- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Review, Journal: What place for daridorexant? (Pubmed Central) - Nov 29, 2024
NCT05702177. No abstract available
- |||||||||| Review, Journal: Proline Analogues in Drug Design: Current Trends and Future Prospects. (Pubmed Central) - Nov 28, 2024
Additionally, we discuss several intriguing cases where nonproline residues were replaced with proline analogues as a strategy to eliminate unwanted hydrogen bond donor sites. In conclusion, we present some suggestions for the future exploration of this promising class of molecular entities in drug discovery.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Journal: Orexin Receptor Antagonists for the Prevention and Treatment of Alzheimer's Disease and Associated Sleep Disorders. (Pubmed Central) - Nov 28, 2024
Conversely, research on selective orexin receptor antagonists in AD is currently limited. Further investigation is needed to explore orexin antagonism not only as a symptomatic treatment for sleep disturbances, but also for its broader implications in modifying AD neurodegeneration, emphasizing mechanisms of action and long-term outcomes.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Enrollment open: Daridorexant to Prevent Delirium After Heart Surgery (clinicaltrials.gov) - Nov 13, 2024
P2, N=12, Enrolling by invitation,
Daridorexant reduced EEG features associated with hyperarousal as indicated by reduced wake-to-wake transition probabilities and enhanced spectral features associated with drowsiness and sleep during wake and N1. Not yet recruiting --> Enrolling by invitation
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Trial completion, Trial completion date, Trial primary completion date: A Study of Daridorexant in Chinese Patients With Insomnia Disorder (clinicaltrials.gov) - Oct 30, 2024
P3, N=206, Completed,
Not yet recruiting --> Enrolling by invitation Recruiting --> Completed | Trial completion date: Dec 2025 --> May 2024 | Trial primary completion date: Dec 2025 --> Apr 2024
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Enrollment open, Real-world evidence, Patient reported outcomes, Real-world: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada (clinicaltrials.gov) - Sep 20, 2024
P=N/A, N=100, Recruiting,
Recruiting --> Completed | Trial completion date: Dec 2025 --> May 2024 | Trial primary completion date: Dec 2025 --> Apr 2024 Not yet recruiting --> Recruiting
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Journal: Long-term safety and efficacy of daridorexant in Japanese patients with insomnia disorder. (Pubmed Central) - Sep 10, 2024
Not yet recruiting --> Recruiting Up to 52-weeks, daridorexant was well tolerated with sustained improvement in sleep onset, sleep maintenance and daytime functioning, supporting its long-term use in Japanese patients with insomnia disorder.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Clinical, P3 data, Journal: Daridorexant in Japanese patients with insomnia disorder: A phase 3, randomized, double-blind, placebo-controlled study. (Pubmed Central) - Sep 10, 2024
Up to 52-weeks, daridorexant was well tolerated with sustained improvement in sleep onset, sleep maintenance and daytime functioning, supporting its long-term use in Japanese patients with insomnia disorder. In Japanese patients with insomnia disorder, daridorexant (25 and 50
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Journal, Adverse events, Real-world evidence, Real-world: Data mining and safety analysis of dual orexin receptor antagonists (DORAs): a real-world pharmacovigilance study based on the FAERS database. (Pubmed Central) - Aug 21, 2024
Additionally, some PTs occurred that were not included in drug instructions, such as "hangover" and "hypnagogic hallucination." In this study, four algorithms (ROR, PRR, BCPNN, and MGPS) were used to mine the safety signals of DORAs. We identified some potential ADE signals that can promote the rational use of DORAs and improve their safety.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Journal, Adverse events: Clinical safety of daridorexant in insomnia treatment: Analysis of FDA adverse event reports. (Pubmed Central) - Aug 10, 2024
Although some new potential AEs have been identified, these findings need further verification in broader datasets and long-term studies due to limitations in data sources and analysis methods. Future research should comprehensively assess the safety and effectiveness of daridorexant, providing more accurate guidance for medical professionals in the treatment of insomnia.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Retrospective data, Review, Journal: Association between the use of orexin receptor antagonists and falls or fractures: A meta-analysis. (Pubmed Central) - Jul 28, 2024
Future research should comprehensively assess the safety and effectiveness of daridorexant, providing more accurate guidance for medical professionals in the treatment of insomnia. Similarly, analysis of the included case-control studies revealed no significant increase in the risk of fractures associated with the use of orexin receptor antagonists (pooled adjusted OR
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Journal: Bioactive compounds from Ocimum tenuiflorum and Poria cocos: A novel natural Compound for insomnia treatment based on A computational approach. (Pubmed Central) - May 13, 2024
Furthermore, upon evaluating both compounds' drug-likeness, pharmacokinetics, and toxicity profiles, it was discerned that they displayed considerable drug-like properties and favorable pharmacokinetics, along with diminished toxicity. The research provides a solid foundation for further exploring and validating these compounds as potential anti-insomnia therapeutics.
