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- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Belsomra (suvorexant) / Merck (MSD)
Review, Journal: Dual orexin receptor antagonists for delirium: A scoping review and feasibility trial of daridorexant. (Pubmed Central) - May 16, 2025
The evidence in support of DORAs for delirium calls for adequately powered efficacy trials. We also emphasize the importance of considering the pharmacokinetics of DORAs for delirium to maximize potential benefit and minimize the risk of next-morning sedation.
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Journal: Quantification of daridorexant, lemborexant and suvorexant in whole blood using liquid chromatography-tandem mass spectrometry. (Pubmed Central) - Apr 27, 2025
A proof-of-concept study using authentic blood samples containing suvorexant, compared to previously reported concentrations, showed no consistent decrease over time, highlighting the need for further studies to determine optimal storage conditions for long-term stability. Although further studies are needed with authentic samples containing the more novel DORAs lemborexant or daridorexant, this validated method supports broader adoption in forensic toxicology, enhancing the detection and monitoring of these emerging sedative-hypnotics in forensic investigations.
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Preclinical, Journal: Effects of daridorexant on rest/wake activity patterns and drinking in adult rats exposed to chronic ethanol vapor in adolescence. (Pubmed Central) - Apr 6, 2025
Additionally, we did not find a significant difference in drinking behavior in animals treated with the orexin antagonist. Thus, it appears that data from this animal model do not support the use of this drug to improve adolescent alcohol-induced sleep disturbance and/or to decrease alcohol drinking.
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Journal, HEOR, Cost-effectiveness: Cost-Effectiveness Analysis of Daridorexant for the Pharmacological Treatment of Chronic Insomnia Disorder in Adults. (Pubmed Central) - Mar 28, 2025
Thus, it appears that data from this animal model do not support the use of this drug to improve adolescent alcohol-induced sleep disturbance and/or to decrease alcohol drinking. Daridorexant 50
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Journal: A Preliminary Report on the Effects of Daridorexant in Patients with Comorbid Insomnia and Substance Use Disorders. (Pubmed Central) - Mar 27, 2025
These preliminary findings suggest that daridorexant might represent a promising tool for treating insomnia in patients with SUDs. Identifying interventions effectively targeting insomnia with a good safety/tolerability profile in SUDs is crucial to achieve remission and full functional recovery.
- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Dayvigo (lemborexant) / Eisai
Retrospective data, Review, Journal: Comparison of efficacy and safety of dual orexin receptor antagonists lemborexant and daridorexant for the treatment of insomnia: a systematic review and meta-analysis. (Pubmed Central) - Mar 26, 2025
The choice between LEM and DAR should consider individual patient needs, including the risk of daytime drowsiness and other adverse events. Further direct comparative trials are needed to confirm these findings and inform clinical decision-making.
- |||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Enrollment status, Trial completion date: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada (clinicaltrials.gov) - Mar 17, 2025
P=N/A, N=100, Enrolling by invitation, Sponsor: PeriPharm
Further direct comparative trials are needed to confirm these findings and inform clinical decision-making. Recruiting --> Enrolling by invitation | Trial completion date: Dec 2024 --> Oct 2025
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Trial completion: Daridorexant to Prevent Delirium After Heart Surgery (clinicaltrials.gov) - Mar 10, 2025
P2, N=11, Completed, Sponsor: University of Rochester
Recruiting --> Enrolling by invitation | Trial completion date: Dec 2024 --> Oct 2025 Enrolling by invitation --> Completed
- || Cobenfy (xanomeline/trospium) / BMS, Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Review, Journal: Psychiatric drug development on the verge of its Rubicon (Pubmed Central) - Mar 7, 2025
Altogether, psychiatric drug development is currently undergoing something of a renaissance, but relevant stakeholders seem unable to address the shortcomings and pitfalls of the current approach, risking psychiatric drug development to fall even further behind. Improving drug development in psychiatry is only possible if clinicians, researchers, drug developers and regulators join forces in a concerted effort to address these issues.
- ||| eszopiclone / Generic mfg., Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, zaleplon / Generic mfg.
