Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei 
Welcome,         Profile    Billing    Logout  
  Diseases    Trials    Trials    News 


12345»
  • ||||||||||  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, Mochida, Syneos Health, Sosei, 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
    Enrollment open, Trial initiation date:  Department of Defense PTSD Adaptive Platform Trial - Intervention C - Daridorexant (clinicaltrials.gov) -  Nov 7, 2023   
    P2,  N=200, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Initiation date: Aug 2023 --> Nov 2023
  • ||||||||||  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
    Trial completion:  A Phase 1 Trial to Investigate the Biological Equivalence of 5  (clinicaltrials.gov) -  Aug 16, 2023   
    P1,  N=38, Completed, 
    Sponsored by Idorsia Pharmaceuticals Recruiting --> Completed
  • ||||||||||  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
    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
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Journal:  Daridorexant, an Orexin Receptor Antagonist for the Management of Insomnia. (Pubmed Central) -  Jul 18, 2023   
    Preliminary results from a 1-year extension study note similar incidences of mild-to-moderate side effects as noted in previous trials. Further studies are needed to establish its place in the pharmacological treatment of insomnia.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
    Enrollment open:  A Phase 1 Trial to Investigate the Biological Equivalence of 5  (clinicaltrials.gov) -  Jul 14, 2023   
    P1,  N=38, Recruiting, 
    No abstract available Not yet recruiting --> Recruiting
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Journal:  Daridorexant, a Recently Approved Dual Orexin Receptor Antagonists (DORA) in Treatment of Insomnia. (Pubmed Central) -  Jul 10, 2023   
    Beyond its effectiveness in insomnia, it has been successfully used in patients suffering from obstructive sleep apnoea, chronic obstructed airway disease (COAD), Alzheimer's disease (AD), hypertension, and cardiovascular disorders. Larger studies need to address the safety issues as well as obtain robust pharmacovigilance information to safeguard the risk-benefit aspect of this drug in insomniac adults.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
    Review:  Different doses of dual orexin receptor antagonists in primary insomnia: a Bayesian network analysis. (Pubmed Central) -  Jun 1, 2023   
    This analysis demonstrates the meaningful within-patient change for the IDSIQ total score and domain scores, that the instrument is sensitive to changes in the patient experience of insomnia, and that it can be used in clinical trials to evaluate changes in daytime functioning. Suvorexant 20
  • ||||||||||  A Comprehensive Review of Novel FDA Approved Psychiatric Indications From 2018-2022 (Hall B Foyer, Exhibition Level Moscone South) -  May 17, 2023 - Abstract #APA2023APA_968;    
    Clinical trials for each medication suggested favorable results in Phase III trials that lead to approval, along with current success in Phase IV trials as well. In 2018, Lucemyra (lofexidine) was approved for the treatment of opioid withdrawal.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Retrospective data, Journal:  Use of Daridorexant among Patients with Chronic Insomnia: A Retrospective Observational Analysis. (Pubmed Central) -  May 13, 2023   
    No significant adverse events were noted during the study duration. Keeping in mind this study's limitations, these data suggest that for insomnia patients with an incomplete response to current therapy, switching to daridorexant is safe and may be an effective alternative treatment.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
    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) -  May 12, 2023   
    P4,  N=50, Recruiting, 
    Keeping in mind this study's limitations, these data suggest that for insomnia patients with an incomplete response to current therapy, switching to daridorexant is safe and may be an effective alternative treatment. Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
    Trial completion:  A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women (clinicaltrials.gov) -  May 12, 2023   
    P1,  N=10, Completed, 
    Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Mar 2024 --> Mar 2025 Recruiting --> Completed
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Dayvigo (lemborexant) / Eisai
    Retrospective data, Review, Journal:  Efficacy and tolerability of pharmacological treatments for insomnia in adults: A systematic review and network meta-analysis. (Pubmed Central) -  Mar 28, 2023   
    Lemborexant and daridorexant (two ORAs) showed greater efficacy than placebo for SL, WASO, and TST, with good tolerability...Zaleplon and eszopiclone had better efficacy than placebo for TST and SQ respectively...ORAs have superior efficacy and tolerability. These findings should aid clinicians in matching risk/benefits of drugs available in their countries to insomnia symptoms.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Journal:  Daridorexant in Insomnia Disorder: A Profile of Its Use. (Pubmed Central) -  Mar 24, 2023   