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
New trial, Claims database: Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant) (clinicaltrials.gov) - May 1, 2024
P=N/A, N=2095, Active, not recruiting,
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: DARIDOR-ALZ: Daridorexant to Treat Insomnia in Patients With Mild Cognitive Impairment and Mild to Moderate Alzheimer Disease (clinicaltrials.gov) - Apr 11, 2024
P4, N=62, Recruiting,
Daridorexant 50 mg did not induce CYP3A4 activity or inhibit CYP2C9 activity. Not yet recruiting --> Recruiting | Trial completion date: Jul 2026 --> Mar 2027 | Initiation date: Jul 2023 --> Mar 2024 | Trial primary completion date: Sep 2025 --> May 2026
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
Journal: Pharmacotherapies for insomnia (Pubmed Central) - Apr 2, 2024
Finally, a new class of hypnotics, "the orexin antagonists" has its first representative on the French market: daridorexant. The place of these molecules in the therapeutic strategy for chronic insomnia needs to be clarified.
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
Journal: Safety of Dual Orexin Receptor Antagonist Daridorexant: A Disproportionality Analysis of Publicly Available FAERS Data. (Pubmed Central) - Mar 28, 2024
A total of 845 dari-related reports were selected; nightmares (n = 146; dari vs. RG1: ROR = 113.74; 95%CI [95.13, 136]; dari vs. RG2: ROR = 2.35; 95 CI% [1.93, 2.85]), depression (n = 22; dari vs. RG1: 2.13; [1.39, 3.25]; dari vs. RG2: ROR = 2.31; 95 CI% [1.45, 3.67]), and hangover (n = 20; dari vs. RG1: ROR = 127.92; 95 CI% [81.98, 199.62]; and dari vs. RG2: 3.38; [2.04, 5.61]) were considered as safety signals. These data provide valuable insights into the real-world safety profile of daridorexant, supporting the existence of safety signals related to nightmares, depression, and hangovers.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
New trial, Real-world evidence, Patient reported outcomes, Real-world: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada (clinicaltrials.gov) - Mar 15, 2024
P=N/A, N=100, Not yet recruiting,
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
Enrollment closed: A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia (clinicaltrials.gov) - Feb 20, 2024
P4, N=60, Active, not recruiting,
However, these results are preliminary and further studies with different ORAs at different doses and with different samples are needed. Recruiting --> Active, not recruiting
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Review, Journal: The orexin story and orexin receptor antagonists for the treatment of insomnia. (Pubmed Central) - Nov 30, 2023
Safety studies did not show exacerbation of existing respiratory problems, but more real-world safety and pharmacovigilance experience is needed. This review provides an overview of the orexin history, the mechanism of action, the relation to insomnia, and key features of available drugs mediating orexin signalling.
- |||||||||| Belsomra (suvorexant) / Merck (MSD)
Preclinical, Journal: Failure of the dual orexin receptor antagonist suvorexant to engender drug discrimination in rats. (Pubmed Central) - Nov 20, 2023
For development of the dual orexin receptor antagonist (DORA) daridorexant, the FDA recommended conducting a rat drug discrimination paradigm against the approved, schedule IV, DORA suvorexant. Surprisingly, at suvorexant plasma levels up to three-fold the maximum concentration at the highest approved human dose, rats did not learn to discriminate the suvorexant stimulus from vehicle.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Viibryd (vilazodone) / AbbVie
Enrollment open: Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) - Nov 7, 2023
P2, N=600, Recruiting,
This study contributes to understanding the safety profile of FDA-approved DORAs for treating insomnia. Not yet recruiting --> Recruiting
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Dayvigo (lemborexant) / Eisai
Journal: Lemborexant and Daridorexant for the Treatment of Insomnia: An Indirect Comparison Using Number Needed to Treat, Number Needed to Harm, and Likelihood to Be Helped or Harmed. (Pubmed Central) - Oct 9, 2023
P3
Indirect comparisons of lemborexant with daridorexant suggest an efficacy advantage for lemborexant and a tolerability advantage for daridorexant. Clinical Trials Registration: NCT02783729, NCT02952820, NCT03545191, NCT03575104.
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Journal: Quviviq (Pubmed Central) - Aug 31, 2023
Clinical Trials Registration: NCT02783729, NCT02952820, NCT03545191, NCT03575104. No abstract available
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Review, Journal: Insomnia Management: A Review and Update. (Pubmed Central) - Aug 11, 2023
Pharmacologic agents that are approved by the US Food and Drug Administration for insomnia include benzodiazepine receptor agonists (zolpidem, eszopiclone, and zaleplon), low-dose doxepin (tricyclic antidepressant), ramelteon (melatonin receptor agonist), and dual orexin receptor agonists (DORAs, daridorexant, lemborexant, and suvorexant)...Daridorexant is the newest DORA, has an ideal half-life of 8 hours, and has demonstrated continued efficacy over a 12-month period. Selection of pharmacologic agent should be based on the patient's comorbid conditions, treatment goals and preferences, and other clinical characteristics.
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Journal: Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. (Pubmed Central) - Jul 21, 2023
P2, P3
Selection of pharmacologic agent should be based on the patient's comorbid conditions, treatment goals and preferences, and other clinical characteristics. Daridorexant reduced the number and duration of longer wake bouts throughout the night compared with placebo, corresponding with improved daytime functioning.
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
Trial completion date, Trial primary completion date: A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia (clinicaltrials.gov) - Jul 20, 2023
P4, N=50, Recruiting,
Daridorexant reduced the number and duration of longer wake bouts throughout the night compared with placebo, corresponding with improved daytime functioning. Trial completion date: Oct 2023 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024
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