Clinical guideline, Review, Journal: Clinical practice guidelines for switching or deprescribing hypnotic medications for chronic insomnia: Results of European neuropsychopharmacology and sleep expert's consensus group. (Pubmed Central) - Mar 2, 2025
Improving drug development in psychiatry is only possible if clinicians, researchers, drug developers and regulators join forces in a concerted effort to address these issues. Discontinuation of Hypnotic Benzodiazepines and Z-drugs should be gradual, with dose reductions of 10-25
- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Belsomra (suvorexant) / Merck (MSD)
Review, Journal: Role of OX/OXR cascade in insomnia and sleep deprivation link Alzheimer's disease and Parkinson's disease: Therapeutic avenue of Dual OXR Antagonist (DORA). (Pubmed Central) - Feb 23, 2025
deposition in the brain and improves synaptic plasticity and circadian expression. This review indicates the link between sleep disorders and MCI, DORAs are an appropriate medication category for treating insomnia, and sleep deprivation links AD and PD.
- ||| Ereska (ketamine intranasal) / Seelos Therap, Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Viibryd (vilazodone) / AbbVie
Enrollment change: Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) - Feb 11, 2025
P2, N=800, Recruiting, Sponsor: Global Coalition for Adaptive Research
This review indicates the link between sleep disorders and MCI, DORAs are an appropriate medication category for treating insomnia, and sleep deprivation links AD and PD. N=600 --> 800
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Observational data, Journal: Effect of graduated drug therapy for moderate to severe chronic insomnia on the severity of disease: an observational study in Germany. (Pubmed Central) - Jan 6, 2025
A significant number of patients already responded favorably to mild sleep medications, whereas others demonstrated a need for more potent treatments. Ongoing monitoring will evaluate the long-term effectiveness of both approaches.
- |||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Enrollment open: Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ (clinicaltrials.gov) - Dec 18, 2024
P=N/A, N=785, Recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
Ongoing monitoring will evaluate the long-term effectiveness of both approaches. Not yet recruiting --> Recruiting
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Journal: Nighttime safety of daridorexant: Evaluation of responsiveness to an external noise stimulus, postural stability, walking, and cognitive function. (Pubmed Central) - Dec 6, 2024
P1
Following bedtime administration, daridorexant maintained the ability to awaken to an external noise stimulus in the middle of the night, allowing subjects to function safely. NCT05702177.
- || 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
Journal: Early experience with the new DORA daridorexant in patients with insomnia disorder and comorbid mental disturbances: Results of a naturalistic study with 3?months follow-up. (Pubmed Central) - Nov 26, 2024
Multiple-regression models showed that clinical improvement of Beck Depression Inventory-II was best predicted by improvement in Dysfunctional Beliefs About Sleep at T1 and T2, manic symptoms by Insomnia Severity Index at T2, anxiety symptoms by Dysfunctional Beliefs About Sleep, Insomnia Severity Index and somatic Pre-Sleep Arousal Scale at T1 and T2. With the caution of a naturalistic design, early experience with daridorexant showed that by targeting insomnia it may be possible to improve not only insomnia symptoms but also comorbid symptoms.
- || Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Retrospective data, Review, Journal: The efficacy and safety of dual orexin receptor antagonists in obstructive sleep apnea: A systematic review and meta-analysis of randomised controlled trials. (Pubmed Central) - Nov 17, 2024
Furthermore, DORAs were not associated with significantly higher adverse effects compared with placebo. This meta-analysis demonstrated that DORAs improve sleep and do not impair nighttime respiratory function in patients with OSA.
- ||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
P3 data, Retrospective data, Journal: Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder - A pooled post hoc analysis of two randomized Phase 3 clinical studies. (Pubmed Central) - Nov 13, 2024
P3
This meta-analysis demonstrated that DORAs improve sleep and do not impair nighttime respiratory function in patients with OSA. 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.
