Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials

  title={Safety and efficacy of daridorexant in patients with insomnia disorder: results from two multicentre, randomised, double-blind, placebo-controlled, phase 3 trials},
  author={Emmanuel Jean-Marie Mignot and David W. Mayleben and Ingo Fietze and Damien L{\'e}ger and Gary Zammit and Claudio L. A. Bassetti and Scott Pain and Dalma Seboek Kinter and Thomas Roth},
  journal={The Lancet Neurology},

Efficacy and Safety of Daridorexant in Older and Younger Adults with Insomnia Disorder: A Secondary Analysis of a Randomised Placebo-Controlled Trial

In older patients with insomnia, as in younger patients, the efficacy of daridorexant is maximal on night-time and daytime variables at the higher dose of 50 mg, and older patients particularly require this dose to improve daytime functioning.

Daridorexant for the treatment of insomnia disorder: findings and implications

Daridorexant 25 and 50 mg had more significant improvement for the wake after sleep onset (WASO), latency to persistent sleep (LPS), and subjective total sleep time (sTST) than placebo.

Daridorexant for the Treatment of Insomnia.

Daridorexant is a dual orexin type 1 and types 2 (OX1 and OX2) receptor antagonist that was recently approved by the US FDA for the treatment of adults suffering from insomnia and was shown to be effective in reducing insomnia symptoms, increasing daytime functioning, and improving the overall quality of sleep.

Orexin Receptor Antagonists and Insomnia

We review recent evidence on the use of orexin receptor antagonists (ORAs) for treating insomnia. We evaluate studies on five dual ORAs and one selective ORA. Research on suvorexant in recent years

A Comprehensive Review of Daridorexant, a Dual-Orexin Receptor Antagonist as New Approach for the Treatment of Insomnia

The use of daridorexant is considered safe, with no clinically significant side-effects including deprivation of next-morning residual effects, including pharmacodynamics, animal and human research, pharmacokinetics and safety.

Daridorexant: First Approval

Daridorexant was recently approved in the USA for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance.

Newly FDA-approved psychotropic medications.

What evidence is there for implicating the brain orexin system in neuropsychiatric symptoms in dementia?

An overview of the behavioral domains influenced by the orexin system that may be relevant for the expression of some critical NPS in PwD are presented and the potential effects of pharmacological interference with the oRexin system are hypothesized.

FDA-Approved Small Molecules in 2022: Clinical Uses and Their Synthesis

This review describes the recently FDA-approved drugs (in the year 2022) and comprises classical chemical scaffolds together with innovative drugs such as a deuterium-containing drug.

Recent Advances in Psychopharmacology



Daridorexant, a new dual orexin receptor antagonist, in elderly subjects with insomnia disorder

Dose-dependent improvements in WASO and LPS were statistically significant (dose range 10–50 mg) in elderly people with insomnia disorder, and daridorexant was well tolerated.

Acute Cognitive Effects of the Hypocretin Receptor Antagonist Almorexant Relative to Zolpidem and Placebo: A Randomized Clinical Trial.

The data provide support for the hypothesis that hypocretin receptor (Hcrt) antagonists produce less functional impairment than a benzodiazepine receptor agonist (BzRA).

Lemborexant vs suvorexant for insomnia: A systematic review and network meta-analysis.

Development and Validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)

These studies, which closely followed Food and Drug Administration Guidance for Industry on patient-reported outcome measures, support use of the IDSIQ as a fit-for-purpose measure for deriving valid and reliable endpoints in insomnia clinical research trials and real-world studies.

Subjective versus objective evaluation of hypnotic efficacy: experience with zolpidem.

The polysomnographic findings indicated a shortened sleep latency, increased total sleep time, decreased total wake time and increased sleep efficiency when patients ingested zolpidem 30 minutes before bedtime, and the PSG remains the keystone in the evaluation of hypnotic efficacy.

Clinical guideline for the evaluation and management of chronic insomnia in adults.

This clinical guideline is to provide clinicians with a practical framework for the assessment and disease management of chronic adult insomnia, using existing evidence-based insomnia practice parameters where available, and consensus-based recommendations to bridge areas where such parameters do not exist.

Differential sleep-promoting effects of dual orexin receptor antagonists and GABAA receptor modulators

The ability of DORAs to promote proportional NREM and REM sleep following sleep deprivation suggests that this mechanism may be effective in alleviating recovery from sleep disturbance.

European guideline for the diagnosis and treatment of insomnia

This European guideline for the diagnosis and treatment of insomnia was developed by a task force of the European Sleep Research Society, with the aim of providing clinical recommendations for the