Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for
the treatment of adults with insomnia
Ad hoc announcement pursuant to Art. 53 LR
Idorsia receives US FDA approval of QUVIVIQ (daridorexant) 25 and 50 mg for
the treatment of adults with insomnia The approval of QUVIVIQ™ – 25 & 50 mg –
is based on a robust Phase 3 clinical program that demonstrated significant
improvement versus placebo on objective measures of sleep onset and sleep
maintenance, as well as patient reported total sleep time Idorsia’s first
approved medicine is a new treatment option for the approximately 25 million
American adults living with insomnia 2 ,3 , 4
Allschwil, Switzerland – January 10 , 2022
Idorsia Ltd (SIX: IDIA) today announced that the US Food and Drug
Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for
the treatment of adult patients with insomnia, characterized by difficulties
with sleep onset and/or sleep maintenance 1 . The FDA approval of QUVIVIQ is
based on an extensive clinical program that included 1,854 adults with insomnia
at over 160 clinical trial sites across 18 countries. Insomnia, a serious
medical condition, is the most common sleep disorder in the US.
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, as opposed to treatments that generally sedate the brain.
During the Phase 3 clinical program, QUVIVIQ demonstrated significant
improvement versus placebo on objective measures of sleep onset and sleep
maintenance, and patient reported total sleep time. Consistent with the US
prescribing information, the 50 mg dose of QUVIVIQ, which was evaluated in one
of the two pivotal studies, demonstrated a significant reduction in patient
reported daytime sleepiness, using a validated instrument. The most common
adverse reactions (in at least 5% of patients and greater than placebo) were
headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and somnolence or fatigue
(placebo: 4%, 25 mg: 6%, 50 mg: 5%).
The FDA has recommended that QUVIVIQ be classified as a controlled substance
and it is anticipated to be available to patients in May 2022, following
scheduling by the US Drug Enforcement Administration.
Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented:
“After more than 20 years of research and a progressive understanding of the
role of orexin in sleep-wake balance and of the potential of orexin receptor
antagonism, we designed daridorexant to help address several issues people with
insomnia face. Daridorexant properties include a potent inhibition of both
orexin receptors, a rapid absorption for sleep onset, and a pharmacokinetic
profile such that around 80% of daridorexant has been eliminated after a night
of sleep to help minimize residual effects.”
Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at
Henry Ford Hospital, commented:
“As noted in the definition of insomnia, the disorder is not only a problem of
the night but affects a patient’s ability to function during the day. Although
the personal and societal burden of insomnia is well established, elevating the
impact insomnia has on both the night and day remains critical in addressing
patients’ needs. I am encouraged to see a new advanced treatment option for the
millions of adults struggling with insomnia.”
Patricia Torr, President and General Manager of Idorsia US added:
“I am extremely proud to be leading the US organization of such a
forward-thinking and patient-centric organization like Idorsia. With this first
FDA approval for our company, QUVIVIQ provides a new treatment option that can
help adults with insomnia get to sleep faster and stay asleep longer, which we
know plays an important role in how they feel the next day. It’s an incredibly
exciting time for us and I can’t wait to transform the treatment paradigm in
the US. We have a differentiated product, an amazing team, and an innovative
strategy, giving me absolute confidence that we can make QUVIVIQ a great
Guy Braunstein, MD and Head of Global Clinical Development of Idorsia,
“In our investigation of daridorexant we were able to demonstrate an
improvement on objective sleep parameters, as well as improvement in
patient-reported outcomes. What is truly impressive, we have shown a dose
response in the efficacy of daridorexant, with no increase in the rate of
somnolence or fatigue with increasing doses.”
Phase 3 Clinical Program
The efficacy of QUVIVIQ was evaluated in two multicenter, randomized,
double-blind, placebo-controlled, parallel-group studies, Study 1 ( NCT03545191
) and Study 2 ( NCT03575104 ).
A total of 1854 patients with Diagnostic and Statistical Manual of Mental
Disorders, 5th edition (DSM-5 ® ) insomnia were randomized to receive QUVIVIQ
or placebo once daily, in the evening, for 3 months. Study 1 randomized 930
subjects to QUVIVIQ 50 mg (N = 310), 25 mg (N = 310) or placebo (N = 310).
Study 2 randomized 924 subjects to QUVIVIQ 25 mg (N = 309), 10 mg (N = 307), or
placebo (N = 308). The 10 mg dose is not an approved dose.
At the end of the 3-month treatment period, both studies included a 7-day
placebo run-out period, after which patients could enter a 9-month,
double-blind, placebo-controlled extension study (Study 3, NCT03679884 ). A
total of 600 subjects were treated for at least 6 months of cumulative
treatment, including 373 treated for at least 12 months.
