Quviviq (daridorexant) / Idorsia, Mochida, Syneos Health, Nxera Pharma, Simcere, Shionogi, Holling Bio-Pharma - LARVOL DELTA

Daridorexant to Prevent Post-cardiotomy Delirium (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: University of Rochester | Enrolling by invitation ➔ Recruiting

Enrollment status • CNS Disorders

DOREA: Dual Orexin Antagonism and Emotion and Affective Processing Study (clinicaltrials.gov) - P4 | N=62 | Recruiting | Sponsor: University of Oxford

New P4 trial

Exploratory study evaluating nightly daridorexant in patients with chronic migraine and comorbid insomnia (DORMI Study) (EHF-EHC 2025) - "Descriptive statistics, together with paired t-tests and measures of variance, will be used for analysis We anticipate improvement in migraine-free days and lower scores for ISI and migraine disability scores with this intervention. Should this pilot reveal clinically meaningful improvements in sleep and headache frequency, it would warrant further investigation through a larger, randomized controlled trial."

Clinical • CNS Disorders • Insomnia • Migraine • Pain • Sleep Disorder

Current and novel dual orexin receptor antagonists for the treatment of insomnia: the emergence of vornorexant. (PubMed, Int J Neuropsychopharmacol) - "As an alternative target to generate novel hypnotics, the orexin system has recently gained much attention, and 3 dual orexin receptor antagonists (DORAs)-suvorexant, lemborexant, and daridorexant-were launched. Indeed, it has shown rapid sleep-promoting effects in patients with insomnia, maintaining its activity throughout the night but having a low incidence of next-day residual effects. In this review, we first provide an overview of the role of the orexin system in sleep/wake balance and then describe the profile of a newly developed DORA, vornorexant, from drug discovery to clinical results."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Real-World Effectiveness and Safety of Daridorexant in Japanese Patients With Insomnia: A Multicenter Observational Study Evaluating Four-Week Changes in Athens Insomnia Scale Among 54 Participants. (PubMed, Cureus) - "Improvements in daily function and a favorable safety profile were also observed in this participant population. These findings should be interpreted with caution, given the study's limitations, including a small sample size (n=54), short follow-up (four weeks), single-arm, and pre-post observational design."

Journal • Observational data • Real-world evidence • CNS Disorders • Depression • Insomnia • Mental Retardation • Mood Disorders • Psychiatry • Schizophrenia • Sleep Disorder

Navigating Reimbursement Challenges for Pharmacological Interventions in Celiac Disease: Lessons From Analogous Conditions (ISPOR-EU 2025) - "This research aimed to identify potential reimbursement challenges for CD drugs, draw parallels from Health Technology Assessment (HTA) reports of drugs for analogous conditions where lifestyle, non-pharmacologic therapy is a primary comparator, and propose strategies to address these challenges. A comprehensive review of published HTA reports from agencies in England, Canada, and France was conducted, focusing on drugs for obesity (Semaglutide) and insomnia (Daridorexant)... In conclusion, navigating the complex reimbursement landscape for emerging CD drugs requires a robust strategic approach. Key strategies to address identified challenges include integrating therapy with specialist multidisciplinary services, conducting comprehensive long-term clinical and economic studies (prioritizing quality of life, complication rates, and nutritional status), highlighting broader societal and economic benefits, engaging actively with patient groups and clinicians, and exploring..."

Reimbursement • US reimbursement • Celiac Disease • CNS Disorders • Genetic Disorders • Immunology • Insomnia • Obesity • Sleep Disorder

Simcere plans to produce daridorexant, a dual orexin receptor antagonist, at its plant in Hainan province, which has been inspected by the US Food and Drug Administration and the European Medicines Agency, and export it to Idorsia's global markets, the Nanjing-based company said at the CIIE, noting that it will keep exclusive rights to the drug in China. (Yicai Global)

Commercial • Insomnia

A Randomized, Open-Label, Positive-Controlled Study on the Efficacy and Safety of Daridorexant, a GABA-A Receptor Partial Agonist, in the Treatment of Patients with Recurrent Depression Complicated by Insomnia (ChiCTR) - P4 | N=80 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New P4 trial • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Dual orexin receptor antagonists in insomnia: Toward a new therapeutic paradigm. (PubMed, Pharmacol Biochem Behav) - "Although three dual orexin receptor antagonists (DORAs), suvorexant, lemborexant, and daridorexant, are currently available and widely used to treat insomnia, the differences in their elimination half-lives are not sufficient. However, several challenges remain to be addressed in order to fully realize the clinical potential of DORAs. This review identifies four key challenges requiring resolution to advance their optimal use in clinical practice."