    Most AEs were mild in severity and the incidence was not dose-dependent. The efficacy of daridorexant was maintained during a 12-month extension trial, with no new safety or tolerability concerns.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
    Review, Journal:  The abuse potential of lemborexant, a dual orexin receptor antagonist, according to the 8 factors of the Controlled Substances Act. (Pubmed Central) -  Mar 14, 2023   
    LEM, similar to most other prescription insomnia medications, was placed into Schedule IV. However, LEM and other drugs in the DORA class may have a lower potential for abuse as suggested by real-world postmarketing data from federal surveys and internet surveillance, and thus may have lower risks to public health than Schedule IV benzodiazepines and nonbenzodiazepine hypnotics that potentiate GABA signaling.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Viibryd (vilazodone) / AbbVie
    Enrollment change:  Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) -  Mar 9, 2023   
    P2,  N=600, Not yet recruiting, 
    However, LEM and other drugs in the DORA class may have a lower potential for abuse as suggested by real-world postmarketing data from federal surveys and internet surveillance, and thus may have lower risks to public health than Schedule IV benzodiazepines and nonbenzodiazepine hypnotics that potentiate GABA signaling. N=450 --> 600
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
    Enrollment open, Trial completion date, Trial primary completion date:  A Study to Measure Daridorexant in Breast Milk of Healthy Lactating Women (clinicaltrials.gov) -  Mar 6, 2023   
    P1,  N=10, Recruiting, 
    N=450 --> 600 Not yet recruiting --> Recruiting | Trial completion date: Feb 2023 --> May 2023 | Trial primary completion date: Feb 2023 --> May 2023
  • ||||||||||  Journal:  Drugs for chronic insomnia. (Pubmed Central) -  Jan 12, 2023   
    This second column in the series focuses on the metabolism of each of the 3 drugs by the cytochrome P450 enzyme CYP3A, guidance for using these agents in combination with drugs that are CYP3A inhibitors or inducers, and how to adjust dosing in patients with comorbid conditions such as hepatic or renal impairment. No abstract available
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Review, Journal:  Daridorexant: Comprehensive Review of A New Oral Agent for the Treatment of Insomnia. (Pubmed Central) -  Jan 6, 2023   
    However, due to the lack of large scale studies that directly compare dual orexin receptor antagonists (DORAs), there is not enough data to recommend 1 DORA over another. Daridorexant is well tolerated and has demonstrated significant reductions in LPS and WASO in the treatment of insomnia in adult patients.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Journal:  Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. (Pubmed Central) -  Dec 10, 2022   
    P3
    Treatment with daridorexant, for up to 12 months, was generally safe and well tolerated. Exploratory efficacy analyses suggest that the sustained improvements in sleep and daytime functioning with daridorexant 50 mg support its use for long-term treatment of insomnia disorder, without concerns of new safety signals.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Journal:  Possible Suicidal Risk With Daridorexant, a New Treatment for Insomnia. (Pubmed Central) -  Dec 9, 2022   
    Exploratory efficacy analyses suggest that the sustained improvements in sleep and daytime functioning with daridorexant 50 mg support its use for long-term treatment of insomnia disorder, without concerns of new safety signals. No abstract available
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
    PK/PD data, Journal:  Comparative Pharmacology of the 3 Marketed Dual Orexin Antagonists-Daridorexant, Lemborexant, and Suvorexant: Part 1: Pharmacokinetic Profiles. (Pubmed Central) -  Nov 16, 2022   
    This first column in a 2-part series focuses on the pharmacokinetics of the 3 Food and Drug Administration-approved dual orexin receptor antagonists, daridorexant, lemborexant, and suvorexant, specifically as they relate to their use as sleep medications. Although other classes of sleep medications are not discussed, the same pharmacokinetic principles also apply to them.
  • ||||||||||  Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
    Journal:  Daridorexant, a recently approved Dual Orexin Receptor Antagonists (DORA) in the treatment of insomnia. (Pubmed Central) -  Nov 15, 2022   
    Beyond the effectiveness in insomnia, it has been successfully used in patients suffering from Obstructive sleep apnoea, Chronic Obstructive Airway Disease (COAD), Alzheimer's Disease (AD), hypertension and cardiovascular disorders. Larger studies need to address the safety issues as well as obtaining robust pharmacovigilance information to safeguard the risk benefit aspect of this drug in insomniac adults.