Daridorexant (insomnia) ' Benefit assessment according to '35a Social Code Book V 1 Translation of Sections I 1 to I 6 of the dossier assessment Daridorexant (Insomnie) – Nutzenbewertung gemäß § 35a SGB V. Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding . Daridorexant (insomnia) Benefit assessment according to §35a SGB V1 EXTRACT Project: A24-24 Version: 1.0 Status: 27 May 2024 DOI: 10.60584/A24-24_en Extract of dossier assessment A24-24 Version 1.0 Daridorexant ( insomnia) 27 May 2024 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Daridorexant (insomnia
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Daridorexant (insomnia) ' Addendum to Commission A22-123 1 Translation of addendum A23-22 Daridorexant (Insomnie) – Addendum zum Projekt A22-123 (Dossierbewertung). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Daridorexant (insomnia) Addendum to Project A22-123 (dossier assessment)1 ADDENDUM Project: A23-22 Version: 1.0 Status: 21 April 2023 Addendum A23-22 Version 1.0 Daridorexant – Addendum to Project A22-123 21 April 2023 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Daridorexant (insomnia) – Addendum to Project A22-123 Commissioning agency
Daridorexant (chronic insomnia) - Benefit assessment according to ' 35a SGB V 1 Translation of Sections I 1 to I 6 of the dossier assessment Daridorexant ( Insomnie) – Nutzenbewertung gemäß § 35a SGB V. Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding . Daridorexant (insomnia) Benefit assessment according to §35a SGB V1 EXTRACT Project: A22-123 Version: 1.0 Status: 8 February 2023 Extract of dossier assessment A22-123 Version 1.0 Daridorexant ( insomnia) 8 February 2023 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher Institute for Quality and Efficiency in Health Care Topic Daridorexant (insomnia) – Benefit
Daridorexant (Quviviq) in insomnia Register online | Log in | My PrescrireISSUE CONTENTSTOPICSABOUT PRESCRIREOFFERSenglish.prescrire.org > Spotlight > 100 most recent > Daridorexant (Quviviq°) in insomniaSpotlightEvery month, the subjects in Prescrire’s Spotlight.100 most recent : 1 | 10 | 20 | 30 | 40 | 50 | 60 | 70 | 80 | 90Spotlight100 most recentArchivesDaridorexant (Quviviq°) in insomnia Marketing Authorisations The clinical evaluation of daridorexant in patients with chronic insomnia was not designed to demonstrate a potential advance compared with already available sleep-inducing drugs. While its mechanism of action is indeed different, there is no evidence that it represents a tangible clinical advance for patients.Full article (4 pages) available for download by subscribersPatients
Daridorexant (Quviviq) - insomnia 1 Published 08 April 2024 1 SMC2611 daridorexant film-coated tablets (Quviviq®) Idorsia Pharmaceuticals UK Ltd 08 March 2024 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission daridorexant (Quviviq®) is accepted for restricted use within NHSScotland. Indication under review: treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime
Daridorexant (Quviviq) - insomnia 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT QUVIVIQ 25 mg film-coated tablets QUVIVIQ 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUVIVIQ 25 mg film-coated tablets Each film-coated tablet contains daridorexant hydrochloride equivalent to 25 mg of daridorexant. QUVIVIQ 50 mg film-coated tablets Each film-coated tablet contains daridorexant hydrochloride equivalent to 50 mg of daridorexant. For the full
Pharmacokinetics, safety, and efficacy of daridorexant in Japanese subjects: Results from phase 1 and 2 studies. Daridorexant is a dual orexin receptor antagonist for the treatment of insomnia. We report results from the first two randomised, double-blind clinical studies of daridorexant in Japanese subjects. In the Phase 1 study, daridorexant (10, 25, 50 mg) or placebo were administered in the morning for 4 days in 24 young (mean age 26.9 years) and 24 older (mean age 69.7 years) healthy Japanese adults. Daridorexant reached a peak plasma concentration within 1.0 h across every dose and age group. For all doses, the mean plasma concentration of daridorexant showed a similar change between the age groups. Exposure parameters increased dose-dependently with minimal/no accumulation upon repeated
Effect of daridorexant on sleep architecture in patients with chronic insomnia disorder - A pooled post hoc analysis of two randomized Phase 3 clinical studies. Post-hoc analysis to evaluate the effect of daridorexant on sleep architecture in people with insomnia, focusing on features associated with hyperarousal. We studied sleep architecture in adults with chronic insomnia disorder from two randomized Phase 3 clinical studies (Clinicaltrials.gov: NCT03545191 and NCT03575104) investigating 3 months of daridorexant treatment (placebo, daridorexant 25 mg, daridorexant 50 mg). We analyzed sleep-wake transition probabilities, EEG spectra and sleep spindle properties including density, dispersion, and slow oscillation phase coupling. The Wake EEG Similarity Index (WESI) was determined using
Daridorexant for patients with chronic insomnia disorder: number needed to treat, number needed to harm, and likelihood to be helped or harmed. Appraise the evidence for daridorexant 50 mg and 25 mg versus placebo when treating chronic insomnia disorder in terms of number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH). NNT, NNH, and LHH were calculated from a 3-month pivotal Phase 3 study ( = 930; randomized 1:1:1 to daridorexant 50 mg, daridorexant 25 mg, or placebo once nightly). Wakefulness after sleep onset, latency to persistent sleep, self-reported total sleep time, Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), and Insomnia Severity Index were used for the NNT efficacy analysis. NNH safety analysis was performed using