Journal • CNS Disorders • Insomnia • Sleep Disorder

Daridorexant to Prevent Post-cardiotomy Delirium (clinicaltrials.gov) - P2 | N=80 | Enrolling by invitation | Sponsor: University of Rochester

New P2 trial • CNS Disorders

Efficacy and safety profiles of FDA-approved dual orexin receptor antagonists in depression: A systematic review of pre-clinical and clinical studies. (PubMed, J Psychiatr Res) - "DORAs show potential in improving sleep parameters in individuals with MDD. While their effects on depressive symptoms in this review are modest, further research is needed to assess long-term efficacy, safety, and their impact on depressive symptoms, as well as to explore potential combination therapies."

FDA event • Journal • Preclinical • Review • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Psychiatry • Sleep Disorder

Efficacy and safety of insomnia pharmacotherapies: Convergent evidence from Bayesian network meta-regression and FAERS-based disproportionality analysis. (PubMed, Sleep Med) - "Comprehensively considering the efficacy effect size, time windows (follow-up period, age, and types of insomnia), PV, severity of imperative adverse events, we propose prioritizing the use of daridorexant 25 mg/d for insomnia characterized by difficulty maintaining sleep and insufficient sleep duration. For insomnia characterized by difficulty falling asleep, we recommend prioritizing the use of lemborexant 10 mg/day or zolpidem 10 mg/day. For overall poor sleep efficiency, we recommend using lemborexant. Drug selection should be based on the types of insomnia and drug safety. More head-to-head clinical trials are needed to confirm those findings."

Journal • Review • CNS Disorders • Insomnia • Pulmonary Disease • Sleep Disorder

PAD-DORA: Daridorexant for Alzheimer Disease Prevention (clinicaltrials.gov) - P2 | N=240 | Not yet recruiting | Sponsor: Douglas Mental Health University Institute

New P2 trial • Alzheimer's Disease • CNS Disorders • Plasma Aβ40

The dual orexin receptor antagonist daridorexant for insomnia treatment among alcohol dependent patients (a case series) (ECNP 2025) - "A case report from Australia on the use of another dual orexin receptor antagonist suvorexant, for the treatment of comorbid alcohol use disorder and insomnia demonstrated improvements in alcohol cravings, physical and psychological health, and sleep outcomes over time [3]...The baseline urine test for the first two patients was negative for amphetamines, barbiturates, tetrahydrocannabinol, cocaine, methadone, and other opiates; whereas benzodiazepines were positive due to medically supervised benzodiazepine-assisted withdrawal treatment...These three cases showed improvement in sleep with daridorexant treatment without relapse. Their craving scores were mixed at 21 days but improved at 42 days."

Clinical • Addiction (Opioid and Alcohol) • CNS Disorders • Depression • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

Effect of dual orexin receptor antagonists on sleep: A systematic review and meta analysis (ECNP 2025) - "The DORAs included were suvorexant, lemborexant, daridorexant, seltorexant, filorexant and vornorexant. Most DORAs were found to be of robust efficacy, irrespective of diagnosis, although further research is required for most diagnoses. Most DORAs seem to cause notably more somnolence than placebo, which is of great clinical importance."

Retrospective data • Review • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Insomnia • Major Depressive Disorder • Mood Disorders • Movement Disorders • Psychiatry • Restless Legs Syndrome • Sleep Disorder

"I can't sleep!": insomnia as the most common non-organic sleep disorder (PubMed, Inn Med (Heidelb)) - "The authors recommend step-by-step treatment, starting with mild sleep-promoting agents such as melatonin and progressing to hypnotics such as daridorexant. Drug therapy is successful when it is used in a targeted manner and under medical supervision. Since the care situation for people with insomnia is inadequate, there is a need for more education of those affected and the medical profession, as well as collaboration between family doctors, general practitioners, specialists, and sleep medicine physicians."

Journal • Review • CNS Disorders • Insomnia • Sleep Disorder

The role of daridorexant in managing chronic insomnia: efficacy and sustained safety outcomes (ECNP 2025) - "Daridorexant represents an effective and well-tolerated pharmacological intervention for chronic insomnia. It enhances objective sleep parameters—particularly by extending total sleep time, reducing sleep latency, and limiting prolonged nocturnal awakenings. The combination of a favourable safety profile and minimal risk of dependence highlights daridorexant as a compelling candidate for long-term therapeutic use in clinical practice."