- | 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, Sponsor: University of Rochester
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, Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
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
New P2 trial: Daridorexant to Prevent Delirium After Heart Surgery (clinicaltrials.gov) - Oct 8, 2024
P2, N=12, Not yet recruiting, Sponsor: University of Rochester
- |||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Enrollment open, Real-world evidence: 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, Sponsor: PeriPharm
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
P2 data, Journal: Dose-response of daridorexant in insomnia disorder: An analysis of Phase 2 and 3 studies. (Pubmed Central) - Aug 17, 2024
We identified some potential ADE signals that can promote the rational use of DORAs and improve their safety. The data support the use of 50
- ||| 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
- || Clinical data, FDA event, NDA, Preclinical, Journal: Risk of Enzyme- and Transporter-Mediated Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2022: A Detailed Analysis of In Vitro and Clinical Data Available in New Drug Application Reviews. (Pubmed Central) - Jul 28, 2024
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 The mechanistic information obtained from studying these new therapeutics with marker compounds can be extrapolated to common concomitant medications sharing the same pharmacokinetic properties, enhancing the safe and effective administration of these products in situations of polytherapy.
- |||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
New trial: Registry to Collect Information on Pregnancy, Neonatal, and Infant Outcomes in Pregnant Women Exposed to QUVIVIQ (clinicaltrials.gov) - Jul 12, 2024
P=N/A, N=785, Not yet recruiting, Sponsor: Idorsia Pharmaceuticals Ltd.
- | Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Journal: Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. (Pubmed Central) - Jun 20, 2024
Daridorexant 50?mg and 25?mg have a favorable benefit - risk ratio over 3?months. Daridorexant 50?mg demonstrated more robust (lower) NNT estimates versus placebo than daridorexant 25?mg.
- ||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Journal, Adverse events: Association between dual orexin receptor antagonists (DORAs) and suicidality: reports to the united states food and drug administration adverse event reporting system (FAERS). (Pubmed Central) - May 28, 2024
We did not find a significant association between any parameter of suicidality captured in the FAERS for each DORA. All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect.
- ||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere
Trial completion: A Post Approval Study to Investigate the Efficacy of Daridorexant in Subjects With Insomnia and Comorbid Nocturia (clinicaltrials.gov) - May 22, 2024
P4, N=60, Completed, Sponsor: Idorsia Pharmaceuticals Ltd.
All persons treated for insomnia pharmacologically/non-pharmacologically should be evaluated for emergence/worsening of any suicidality aspect. Active, not recruiting --> Completed
- | 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, Sponsor: Idorsia Pharmaceuticals Ltd.
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei, Simcere, midazolam hydrochloride / Generic mfg., warfarin / Generic mfg.
PK/PD data, Journal: Effect of Daridorexant on the Pharmacokinetics of Midazolam, and on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Male Subjects. (Pubmed Central) - Apr 24, 2024
P1
Daridorexant at 50 mg is classified as a weak CYP3A4 inhibitor after single- and multiple-dose administration once daily at steady state. Daridorexant 50 mg did not induce CYP3A4 activity or inhibit CYP2C9 activity.
- ||| 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, Sponsor: University Hospital, Montpellier
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, Mochida, Syneos Health, Sosei
New P1 trial: Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects (clinicaltrials.gov) - Mar 22, 2024
P1, N=32, Completed, Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
- || Retrospective data, Review, Journal: Orexin Receptor Antagonists as Adjunct Drugs for the Treatment of Depression: A Mini Meta-Analysis. (Pubmed Central) - Mar 18, 2024
Considering the physiological effects of orexin on behaviors, ORAs may be promising new treatment modalities in the treatment of many psychiatric disorders other than insomnia. However, these results are preliminary and further studies with different ORAs at different doses and with different samples are needed.
- |||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
New trial, Real-world evidence: 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, Sponsor: PeriPharm
- || 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, Sponsor: Idorsia Pharmaceuticals Ltd.
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, Syneos Health, Nxera Pharma, Simcere
Enrollment open: A Study of Daridorexant in Chinese Patients With Insomnia Disorder (clinicaltrials.gov) - Dec 19, 2023
P3, N=200, Recruiting, Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- || Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Sosei
Review, Journal: Evaluation and management of insomnia in the clinical practice in Italy: a 2023 update from the Insomnia Expert Consensus Group. (Pubmed Central) - Dec 8, 2023
The choice of the drug should be based on different factors including type of insomnia, age, comorbidities, and potential side effects. If the choice would be a Z-drug or a short-acting benzodiazepine (in subjects?<?65
- || 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.