Idorsia Positive Data
- A recent study highlights a potential breakthrough for individuals grappling with both insomnia and nocturia, the frequent need to urinate during the night.
- Insomnia and nocturia frequently enough occur together, particularly in older adults.
- The Phase 4 study focused on daridorexant, a dual orexin receptor antagonist (DORA), and its impact on patients with comorbid insomnia and nocturia.
Innovative Treatment Shows Promise for Insomnia and Nocturia
Table of Contents
A recent study highlights a potential breakthrough for individuals grappling with both insomnia and nocturia, the frequent need to urinate during the night. The research indicates that addressing both conditions simultaneously can significantly improve sleep quality, daytime functioning, and overall quality of life.
The Comorbidity of Insomnia and Nocturia
Insomnia and nocturia frequently enough occur together, particularly in older adults. This combination can lead to fragmented sleep,impacting daily activities and diminishing overall well-being. The study emphasizes the importance of recognizing and treating these conditions in a coordinated manner.
daridorexant: A Potential Solution
The Phase 4 study focused on daridorexant, a dual orexin receptor antagonist (DORA), and its impact on patients with comorbid insomnia and nocturia. The results suggest that daridorexant not only improves sleep but also reduces the frequency of nighttime urination.
One of the coordinating investigators, commented:
in patients needing to frequently visit the bathroom during the night, insomnia is very common and a significant burden for patients. The results that have been generated in this study are remarkable. Not only have we seen consistent efficacy after a short treatment period and across the insomnia measures – including increasing total sleep time and an remarkable effect on insomnia severity – but also there was a great effect on their nocturia. What’s more, patients also experienced improved next-day functioning and consequently reported significantly higher satisfaction after treatment with daridorexant versus placebo. I hope that the ability to affect both comorbidities will encourage a more joined-up thinking for specialists of both conditions to adequately treat these patients.
Another investigator in the study, emphasized the impact of severe nocturia on patients’ lives:
Many peopel visit the toilet during the night, go straight back to sleep and think nothing more of it. For these people, it is indeed difficult to understand the impact that nocturia can have. The patients enrolled in this study are waking 3, 4 and sometiems 5 or more times during the night to use the toilet, so quite severe nocturia symptoms. When combined with insomnia, the patients are badly affected by the disruption, with many not able to function well the next day. The results in the study show that the patients are able to sleep longer before the first visit to the toilet and need to go fewer times, these are certainly clinically meaningful results.
Study Design and key Findings
The study involved 60 participants, both men and women aged 55 or older, with both insomnia and nocturia. The participants underwent two four-week treatment periods, separated by a washout period. The study was designed as a multi-national, multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over trial.
Significant Improvements observed
The study revealed that daridorexant 50 mg led to:
- Significant betterment in subjective total sleep time (sTST).
- reduction in Insomnia severity Index (ISI) scores.
- Improved daytime functioning, as measured by the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
- Reduced number of nocturnal voids.
- Increased time to first void.
| Measure | Daridorexant 50mg | Placebo |
|---|---|---|
| Improvement in sTST | Significant | Less Significant |
| Reduction in ISI Score | ≥6 units | less than ≥6 units |
| Reduction in Nocturnal Voids | Yes | No |
Safety and Tolerability
Daridorexant 50 mg was found to be safe and well-tolerated, aligning with previous Phase 3 studies. Notably, there were no reports of urinary incontinence or falls among patients treated with daridorexant.
The Chief Medical Officer & Head of Global Medical Affairs,commented on the study’s implications:
We already have incredibly strong and robust data demonstrating that daridorexant is an effective treatment of insomnia disorder with an optimal duration of action and a well-documented safety profile. Nonetheless, I am very impressed with the study results becuase hear we see that daridorexant has a positive effect on both insomnia and nocturia endpoints. After a short treatment period, patients reported a significant improvement on the quality of their nights’ sleep and importantly, also on their days. I am very proud that Idorsia is leading the way in building evidence on the burden of insomnia and furthering the science of sleep.
World Sleep Day and the Importance of Sleep Health
The declaration of these study results coincides with World Sleep Day, an annual event dedicated to raising awareness about the importance of sleep. Sleep is recognized as one of the three pillars of health, alongside diet and exercise, and is crucial for physical, mental, and social well-being.
