In the US, QUVIVIQ™ (daridorexant) CIV 25 mg and 50 mg tablets are indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1
QUVIVIQ becomes Idorsia’s first commercial product in the United States, now available to help American adults who suffer from insomnia
Allschwil, Switzerland & Radnor, PA, US– May2, 2022 Idorsia Ltd (SIX: IDIA) & Idorsia Pharmaceuticals, US Inc. today announced that QUVIVIQ™ (daridorexant) CIV 25 mg and 50 mg tablets are now commercially available for adult patients with insomnia, which is characterized by trouble with falling or staying asleep.
Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia. Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.4 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, substance abuse and dementia.5,6,7
QUVIVIQ is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness in insomnia.3 QUVIVIQ is recommended once per night, taken orally within 30 minutes before going to bed, with at least seven hours remaining prior to planned awakening.
Patricia Torr, President and General Manager of Idorsia US, commented: “After years dedicated to researching the science of sleep and the orexin system, today is a momentous milestone for Idorsia, as the company’s first product in the U.S. is now available to patients.”
About QUVIVIQ QUVIVIQ is a prescription medicine for adults who have trouble falling asleep or staying asleep (insomnia).
Important Safety Information Do nottake QUVIVIQ if you fall asleep often at unexpected times (narcolepsy). QUVIVIQ may cause serious side effects, including:
Decreased awareness and alertness. The morning after you take QUVIVIQ, your ability to drive safely and think clearly may be decreased. You may also have sleepiness during the day.
Do not take more QUVIVIQ than prescribed.
Do not take QUVIVIQ unless you are able to stay in bed for at least 7 hours before you must be active again.
Take QUVIVIQ at night within 30 minutes before going to bed.
QUVIVIQ is a federally controlled substance because it can be abused or lead to dependence. Before taking QUVIVIQ, tell your healthcare provider about all of your medical conditions, including if you:
have a history of depression, mental illness, or suicidal thoughts or actions; drug or alcohol abuse or addiction; a sudden onset of muscle weakness (cataplexy); daytime sleepiness
have lung or breathing problems, including sleep apnea
have liver problems
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Taking QUVIVIQ with certain medicines can cause serious side effects. QUVIVIQ may affect the way other medicines work and other medicines may affect the way QUVIVIQ works.
Do not take QUVIVIQ with other medicines that can make you sleepy unless instructed by your healthcare provider.
What should I avoid while taking QUVIVIQ?
Do not drink alcohol while taking QUVIVIQ. It can increase the effects of alcohol, which can be dangerous.
Do not drive, operate heavy machinery, do anything dangerous, or do other activities that require clear thinking if you do not feel fully awake, or you have taken QUVIVIQ and have less than a full night of sleep (at least 7 hours), or if you have taken more QUVIVIQ than prescribed.
QUVIVIQ may cause other serious side effects, including:
Worsening depression and suicidal thoughts. Call your healthcare provider right away if you have any worsening depression or thoughts of suicide or dying.
Temporary inability to move or talk (sleep paralysis) for up to several minutes, or hallucinations while you are going to sleep or waking up.
Complex sleep behaviors such as sleep-walking, sleep-driving, preparing and eating food, making phone calls, having sex or doing other activities while not fully awake that you may not remember the next morning. Stop taking QUVIVIQ and call your healthcare provider right away if you experience a complex sleep behavior.
The most common side effects of QUVIVIQ are headache and sleepiness.
These are not the only side effects of QUVIVIQ. Call your doctor for advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Notes to the editor
About Insomnia According to the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®), insomnia is defined as a combination of difficulty obtaining sufficient sleep and dissatisfaction with sleep combined with a significant negative impact on daytime functioning. Chronic insomnia is defined as difficulty initiating and/or maintaining sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.
Insomnia is a condition of overactive brain activity during sleep, and studies have shown that areas of the brain associated with wakefulness remain more active during sleep in patients with insomnia.
Insomnia is the most common sleep disorder, affecting more than 25 million adults in the US.2 Poor quality or insufficient sleep can affect many aspects of the daily lives of people with trouble sleeping including the ability to concentrate, mood and energy levels.4 In the long-term, insomnia is associated with numerous serious health conditions, such as psychiatric disorders, cardiovascular disease, type 2 diabetes, substance abuse and dementia.5,6,7
References
QUVIVIQ Prescribing Information. Idorsia Pharmaceuticals US Inc. Jan/2022
Bhaskar S, Hemavathy D, Prasad S. Prevalence of chronic insomnia in adult patients and its correlation with medical comorbidities. J Family Med Prim Care. 2016;5(4):780-784. doi:10.4103/2249-4863.201153.
Mignot E, et al. Lancet Neurol. 2022; 21: 125–39
Roth T. Insomnia: Definition, prevalence, etiology, and consequences. J. Clin. Sleep Med. 2007;15((Suppl. S5)):S7–S10. doi: 10.5664/jcsm.26929.
Olfson M, Wall M, Liu SM, Morin CM, Blanco C. Insomnia and Impaired Quality of Life in the United States. J Clin Psychiatry. 2018 Sep 11;79(5):17m12020. doi: 10.4088/JCP.17m12020.
Doghramji K. The epidemiology and diagnosis of insomnia. Am J Manag Care. 2006 May;12(8 Suppl): S214-20. PMID: 16686591.
de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older adults: Systematic review and meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi: 10.1016/j.jpsychires.2016.02.021. Epub 2016 Mar 8. PMID: 27017287.
About Idorsia US Idorsia U.S., an affiliate of Idorsia, is reaching out for more – we have more ideas, we see more opportunities, and we want to help more patients. To achieve this, we will help develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. With commercial operations based outside of Philadelphia, PA, one of densest communities of life sciences talent in the world, we are helping to realize the company’s ambition of bringing innovative medicines from bench to bedside. Our goal is to build a commercial footprint that will deliver Idorsia’s deep pipeline of products from its R&D engine to the U.S. market – with the potential to change the lives of many patients.
About Idorsia Idorsia Ltd is reaching out for more – We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core.
Headquartered near Basel, Switzerland – a European biotech-hub – Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet – the ideal constellation to translate R&D efforts into business success.
Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,200 highly qualified specialists dedicated to realizing our ambitious targets.
For further information, please contact US Media Christopher Clark Senior Director, US Head of Communications Idorsia Pharmaceuticals US, 100 Matsonford Road, Radnor, PA 19087 +1 (215) 421 4887 christopher.clark@idorsia.com ∙ www.idorsia.us
Global Investors & Media Andrew C. Weiss Senior Vice President, Head of Investor Relations & Corporate Communications Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 investor.relations@idorsia.com ∙ media.relations@idorsia.com ∙ www.idorsia.com
The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