Clinical safety of daridorexant in insomnia treatment: Analysis of FDA adverse event reports. Daridorexant, a novel dual orexin receptor antagonist, was approved by the FDA in 2022 for the treatment of insomnia in adults. The aim of this study is to delve into the adverse events (AEs) of daridorexant by analyzing data from the FAERS database, to assess its safety and effectiveness in clinical applications. This study selected data from the FAERS database from the first quarter of 2022 to the third quarter of 2023. Various data analysis methods were used, including the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), to assess AEs related to daridorexant. The study analyzed a total
Daridorexant in Insomnia Disorder: A Profile of Its Use. Daridorexant (Quviviq™) is a useful option for the treatment of insomnia disorder, which has shown efficacy in younger and older adults. It antagonises the orexin receptors, thereby reducing the wake drive. Daridorexant is the first dual orexin receptor antagonist to be approved for the treatment of chronic insomnia in the EU and has been approved for insomnia in the USA. In phase 3 clinical trials, daridorexant dose-dependently improved objective latency to persistent sleep, objective wake time after sleep onset, subjective total sleep time and, at the 50 mg dose, subjective daytime functioning compared with placebo. Daridorexant was generally well tolerated. Adverse events (AEs) commonly associated with insomnia drugs
Daridorexant, an Orexin Receptor Antagonist for the Management of Insomnia. Insomnia is a common sleep disorder that is diagnosed primarily by patients' subjective reported symptoms. Daridorexant is a new dual orexin receptor antagonist that was recently approved by Food and Drug Administration for insomnia characterized by difficulty falling asleep and/or maintaining sleep. The orexin trials involving study 1 and study 2. Study 1 noted daridorexant at doses of 25 and 50 mg demonstrated a statistically significant improvement in wake time after sleep onset, latency to persistent sleep, and self-reported total sleep time against placebo at months 1 and 3. Similarly in study 2, compared with placebo, the 25 mg dose demonstrated statistically significant improvement in wake time after
Effect of Daridorexant on the Pharmacokinetics of P-Glycoprotein Substrate Dabigatran Etexilate and Breast Cancer Resistance Protein Substrate Rosuvastatin in Healthy Subjects. The dual orexin receptor antagonist daridorexant was approved in 2022 for the treatment of insomnia at doses up to 50 mg once per night. This study aimed at investigating the effect of daridorexant 50 mg at steady state (Treatment A2) and 11 (Treatment C2). On days 7-14, daridorexant (50 mg once daily) was administered. Blood samples for the pharmacokinetics of both substrates and the pharmacodynamics of dabigatran, i.e., two coagulation tests, were collected and safety assessments performed. Noncompartmental pharmacokinetic parameters and pharmacodynamic variables were evaluated with geometric mean ratios and 90
Long-Term Safety and Tolerability of Daridorexant in Patients with Insomnia Disorder. Daridorexant is a dual orexin receptor antagonist for the treatment of insomnia. In two phase III, 12-week studies in patients with insomnia disorder, daridorexant improved sleep and daytime functioning while maintaining a favorable safety profile. The objective of this 40-week extension study was to assess the long-term safety and tolerability of daridorexant. Adults with insomnia disorder who completed the 12-week studies were invited to enroll in this double-blind extension study. Patients originally randomised to daridorexant (10 mg/25 mg/50 mg) remained on their respective treatments; patients randomised to placebo were re-randomised to daridorexant 25 mg or placebo. The 40-week treatment period
Meaningful Within-Patient Change on the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Analysis of Phase III Clinical Trial Data of Daridorexant. The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) is a new validated 14-item patient-reported outcome (PRO) instrument for evaluating daytime functioning in people with insomnia. It comprises three domains: Alert/Cognition , Mood, and Sleepiness. The aim of this analysis was to estimate the minimum within-patient change for IDSIQ scores that an adult patient with insomnia would consider meaningful. Data were from a randomized, double-blind, placebo-controlled, phase III clinical trial of daridorexant in adults with insomnia. Subjects completed the IDSIQ daily in the evening, with a recall period of 'today', throughout
Number, Duration, and Distribution of Wake Bouts in Patients with Insomnia Disorder: Effect of Daridorexant and Zolpidem. Daridorexant, a dual orexin receptor antagonist approved in early 2022, reduces wake after sleep onset without reducing the number of awakenings in patients with insomnia. The objective of this post hoc analysis was to explore the effect of daridorexant on the number , duration, and distribution of night-time wake bouts, and their correlation with daytime functioning. Adults with insomnia disorder were randomized 1:1:1:1:1:1 to placebo, zolpidem 10 mg, or daridorexant 5, 10, 25, or 50 mg in a phase II dose-finding study, and 1:1:1 to placebo or daridorexant 25 or 50 mg in a pivotal phase III study. We analyzed polysomnography data for daridorexant 25 and 50 mg
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. To determine if there are differences in the number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH) between lemborexant and daridorexant and to compare lemborexant with daridorexant indirectly. Dichotomous efficacy and tolerability outcomes reported for Phase 3 daridorexant trials (conducted May 29, 2018-May 14, 2020) for months 1 and 3 were identified from published literature and regulatory documents. Analogous data were extracted for lemborexant from Phase 3 studies (conducted May 31, 2016-January 8, 2019). NNT, NNH, and LHH were then calculated. Lemborexant 5 mg