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Daridorexant

This article examines the use of daridorexant, a promising new drug, in clinical trials for the treatment of insomnia. Daridorexant is being studied in various populations, including adults, elderly individuals, and even children with insomnia disorder. The trials aim to assess the drug’s efficacy, safety, and pharmacokinetics, as well as its effects on sleep parameters and daytime functioning. We’ll explore the key findings from these studies and what they mean for potential future insomnia treatments.

Table of Contents

What is Daridorexant?

Daridorexant, also known by its brand name Quviviq[1], is a medication developed to treat insomnia disorder. It belongs to a class of drugs called dual orexin receptor antagonists (DORAs)[2]. Daridorexant is designed to help people who have difficulty falling asleep or staying asleep throughout the night.

What Conditions Does Daridorexant Treat?

Daridorexant is primarily used to treat insomnia disorder[3]. Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or both, despite having adequate opportunity for sleep. This can lead to daytime fatigue, mood disturbances, and impaired cognitive function.

Additionally, research is being conducted to explore its potential benefits in patients with:

  • Insomnia with comorbid nocturia: This condition involves frequent nighttime urination that disrupts sleep[4].
  • Obstructive Sleep Apnea (OSA): A disorder where breathing repeatedly stops and starts during sleep[5].

How Does Daridorexant Work?

Daridorexant works by blocking the action of orexin, a neurotransmitter in the brain that plays a crucial role in regulating the sleep-wake cycle. By inhibiting orexin, daridorexant helps to promote sleep[2]. This mechanism of action is different from older sleep medications, which often work by broadly depressing the central nervous system.

Dosage and Administration

Daridorexant is available as film-coated tablets for oral use. The most common doses studied are:

  • 10 mg
  • 25 mg
  • 50 mg

The medication is typically taken once daily in the evening, approximately 30 minutes before bedtime[1][6]. It’s important to follow your doctor’s instructions regarding the dosage and timing of daridorexant.

Efficacy of Daridorexant

Clinical trials have shown that daridorexant can improve several aspects of sleep, including:

  • Wake After Sleep Onset (WASO): This measures the amount of time spent awake after initially falling asleep. Daridorexant has been shown to reduce WASO, indicating improved sleep maintenance[2].
  • Latency to Persistent Sleep (LPS): This is the time it takes to fall into a continuous sleep state. Daridorexant can help reduce LPS, meaning patients fall asleep faster[2].
  • Total Sleep Time (TST): Studies have shown an increase in the total amount of time patients sleep when taking daridorexant[2].
  • Daytime Functioning: Improvements in daytime sleepiness and overall functioning have been reported by patients using daridorexant[2].

Safety and Side Effects

While daridorexant is generally well-tolerated, like all medications, it can cause side effects. The most common side effects reported in clinical trials include:

  • Headache
  • Dizziness
  • Fatigue
  • Nausea

Long-term safety studies are ongoing to further evaluate the safety profile of daridorexant[6]. It’s important to discuss any side effects you experience with your healthcare provider.

Use in Special Populations

Research is being conducted to understand the effects of daridorexant in various populations:

  • Pediatric patients: Studies are underway to assess the efficacy, safety, and appropriate dosing of daridorexant in children and adolescents aged 10 to 18 years with insomnia disorder[7].
  • Lactating women: Research is being done to measure the presence of daridorexant in breast milk, which will help determine its safety for use in breastfeeding mothers[8].
  • Elderly patients: Clinical trials have included elderly subjects to ensure the medication’s safety and efficacy in this population[2].

Ongoing Research

Several studies are currently in progress to further understand the effects of daridorexant:

  • Its impact on nighttime breathing in patients with obstructive sleep apnea[5].
  • Effects on body posture, auditory awakening threshold, and cognitive function when waking up in the middle of the night[1].
  • Its efficacy in treating insomnia with comorbid nocturia[4].
  • Pharmacokinetics (how the drug moves through the body) in different populations, including Chinese subjects[9].

These ongoing studies will provide more information about the long-term effects, safety, and potential additional uses of daridorexant in the future.

