- |||||||||| 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
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, 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) - 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, Syneos Health, Nxera Pharma, Simcere
Trial completion date, Trial primary completion date: Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder (clinicaltrials.gov) - May 12, 2023
P2, N=150, Recruiting,
Trial completion date: Jun 2023 --> Oct 2023 | Trial primary completion date: Jun 2023 --> Oct 2023 Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Mar 2024 --> Mar 2025
- |||||||||| 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, Syneos Health, Nxera Pharma, Simcere, 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
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Dayvigo (lemborexant) / Eisai, Belsomra (suvorexant) / Merck (MSD)
Journal: Comparative Pharmacology of the 3 Marketed Dual Orexin Antagonists-Daridorexant, Lemborexant, and Suvorexant-Part 2. Principal Drug Metabolizing Enzyme, Drug-Drug Interactions, and Effects of Liver and Renal Impairment on Metabolism. (Pubmed Central) - Jan 18, 2023
Although other classes of sleep medications are not discussed, the same pharmacokinetic principles also apply to them in terms of endeavoring to match the pharmacokinetics of an agent to the individual's usual sleep cycle. 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.
- |||||||||| 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.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere, Viibryd (vilazodone) / AbbVie
Trial initiation date: Department of Defense PTSD Adaptive Platform Trial - Master Protocol (clinicaltrials.gov) - Nov 14, 2022
P2, N=450, Not yet recruiting,
Because patients valued daytime functioning more than sleep latency and duration, we recommend that functional outcomes and sleep quality be considered in treatment development and evaluation. Initiation date: Oct 2022 --> Feb 2023
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
PK/PD data, Journal: Population pharmacokinetic modeling of daridorexant, a novel dual orexin receptor antagonist. (Pubmed Central) - Nov 1, 2022
Lean body weight and fat mass described the pharmacokinetics of daridorexant better than other body size descriptors (body weight, height, body mass index), suggesting a convenient physiological alternative to reduce the number of covariates in population pharmacokinetic models. The results indicate that differences between subjects do not require dose adjustments.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Trial completion date, Trial primary completion date: Dose-finding Study Assessing the Efficacy, Safety, and Pharmacokinetics of Daridorexant in Subjects Aged 10 to < 18 Years With Insomnia Disorder (clinicaltrials.gov) - Oct 18, 2022
P2, N=150, Recruiting,
The results indicate that differences between subjects do not require dose adjustments. Trial completion date: Aug 2023 --> Apr 2024 | Trial primary completion date: Jul 2023 --> Mar 2024
- |||||||||| Review, Journal: Orexin Receptor Antagonists and Insomnia. (Pubmed Central) - Oct 14, 2022
As for selective ORAs, orexin receptor 2 antagonist seltorexant still has not yet reached phase 3. High-quality clinical trials in insomnia populations are needed which directly compare authorized ORAs and investigate non-approved ORAs, the use of ORAs in comorbid insomnia, and the orexin signaling system pathophysiology in insomnia.
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
Review, Journal: Daridorexant for the treatment of insomnia disorder: findings and implications. (Pubmed Central) - Oct 12, 2022
Daridorexant was efficacious and safe. Studies that evaluate the long-term safety and compare daridorexant with benzodiazepines, benzodiazepine receptor agonists, sedative antidepressants, and other orexin receptor antagonists are required.
- |||||||||| Quviviq (daridorexant) / Idorsia, Syneos Health, Nxera Pharma, Simcere
Trial completion: A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects (clinicaltrials.gov) - Oct 12, 2022
P1, N=18, Completed,
Studies that evaluate the long-term safety and compare daridorexant with benzodiazepines, benzodiazepine receptor agonists, sedative antidepressants, and other orexin receptor antagonists are required. Recruiting --> Completed
- |||||||||| Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health
Review, Journal: Daridorexant for the Treatment of Insomnia. (Pubmed Central) - Sep 3, 2022
Daridorexant offers patients relief from insomnia while avoiding the severe side effects and dependency issues of traditional treatments like benzodiazepines and sedatives. In this article, we review the most recent data on insomnia treatments and summarize the safety and efficacy of daridorexant in treating insomnia.
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