A New Revolutionary Insomnia Drug Pends FDA Approval
written by/ April 20, 2021
This January, the biopharmaceutical company Idorsia Pharmaceuticals Ltd. submitted an application to the Food and Drug Administration (FDA) for the assessment of Daridorexant — the company’s insomnia treatment drug.
Daridorexant is an absolute novelty in the market because of its effective but short-term action. Specifically, it leaves the patient’s system quickly, enabling them to function without the inconvenient next-day drowsiness caused by other sleep medication.
While the traditional insomnia medication is usually a Central Nerve System depressor, Daridorexant is a so-called dual orexin receptor antagonist.
This means that it temporarily deactivates the overactive wakefulness by disabling orexin neuropeptides’ action — substances responsible for promoting alertness.
Today, daytime sleepiness and withdrawal effects are the main reasons why insomniacs reach for the best natural sleep aids instead of prescription pills. But this will change if Daridorexant finds its place on the shelves in pharmacies across the US.
Namely, during clinical studies, this revolutionary drug showed none of these residual effects.
The side effects, the efficacy, and safety of Daridorexant were tested in two clinical trials and a developmental program — all part of the exhaustive New Drug Application (NDA) dossier submitted to the FDA.
The clinical studies’ results, read publicly in April 2020, revealed that the drug dramatically improves sleep onset, sleep maintenance, and subjective sleep parameters.
Plus, both studies confirm this treatment’s safety for those over 65 years old which is the most insomnia-affected age group.
Now it is up to the FDA to evaluate this potential game-changer for insomniacs and approve it. If the decision is a positive one, patients will be able to benefit from Daridorexant in the first half of 2022, at the earliest.