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Prescription, Nonprescription and Orphan Drugs01:02

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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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Direct-acting cholinergic agonists have many therapeutic uses in various medical fields. Choline esters, including acetylcholine, have limited clinical utility due to their non-selectivity and short duration of action. Still, acetylcholine and carbachol are applied topically during ophthalmologic surgery to induce miosis. Pilocarpine, a muscarinic and ganglionic stimulator, effectively treats open-angle glaucoma and alleviates xerostomia and dry mouth caused by radiotherapy or Sjögren...
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The renin-angiotensin-aldosterone system (RAAS) is an intricate physiological pathway involving numerous enzymes and hormones, including renin, angiotensin-converting enzyme (ACE), angiotensin I and II, and aldosterone. Imbalances within this system increase the production of angiotensin II and aldosterone. Increased angiotensin II levels promote vasoconstriction and blood pressure elevation. Concurrently, higher aldosterone levels stimulate sodium and water reabsorption in the kidneys,...
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Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
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Updated: Sep 30, 2025

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Daridorexant: First Approval.

Anthony Markham1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

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|March 17, 2022
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Summary
This summary is machine-generated.

Daridorexant (Quviviq™) is a new dual orexin receptor antagonist approved for treating insomnia. It targets sleep onset and maintenance issues, aiming to improve daytime function by minimizing residual effects.

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Area of Science:

  • Pharmacology
  • Sleep Medicine
  • Drug Development

Background:

  • Insomnia is a prevalent sleep disorder affecting sleep onset and maintenance.
  • Orexin receptor antagonists represent a novel therapeutic approach for insomnia.
  • Daridorexant targets both orexin 1 and orexin 2 receptors.

Purpose of the Study:

  • To summarize the development milestones of daridorexant.
  • To highlight the clinical trials leading to its approval for insomnia.
  • To detail its mechanism as a dual orexin receptor antagonist.

Main Methods:

  • Review of preclinical and clinical development data for daridorexant.
  • Analysis of pivotal Phase III trial results.
  • Pharmacokinetic and pharmacodynamic assessments.

Main Results:

  • Daridorexant demonstrated efficacy in Phase III trials for sleep onset and maintenance insomnia.
  • The drug has an approximate 8-hour effect duration with a half-life minimizing daytime impairment.
  • Regulatory approval in the USA was based on robust clinical trial evidence.

Conclusions:

  • Daridorexant (Quviviq™) is a newly approved treatment for adult insomnia.
  • Its dual orexin receptor antagonism offers a targeted approach to sleep regulation.
  • Development focused on balancing efficacy with minimized residual daytime effects.