In January 2022, a new medication was FDA approved for medical use in the United States. The medication is called “Dariodorexant”, which is used to help people suffering from insomnia. However, since this medication is so new, you may not be entirely educated on its clinical testing, its use of it, and many other important pieces of information. Therefore, this article will be highlighting all the useful and crucial aspects of this drug, that any potential user may need to be aware of.
What is Daridorexant?
“Daridorexant”, which will be sold under the brand name “Quviviq”, is a dual orexin receptor antagonist (DORA). An orexin receptor antagonist is considered to be a drug that inhibits the effect of orexin, by acting as a receptor antagonist to one or both of your orexin receptors, OX1 and OX2.
“Orexin”, which is also known as hypocretin, is a neuropeptide that regulates our bodily functions such as appetite, arousal, and wakefulness. Daridorexant was originated by Actelion Pharmaceuticals and is under development by Idorsia Pharmaceuticals.
The medication works in a way that blocks the binding of wake-promoting neuropeptide orexins, which will alleviate the overactive wakefulness in the mind and body. This will help folks with major issues in both falling asleep and remaining asleep throughout the night. Because of this, this medication also aims to help folks live a healthier daytime lifestyle – free of being overtired or continuously exhausted.
Tested Before Being Approved
Like with any new medication or drug being brought to market for consumption, Daridorexant went through an abundance of testing and scrutiny before becoming FDA approved. The approval rating was based on Phase 3 clinical trials, involving nearly 2000 adults with insomnia. People from 18 different countries took part in this trial, at over 160 clinical sites around the world.
These individuals were completely randomized, where some would routinely receive Daridorexant, while others were given a placebo. This occurred on a daily basis, in the evening, for three consecutive months.
The first study in the clinical trial randomized over 900 individuals to either a 50mg or 25mg dose of Daridorexant, or a placebo. While the second study used the same number of individuals but lessened the dose of Daridorexant to 25mg or 10mg.
At the end of the 3-month trial period, both studies concluded with a 7-day placebo run-out, from which individuals were able to opt into entering another 9-month, placebo-controlled extension study, which was considered to be double-blind. Of the total participants, 600 individuals chose to receive at least 6 months of cumulative treatment for the study, of which, over half continued treatment for a year.
Results of Clinical Trials
As a result of the clinical trials, researchers were able to pinpoint the effectiveness and adverse events that occurred. The primary efficacy endpoints in the studies were the notable change from baseline, to month one and month three in “Latency to Persistent Sleep”. This is the overall measure of sleep induction or essentially, the deliberate effort to bring on sleep by various techniques, or in this case, medication.
The other crucial primary endpoint was the study of “Wake After Sleep Onset” (WASO), which is the measurement of sleep maintenance. This was measured objectively and similarly for every participant, by polysomnography in the designated sleep laboratories.
The secondary endpoints of this trial included in the statistical testing hierarchy were patient-reported “Total Sleep Time” (TST). This was to be evaluated every morning at home, using a validated sleep diary and questionnaire.
It was found that within the first study, doses of both 25mg and 50mg, showed a significant statistical improvement against the placebo – especially at both months one and three. Whereas in the second study, the 25mg dose showed another significant statistical improvement on Wake After Sleep Onset and Total Sleep Time. This was again, especially true in months one and 3, compared to that of the mere placebo.
Unfortunately, the 10mg dose did not show any forms of significant improvements on the test subjects, and because of this, this specific dosage was not formally approved by the FDA.
In terms of the 50mg dose, it also demonstrated a very high reduction in daytime sleepiness, compared to that of the placebo. This was measured by the “sleepiness domain score” from the Insomnia Daytime Symptoms and Impacts Questionnaire that all participants had to fill out, during the month one and three conclusive stages. However, results in accordance with this endpoint for the 25mg dose did not reach what would be considered as statistical significance, in either of the studies at both timepoints.
Adverse Events
Like many medications and medical trials, there were some adverse events that occurred to some of the participating insomnia patients. The most common adverse events that were found were:
- Headaches
- Somnolence
- Fatigue
However, a statement of the company was released, that claims that the drug may also cause other, more serious side effects. Some of these may include:
- Sleep Paralysis
- Hallucinations
- Worsening Depression (if preexisting)
- Suicidal Thoughts
- “Complex Sleep Behaviors” (not remembered in the morning)
Is Daridorexant Safe to Use?
In short, yes, it is safe. With the American FDA approval, Daridorexant is now considered a proper medicinal option for folks suffering from insomnia. Both the 25mg and 50mg doses have been proven to assist folks with sleep onset or additional sleep maintenance.
As long as the patient with insomnia uses this medication appropriately, following necessary guidelines or dosage information, this should be a medication that helps improve both their sleep and daytime life.
It is important to note that Daridorexant is considered to be a controlled substance, under the recommendation of the FDA. This means, that in order to receive and begin taking this medication, one will have to first get a prescription from a medical professional.
Conclusion
Although Daridorexant has yet to hit the market, with its new approval, it is expected to begin hitting the United States market and pharmacy shelves by May 2022. For additional information on this medication, its effectiveness, insomnia, and clinical trials, we highly recommend watching the following video.
