dextroamphetamine is not currently recommended for OSA-related EDS due to insufficient evidence (no evidence, D).Recommendation 11: Regular monitoring of the efficacy and safety of wake-promoting agents is recommended...Strict monitoring for adverse effects is required during treatment, including the risk of drug dependence, addiction, and cardiovascular events. Caution should be exercised when prescribing these agents to patients with cardiovascular risk factors (3, B).
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Clinical, P4 data, Journal: Results of the SHARP Study: A Randomized, Placebo-Controlled, Double-Blind, Repeated-Measures, Crossover, Phase IV Clinical Trial of the Effect of the Wake-Promoting Agent Solriamfetol on Cognitive Function in Obstructive Sleep Apnea With Excessive Daytime Sleepiness and Cognitive Impairment. (Pubmed Central) - Mar 12, 2025
P4
Caution should be exercised when prescribing these agents to patients with cardiovascular risk factors (3, B). SHARP showed that solriamfetol can improve objective and subjective measures of cognitive function in patients with cognitive impairment associated with OSA and EDS.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Retrospective data, Journal: Patients with obstructive sleep apnea in Germany. (Pubmed Central) - Feb 27, 2025
Most patients in this study were new to therapy. Solriamfetol was typically initiated at 37.5
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment change, Trial termination, HEOR: Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (clinicaltrials.gov) - Dec 26, 2024
P2, N=2, Terminated,
Solriamfetol was typically initiated at 37.5 N=36 --> 2 | Suspended --> Terminated; Axsome has conducted a review of the ongoing IST program and are unable to continue supporting this study
- |||||||||| Wakix (pitolisant) / Ferrer International, Paragon Biosci, Aculys Pharma, Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Retrospective data, Journal: Evaluation of pitolisant, sodium oxybate, solriamfetol, and modafinil for the management of narcolepsy: a retrospective analysis of the FAERS database. (Pubmed Central) - Nov 26, 2024
However, potential novel or notable ADE signals were identified through real-world pharmacovigilance analysis. It is anticipated that this paper will offer additional information regarding safe and rational medication for narcolepsy.
- |||||||||| Wakix (pitolisant) / Ferrer International, Paragon Biosci, Aculys Pharma, Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Review, Journal: Comorbidity of obstructive sleep apnea and narcolepsy: A challenging diagnosis and complex management. (Pubmed Central) - Oct 10, 2024
The association with OSA is likely to be explained by the involvement of orexin in hypercapnic-hypoxic responses: a deficit of orexin may promote obstructive events during sleep. Open questions warrant further investigation, especially orexin's involvement in other sleep disorders associated with EDS, and the more appropriate treatment for the OSA-narcolepsy comorbidity.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion date, Trial primary completion date: Solriamfetol and CBT-I in Patients With Insomnia Disorder (clinicaltrials.gov) - Sep 19, 2024
P4, N=60, Recruiting,
Bioprojet. Trial completion date: Feb 2025 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Jul 2025
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment open: RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia) (clinicaltrials.gov) - Jun 28, 2024
P2, N=474, Recruiting,
Treatment decisions should involve a personalized assessment of patient factors and desired outcomes. Not yet recruiting --> Recruiting
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment open: RECOVER-SLEEP: Platform Protocol (clinicaltrials.gov) - Jun 27, 2024
P2, N=1074, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- |||||||||| Qelbree (viloxazine) / Supernus Pharma, Knight Therap
Review, Journal: Recent advances in pharmacological management of attention-deficit/hyperactivity disorder: moving beyond stimulants. (Pubmed Central) - Jun 18, 2024
Two others, clonidine ER and guanfacine ER, are only approved for children and adolescents in the US...Drugs in Phase 3 trials include centanafadine, solriamfetol, and L-threonic acid magnesium salt...Lack of individual drug response and tolerability are reasons many stop treatment. Development of new nonstimulants may offer hope for patients who need medication alternatives.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion date, Trial primary completion date, HEOR: Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (clinicaltrials.gov) - Jun 11, 2024
P2, N=36, Suspended,
Development of new nonstimulants may offer hope for patients who need medication alternatives. Trial completion date: Jul 2024 --> Jul 2025 | Trial primary completion date: Jul 2024 --> Jul 2025
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Preclinical, Review, Journal: Hits and misses with animal models of narcolepsy and the implications for drug discovery. (Pubmed Central) - May 15, 2024
Advancements in pharmacological therapies have significantly improved narcolepsy management, with insights from both clinical experience and from animal models having led to new treatments such as low sodium oxybate and solriamfetol. However, challenges persist in addressing symptoms beyond excessive daytime sleepiness and cataplexy, highlighting the need for further research, including the development of diurnal animal models to enhance understanding and treatment options for narcolepsy.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
New trial: SUNOSI (clinicaltrials.gov) - May 14, 2024
P=N/A, N=1731, Recruiting,
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