Clinical • CNS Disorders • Cognitive Disorders • Insomnia • Psychiatry • Sleep Disorder

Successful management of refractory insomnia in a patient with intellectual disability using daridorexant: a case report (ECNP 2025) - "This case underscores the promising potential of Daridorexant as an effective and well-tolerated treatment option for insomnia in adults with intellectual disability and behavioral challenges. Its unique mechanism of action offers advantages over traditional sedatives"

Case report • Clinical • Alzheimer's Disease • Behavior Disorders • CNS Disorders • Cognitive Disorders • Insomnia • Mental Retardation • Mood Disorders • Psychiatry • Sleep Disorder

Craving control: The role of orexins in eating disorders and implications for treatment (ECNP 2025) - "Orexin-agents are still an underexplored treatment option: in Europe, daridorexant was approved for insomnia, yet it is still not commercialized in many countries...Expanding knowledge on the orexin system and its effects on human brains should be a priority, especially when it shows so much promise in the ED field – a chronically unappreciated area within psychiatry, that despite its high prevalence and morbidity still lacks effective psychopharmacological options. If we are to help patients regain control of their appetites, we must first nourish the research that understands what drives them."

Anorexia • Binge Eating Disorder • Bulimia • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

Efficacy of daridorexant in treating jet lag-related sleep disorders: a clinical case report (ECNP 2025) - "Its non-sedative mechanism of action contributed to improved sleep quality and daytime functioning without compromising safety. While these findings are encouraging, further controlled studies with larger sample sizes are necessary to validate these results."

Case report • Clinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Excessive Daytime Sleepiness • Insomnia • Psychiatry • Sleep Disorder

Targeting the Orexin System in the Pharmacological Management of Insomnia and Other Diseases: Suvorexant, Lemborexant, Daridorexant, and Novel Experimental Agents. (PubMed, Int J Mol Sci) - "Clinical trials have shown that these agents significantly reduce sleep latency and enhance sleep continuity, with a favorable side effect profile. Overall, DORAs represent a distinct and clinically advantageous option for insomnia treatment, with growing interest in their potential utility across mood, anxiety, and neurodegenerative disorders."

Journal • Review • CNS Disorders • Insomnia • Mood Disorders • Psychiatry • Sleep Disorder

A Study to Evaluate the Efficacy and Safety of Daridorexant in Participants With Insomnia Disorder (clinicaltrials.gov) - P3 | N=160 | Active, not recruiting | Sponsor: Nxera Pharma Korea Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Insomnia • Sleep Disorder

Hypocretin: a promising target for the regulation of homeostasis. (PubMed, Front Neurosci) - "Dual hypocretin receptor antagonists (DORAs), such as suvorexant and daridorexant, are clinically approved for insomnia. Selective HCRT-2R agonists-including TAK-861 and ALKS-2680-are in clinical trials for NT1 and show encouraging results. Additionally, HCRT-2R antagonists like seltorexant are being explored for major depressive disorder. This review will highlight the anatomical distribution, receptor mechanisms, and physiological functions of the hypocretin system. It will also focus to discuss its role in narcolepsy, metabolic regulation, and mood disorders, while addressing key challenges and open questions that must be resolved to fully harness hypocretin's therapeutic potential."

Journal • Review • Cataplexy • CNS Disorders • Depression • Excessive Daytime Sleepiness • Insomnia • Major Depressive Disorder • Mood Disorders • Narcolepsy • Psychiatry • Sleep Disorder • LEP

Efficacy and safety of daridorexant in women with insomnia disorder during menopausal transition: a subgroup analysis (WSS 2025) - P3 | "These post-hoc exploratory analyses suggest that daridorexant 50 mg improves sleep outcomes and daytime functioning and is well tolerated in women aged 47-55 years with insomnia disorder."

Clinical • CNS Disorders • Fatigue • Insomnia • Sleep Disorder

Efficacy and safety of daridorexant in patients with chronic insomnia disorder and comorbid nocturia (WSS 2025) - "In patients with insomnia and comorbid nocturia, daridorexant improves sleep, daytime functioning and nocturia symptoms, with no increased risk of falls or urinary incontinence."

Clinical • CNS Disorders • Insomnia • Sleep Disorder • Urinary Incontinence • Urology