Aspect Details
Drug Name Daridorexant (also known as ACT-541468)
Indications Insomnia Disorder, Obstructive Sleep Apnea
Dosages Studied 10 mg, 25 mg, 50 mg
Administration Oral tablets, taken once daily in the evening
Primary Outcomes Wake After Sleep Onset (WASO), Latency to Persistent Sleep (LPS), Subjective Total Sleep Time (sTST)
Secondary Outcomes Daytime functioning, safety, pharmacokinetics
Study Populations Adults, elderly, children/adolescents (10-18 years), lactating women, patients with obstructive sleep apnea
Study Designs Randomized, double-blind, placebo-controlled, parallel-group, crossover
Assessment Methods Polysomnography, sleep diaries, questionnaires (e.g., IDSIQ), pharmacokinetic sampling
Study Durations Range from single-dose studies to 3-month treatment periods

FAQ

  • What is daridorexant? Daridorexant is a new drug being studied for the treatment of insomnia disorder. It belongs to a class of medications called dual orexin receptor antagonists, which work by blocking the action of orexin, a neurotransmitter involved in wakefulness.
  • What are the main outcomes being measured in daridorexant clinical trials? The main outcomes being measured include changes in sleep parameters such as Wake After Sleep Onset (WASO), Latency to Persistent Sleep (LPS), Total Sleep Time (TST), and subjective measures of sleep quality. Additionally, researchers are assessing daytime functioning, safety, and pharmacokinetics of the drug.
  • What dosages of daridorexant are being studied? Various dosages of daridorexant are being studied in clinical trials, including 10 mg, 25 mg, and 50 mg. Some trials are comparing different dosages to determine the most effective and safe dose for treating insomnia.
  • Are there any special populations being studied in daridorexant trials? Yes, daridorexant is being studied in diverse populations. There are trials focusing on adults and elderly individuals with insomnia disorder, as well as studies involving children and adolescents aged 10 to 18 years. Some trials are also looking at specific groups such as lactating women and patients with obstructive sleep apnea.
  • How long do the daridorexant clinical trials typically last? The duration of daridorexant clinical trials varies depending on the study design and objectives. Some trials last for a few days or weeks, while others extend up to several months. For example, one study assessed outcomes at 1 month and 3 months of treatment, while another trial lasted for 28 consecutive nights.

Ongoing Clinical Trials on Daridorexant

  • Study on Daridorexant for Treating Bedwetting in Adolescents

    Recruiting

    1 1 1
    Investigated drugs:
    Denmark

  • Study on Daridorexant’s Effect on Cognitive Performance in Patients with Chronic Insomnia Disorder

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

  • Study of daridorexant and buprenorphine combination treatment for patients with opioid use disorder

    Recruiting

    1 1
    Investigated drugs:
    Sweden

  • Study of Daridorexant for Treating Insomnia in Patients with Mild Cognitive Impairment and Mild to Moderate Alzheimer’s Disease

    Recruiting

    1 1 1
    Investigated drugs:
    France

  • Daridorexant for Insomnia in Patients with Major Depressive Disorder and Moderate to Severe Insomnia

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study to Determine Safe and Effective Dose of Daridorexant for Treating Insomnia in Children and Adolescents Aged 10 to 18 Years

    Not recruiting

    1 1
    Investigated drugs:
    Bulgaria Germany Italy Spain

  • Study on Daridorexant for Treating Insomnia in Patients with Insomnia and Nocturia

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Spain

Glossary

  • Polysomnography (PSG): A comprehensive sleep study that records brain waves, blood oxygen levels, heart rate, breathing, eye and leg movements during sleep. It's used to diagnose sleep disorders and measure sleep parameters objectively.
  • Wake After Sleep Onset (WASO): The amount of time spent awake after initially falling asleep. It's a measure of sleep maintenance and is typically assessed using polysomnography.
  • Latency to Persistent Sleep (LPS): The time it takes from the start of a sleep opportunity (usually when lights are turned off) to the beginning of persistent sleep, typically defined as the first 10 minutes of continuous sleep.
  • Pharmacokinetics: The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion. This helps researchers understand how the body processes the medication.
  • Bioequivalence: A comparison of the biological equivalence of different formulations of a drug, ensuring that they have the same effect in the body. This is important when developing different dosage forms or strengths of a medication.
  • Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): A validated patient-reported outcome measure used to assess the daytime impacts of insomnia, including sleepiness, mood, and cognitive function.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active ingredient. It's used as a control in clinical trials to help determine the true effects of the study drug.
  • Crossover Study: A type of clinical trial where participants receive different treatments in a specific order, allowing each person to serve as their own control and compare the effects of different treatments.

References

  1. https://clinicaltrials.gov/study/NCT05702177
  2. https://clinicaltrials.gov/study/NCT03575104
  3. https://clinicaltrials.gov/study/NCT06010693
  4. https://clinicaltrials.gov/study/NCT05597020
  5. https://clinicaltrials.gov/study/NCT05458193
  6. https://clinicaltrials.gov/study/NCT03679884
  7. https://clinicaltrials.eu/trial/study-to-determine-safe-and-effective-dose-of-daridorexant-for-treating-insomnia-in-children-and-adolescents-aged-10-to-18-years/
  8. https://clinicaltrials.gov/study/NCT05632393
  9. https://clinicaltrials.gov/study/NCT06326723