Regulatory review is also ongoing in Canada and Switzerland and is planned for the United Kingdom. Daridorexant was originated by Actelion Pharmaceuticals and was further developed by Idorsia. Society and culture
Legal status
Daridorexant is a schedule IV controlled substance under the Controlled Substances Act in the United States.Daridorexant (Quviviq) was approved for medical use in the European Union in April 2022. References
Further reading
"Application Number: 214985Orig1s000. Integrated Review. Daridorexant (Quviviq) for Insomnia" (PDF). Center for Drug Evaluation and Research (Food and Drug Administration). 2022. Archived from the original (PDF) on 22 April 2022. "Quviviq (Daridorexant) Assessment Report. Procedure No. EMEA/H/C/005634/0000" (PDF). Committee for Medicinal Products for Human Use (European Medicines Agency). 24 February 2022. External links
"Daridorexant". Drug Information Portal. U.S. National Library of Medicine.
The endometrial transformation dosage of micronized NETA per cycle is 12 to 14 mg, whereas that for non-micronized NETA is 30 to 60 mg.NETA metabolizes into ethinylestradiol at a rate of 0.20 to 0.33% across a dose range of 10 to 40 mg. Peak levels of ethinylestradiol with a 10, 20, or 40 mg dose of NETA were 58, 178, and 231 pg/mL, respectively. For comparison, a 30 to 40 μg dose of oral ethinylestradiol typically results in a peak ethinylestradiol level of 100 to 135 pg/mL. As such, in terms of ethinylestradiol exposure, 10 to 20 mg NETA may be equivalent to 20 to 30 μg ethinylestradiol and 40 mg NETA may be similar to 50 μg ethinylestradiol. In another study however, 5 mg NETA produced an equivalent of 28 μg ethinylestradiol (0.7% conversion rate) and 10 mg NETA produced an equivalent of 62 μg ethinylestradiol (1.0% conversion rate). Due to its estrogenic activity via ethinylestradiol, high doses of NETA have been proposed for add-back in the treatment of endometriosis without estrogen supplementation. Generation of ethinylestradiol with high doses of NETA may increase the risk of venous thromboembolism but may also decrease menstrual bleeding relative to progestogen exposure alone.NETA has antigonadotropic effects via its progestogenic activity and can dose-dependently suppress gonadotropin and sex hormone levels in women and men. The ovulation-inhibiting dose of NETA is about 0.5 mg/day in women.