Idorsia’s new treatment QUVIVIQ (daridorexant) is now available in the US for
adults living with insomnia 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 maintenance 1
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 – M ay 2 , 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.”
To learn more about QUVIVIQ, visit QUVIVIQ.com . For more information see the
Full Prescribing Information (PI and Medication Guide).
About QUVIVIQ
QUVIVIQ is a prescription medicine for adults who have trouble falling asleep
or staying asleep (insomnia).
Important Safety Information
Do not take 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.
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