Sleep disorders, such as chronic insomnia, affect a significant portion of the adult population. Chronic insomnia is defined as experiencing difficulty falling or staying asleep for at least three days a week for at least three months,significantly impacting daytime activities.
the President of Europe and Canada region, emphasized the company’s commitment to sleep health:
All of us at Idorsia are proud supporters of World Sleep Day, and we are united with the World Sleep Society in the call to action to make sleep health a priority. We support patients, advocates and the medical community in elevating the conversation around sleep and emphasizing the significant, and often hidden, impact chronic sleep disorders have on individuals and society.
Understanding insomnia and Nocturia
Insomnia involves dissatisfaction with sleep, including difficulty initiating or maintaining sleep, occurring at least three nights per week for at least three months. It is often linked to overactive wake signaling in the brain.
nocturia is defined as waking during the night to urinate, considered clinically relevant if it occurs at least twice per night. It disrupts sleep and can lead to difficulties returning to sleep.
The Impact of Nocturia on Sleep Quality
Nocturia is a predictor of insomnia, with an increased number of voids per night associated with worsened sleep quality and overall quality of life. Addressing both insomnia and nocturia is essential for improving patients’ well-being.
Innovative Treatment for Insomnia and Nocturia: Q&A
This article addresses common questions about a new study exploring a potential treatment for individuals suffering from both insomnia and nocturia.
Key Questions About Daridorexant for Insomnia and Nocturia
What is the link between insomnia and nocturia?
Insomnia and nocturia frequently co-occur. This combination results in fragmented sleep, negatively impacting daily activities and overall well-being, particularly in older adults.It’s crucial to address both conditions in a coordinated manner.
What is daridorexant?
Daridorexant is a dual orexin receptor antagonist (DORA). A recent Phase 4 study explored its impact on patients experiencing both insomnia and nocturia. The study suggests that daridorexant improves sleep and reduces the frequency of nighttime urination.
how does daridorexant work?
Insomnia is frequently enough linked to overactive wake signaling in the brain.Daridorexant, as a dual orexin receptor antagonist, works by blocking the action of orexin, a neurotransmitter involved in promoting wakefulness. This helps reduce overactive wake signaling, facilitating sleep.
Who led the study on daridorexant?
The study enrolled 60 participants, including adult men and women aged 55 or older, all diagnosed with both insomnia and nocturia. The study was designed as a multi-national, multi-center, double-blind, randomized, placebo-controlled, 2-way cross-over trial.
Was daridorexant effective in treating insomnia and nocturia?
yes, the study revealed that daridorexant 50 mg led to:
Significant betterment in subjective total sleep time (sTST).
reduction in Insomnia severity Index (ISI) scores.
Improved daytime functioning, as measured by the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
Reduced number of nocturnal voids.
* Increased time to first void.
Is daridorexant safe?
Researchers found Daridorexant 50 mg to be safe and well-tolerated,with no reports of urinary incontinence or falls among patients. These results align with the findings of previous Phase 3 studies.
Deeper Understanding of Insomnia and Nocturia
What is insomnia?
Insomnia involves dissatisfaction with sleep, including difficulty initiating or maintaining sleep. It occurs at least three nights per week for at least three months and is often linked to overactive wake signaling in the brain. Chronic insomnia is defined as experiencing difficulty falling or staying asleep for at least three days a week for at least three months,substantially impacting daytime activities.
What is nocturia?
nocturia is defined as waking during the night to urinate, generally considered clinically relevant if it occurs at least twice per night. It disrupts sleep and can lead to difficulties returning to sleep. It is a predictor of insomnia, with an increased number of voids per night associated with worsened sleep quality and overall quality of life.
How is nocturia diagnosed?
nocturia is typically diagnosed based on a patient’s voiding diary,where they record the frequency and timing of urination. A healthcare professional will assess the diary, along with other factors, to determine the cause and severity of the nocturia.
What is World Sleep Day?
World Sleep Day is an annual event dedicated to raising awareness about the importance of sleep. Sleep is recognized as one of the three pillars of health, alongside diet and exercise, and is crucial for physical, mental, and social well-being.
Daridorexant vs. Placebo: A Comparison
| Measure | Daridorexant 50mg | Placebo |
| :—————————– | :—————- | :————— |
| Improvement in sTST | significant | Less significant |
| Reduction in ISI Score | ≥6 units | less than ≥6 units |
| Reduction in Nocturnal Voids | Yes | No |