New P2 trial: RECOVER-SLEEP: Platform Protocol (clinicaltrials.gov) - May 8, 2024
P2, N=1074, Not yet recruiting,
- |||||||||| FDA event, Review, Journal: A Comprehensive Review of Novel FDA-Approved Psychiatric Medications (2018-2022). (Pubmed Central) - Apr 22, 2024
To examine whether solriamfetol improve memory in mice that were exposed to long-term intermittent hypoxia (IH) or sleep fragmentation (SF) protocols that induce declarative memory deficits. We found 12 novel psychiatric medications approved by the FDA from 2018 to 2022, representing a very small percentage of the total FDA approvals during that
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion date, Trial primary completion date, HEOR: Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (clinicaltrials.gov) - Apr 10, 2024
P2, N=36, Suspended,
We found 12 novel psychiatric medications approved by the FDA from 2018 to 2022, representing a very small percentage of the total FDA approvals during that Trial completion date: Mar 2024 --> Jul 2024 | Trial primary completion date: Mar 2024 --> Jul 2024
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial initiation date: SOLARIMS: Solriamfetol for the Treatment of Multiple Sclerosis Fatigue (clinicaltrials.gov) - Mar 13, 2024
P2, N=46, Not yet recruiting,
Trial completion date: Mar 2024 --> Jul 2024 | Trial primary completion date: Mar 2024 --> Jul 2024 Initiation date: Mar 2024 --> Jun 2024
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Review, Journal: A Comprehensive Review of Solriamfetol to Treat Excessive Daytime Sleepiness. (Pubmed Central) - Mar 11, 2024
There is no cure to daytime somnolence and current pharmacotherapeutic regimens have worrisome side effect profiles. Solriamfetol is a new class of drug that offers a safe and effective alternative option for clinical providers treating excessive daytime sleepiness.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Journal: Solriamfetol and m-Chlorophenylpiperazine Cause False Positive Amphetamine Results on Urine Drug Screening. (Pubmed Central) - Mar 4, 2024
We demonstrate the Thermo Scientific DRI assay is susceptible to interferences from mCPP, the main metabolite of trazodone, and solriamfetol. Characterization of assay specific interferences in toxicology screening is instrumental for accurate interpretation of toxicology results, evaluation of patients in emergent settings, and supporting patient care.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion date, Trial primary completion date: Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder (clinicaltrials.gov) - Feb 15, 2024
P4, N=110, Recruiting,
Characterization of assay specific interferences in toxicology screening is instrumental for accurate interpretation of toxicology results, evaluation of patients in emergent settings, and supporting patient care. Trial completion date: Mar 2024 --> Nov 2024 | Trial primary completion date: Dec 2023 --> Apr 2024
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Enrollment closed, Trial completion date, Trial primary completion date: A Trial of Solriamfetol in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (clinicaltrials.gov) - Jan 31, 2024
P4, N=44, Active, not recruiting,
However, further experimental studies are required to confirm their antibacterial potential. Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> May 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Trial completion date, Trial primary completion date, HEOR: Solriamfetol in Improving Sleep in Patients With Grade II-IV Glioma (clinicaltrials.gov) - Dec 20, 2023
P2, N=36, Suspended,
Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> May 2024 | Trial primary completion date: Dec 2023 --> Mar 2024 Trial completion date: Dec 2023 --> Mar 2024 | Trial primary completion date: Nov 2023 --> Mar 2024
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Review, Journal: Solriamfetol: A Review in Excessive Daytime Sleepiness Associated with Narcolepsy and Obstructive Sleep Apnoea. (Pubmed Central) - Nov 24, 2023
Solriamfetol demonstrated a consistent safety and tolerability profile across clinical studies, with commonly reported adverse reactions generally occurring within 2 weeks of treatment initiation and mostly resolving within 2 weeks. Thus, solriamfetol represents a useful treatment option for adults with EDS associated with narcolepsy or OSA.
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
New P3 trial: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients With Obstructive Sleep Apnea (OSA) (clinicaltrials.gov) - Oct 27, 2023
P3, N=204, Recruiting,
- |||||||||| Sunosi (solriamfetol) / Axsome Therap, Pharmanovia
Solriamfetol for ADHD in Adults: A Double-Blind Placebo-Controlled Pilot Study (Americas Hall II (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_587;
There was no significant association between solriamfetol and change in PSQI scale scores. Conclusions Our pilot study suggests that solriamfetol is an effective and safe treatment for adults with ADHD, and replication of our findings is merited.
- |||||||||| Qelbree (viloxazine) / Supernus Pharma
What (Rhinelander South (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_108;
Others in clinical trials include: dexmethylphenidate ER (CTX 1301), a stimulant designed to last up to 16 hours; L-threonic acid magnesium salt, a compound that has been shown to improve ADHD symptoms in adults; and solriamfetol, a dopamine and norepinephrine reuptake inhibitor that is FDA-approved for patients with narcolepsy. Conclusions Participants will gain a better understanding of the efficacy and safety of newly approved FDA products, as well as investigational products, for the treatment of ADHD.
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