Primary efficacy endpoints for both studies were the change from baseline to
Month 1 and Month 3 in Latency to Persistent Sleep (LPS) and Wake After Sleep
Onset (WASO), measured objectively by polysomnography in a sleep laboratory.
LPS is a measure of sleep induction and WASO is a measure of sleep maintenance.
Secondary endpoints included in the statistical testing hierarchy with Type I
error control were patient-reported Total Sleep Time (sTST), evaluated every
morning at home using a validated Sleep Diary Questionnaire (SDQ).
In Study 1, doses of 25 and 50 mg QUVIVIQ showed a statistically significant
improvement vs placebo on polysomnography (LPS, WASO) and self-reported total
sleep (sTST), at Month 1 and Month 3.
In Study 2, QUVIVIQ 25 mg showed a statistically significant improvement vs
placebo on WASO and sTST at Month 1 and Month 3. QUVIVIQ 10 mg did not show a
statistically significant improvement on LPS, WASO, or sTST at Month 1 or Month
The efficacy of QUVIVIQ was similar across subgroups based on age, sex, race,
The 50 mg dose of QUVIVIQ, which was evaluated in one of the two pivotal
studies, also demonstrated significant reduction in daytime sleepiness compared
to placebo, as measured by the sleepiness domain score from the Insomnia
Daytime Symptoms and Impacts Questionnaire (IDSIQ) 7 at month 1 and month 3
(key secondary endpoint). Results on this endpoint for the 25mg dose did not
reach statistical significance in either study at both timepoints.
The most common reported adverse reactions (in at least 5% of patients and
greater than placebo) were headache (placebo: 5%, 25 mg: 6%, 50 mg: 7%,) and
somnolence or fatigue (placebo: 4%, 25 mg: 6%, 50 mg: 5%).
For more information see the Full Prescribing Information (PI and Medication
Important Safety Information
QUVIVIQ is a prescription medicine for adults who have trouble falling asleep
or staying asleep (insomnia).
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
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
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. 3 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. 4 ,5,6
About Dr. Thomas Roth, PhD
Dr. Roth has been the Director of the Sleep Disorders and Research Center at
Henry Ford Hospital in Detroit, since 1978. Dr. Roth is also a Professor in the
Department of Psychiatry at Wayne State University, School of Medicine in
Detroit, Michigan, and serves as a Clinical Professor in the Department of
Psychiatry at the University of Michigan, College of Medicine in Ann Arbor.
After serving as president of the Sleep Research Society, and the founding
president of the National Sleep Foundation (NSF), Dr. Roth became chairman of
the National Center on Sleep Disorders Research advisory board. In addition, he
was a member of the board of directors of the Associated Professional Sleep
Societies (APSS), chaired the Association's Scientific Program Committee and
the governing board of the World Federation of Sleep Research Societies.
Dr. Roth was instrumental in the formation of the Association of Sleep
Disorders Center (ASDC) and served as the organization's second president. He
is also the former Chairman of the World Health Organization's worldwide
project on sleep and health. In addition to authoring and co-authoring numerous
articles, Dr. Roth serves as past editor-in-chief of the journal Sleep. He
currently sits on the editorial boards of Sleep Reviews, Stress Medicine, and
Advances in Therapy and Human Psychopharmacology.
In 2002, Dr. Roth received the NSF's Lifetime Achievement Award for his
accomplishments and contributions to sleep science, sleep medicine and public
health. He received a Distinguished Research Award from the Sleep Research
Society as well as the Nathanial Kleitman Award from the Academy of Sleep
Medicine. Dr. Roth's contributions to the sleep field are expansive, ranging
from prolific research productivity and scholarship to multiple national
leadership positions, as well as the mentoring of many students and colleagues.
Dr. Roth serves as a consultant to Idorsia.
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. Ustinov Y,
Lichstein KL, Wal GS, Taylor DJ, Riedel BW, Bush AJ. Association between report
of insomnia and daytime functioning. Sleep Med. 2010 Jan;11(1):65-8. doi:
10.1016/j.sleep.2009.07.009. Epub 2009 Sep 23. 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. Hudgens S,
Phillips-Beyer A, Newton L, Seboek Kinter D, Benes H. Development and
validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ).
Patient. 2020;14(2): 249-268. https://doi. org/ 10. 1007/ s40271- 020- 00474-z
About Idorsia US
Idorsia US, 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 US market – with the potential to change the lives of many patients.
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
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 1’000 highly qualified specialists dedicated to realizing our
For further information, please contact
Senior Director, US Head of Communications
Idorsia Pharmaceuticals US, 100 Matsonford Road, Radnor, PA 19087
+1 (215) 421 4887
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
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