Healthcare Professional Portal

Return to portal
PI & AE

For patients with chronic insomnia1

Night-time
sleep

Daytime
functioning

QUVIVIQ™ is indicated for
the treatment of adult patients with insomnia
characterised by symptoms present for at
least 3 months and considerable impact
on daytime functioning.1

Prescribing information can be accessed using the PI button at the side.
This information is intended for healthcare professionals.

Adverse events must be reported. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store. Adverse events should also be reported to ds.safety.uk@idorsia.com.

NICE recommended for chronic insomnia12

Discover how QUVIVIQ™ 50 mg could make a difference to your patients with chronic insomnia:1,2

A different mode of action

Find out how QUVIVIQ™ works differently to sedating hypnotics1,3

Night-time efficacy

Discover how your patients could fall asleep faster and stay asleep longer vs placebo2

Daytime efficacy

Find out how QUVIVIQ™ works differently to sedating hypnotics1,3

No evidence of abuse in clinical trials

Discover how QUVIVIQ™
is not associated with withdrawal symptoms or rebound insomnia upon discontinuation*1,2

Safety
profile

See the safety profile of QUVIVIQ™ vs placebo with continuous nightly treatment2

Nightly
dosing

Review the recommended dose and find out more about how your patients can get the most out of their treatment1

Treatment duration should be as short as possible.
Treatment must be assessed within 3 months and periodically thereafter.1

* No evidence of physical dependency, withdrawal symptoms or rebound insomnia was observed after discontinuation of QUVIVIQ™ with up to 12 months of continuous treatment in clinical trials.1,2

Want to stay up to date with the latest developments in chronic insomnia?

Register now

At night, patients with chronic insomnia may be in a state of hyperarousal4

In chronic insomnia, research suggests that wake-promoting regions of the brain remain overactive at night (hyperarousal).4,5

 

Orexin is a neurotransmitter that promotes wakefulness and provides a specific target for intervention.3

Hyperarousal

Figure adapted from Saper et al, 2005.

Disclaimer: this image is a representation of this state in the brain and the principal areas involved – it is not intended to be fully comprehensive of all brain areas involved.

QUVIVIQ™ works differently to sedating hypnotics by blocking the action of orexin, reducing wake-drive and allowing restorative sleep to occur without altering the proportion of sleep stages.1,3,9

QUVIVIQ™ mechanism of action

Figure adapted from Saper et al, 2005.

Disclaimer: this image is a representation of this state in the brain and the principal areas involved – it is not intended to be fully comprehensive of all brain areas involved.

Find out more about hyperarousal and the night and day impact of chronic insomnia at RethinkInsomnia.co.uk

Learn more
Learn more

The QUVIVIQ™ trial programme was designed to assess both the night and day impact of chronic insomnia2,10

The safety and efficacy of QUVIVIQ™ was evaluated in two multicentre,
randomised, double-blind, parallel-group, placebo-controlled Phase 3 studies2

  • Select inclusion criteria:

  • Age ≥18 years

  • Chronic insomnia (insomnia disorder) of moderate or severe intensity according to DSM-5 criteria (Insomnia Severity Index score ≥15)
  • Select exclusion criteria:

  • Any other condition causing insomnia

  • Ongoing cognitive behavioural therapy, shift work, travel over time zones

  • Treatment with central nervous system-active drugs for a minimum of 14 days prior to visit*10

Key primary endpoints:

Change from baseline to Month 1 and 3
measured by polysomnography in:

  • Latency to persistent sleep (LPS)
  • Wake after sleep onset (WASO)

Key secondary endpoints:

Change from baseline at Months 1 and 3 for:

  • Patient-reported change in total sleep time (sTST)
  • Patient reported change in score for sleepiness domain of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)

After completion of 3 months of study treatment, participants
were able to join a 9-month placebo-controlled extension trial

* Including over the counter medication and herbal medicines.10
† A 25 mg dose is recommended for patients with moderate hepatic impairment, or those using moderate CYP3A4 inhibitors (e.g. erythromycin, ciprofloxacin, cyclosporine).1
 ‡ A 10 mg dose is not licensed for use, and therefore not presented.1

Help your patients have better night-time sleep and better daytime functioning vs placebo with
QUVIVIQ™ 50 mg2

Night-time
sleep

Daytime
functionning

Night-time sleep

Night-time sleep

Study design
Study design

Primary endpoint:2

Latency to persistent sleep (LPS) – a measure of sleep induction
LPS values are the mean of the polysomnography recordings recorded over 2 consecutive nights during the 3 month double-blind treatment period.2

LPS Study 1:

Objective change from baseline in LPS to Months 1 and 3 for QUVIVIQ™ vs placebo1,2

With QUVIVIQ™ 50 mg, patients fell asleep significantly faster vs placebo (p<0.0001)2

LPS Study 2:

Objective change from baseline in LPS to Months 1 and 3 for QUVIVIQ™ vs placebo1,2

Primary endpoint:2

Wake time after sleep onset (WASO) – a measure of sleep maintenance
WASO values are the mean of the polysomnography recordings recorded over 2 consecutive nights during the 3 month double-blind treatment period.2

WASO Study 1:

Objective change from baseline in WASO to Months 1 and 3 for QUVIVIQ™ vs placebo1,2

With QUVIVIQ™ 50 mg, patients spent significantly less time awake after sleep onset vs placebo (p<0.0001)

WASO Study 2:

Objective change from baseline in WASO to Months 1 and 3 for QUVIVIQ™ vs placebo1,2

With QUVIVIQ™ 25 mg, patients spent significantly less time awakeafter sleep onset vs placebo2

Secondary endpoint:2

Self-reported total sleep time (sTST)
sTST was evaluated each morning by patients using a sleep diary questionnaire.2

sTST Study 1:

Change from baseline in sTST to Months 1 and 3 for QUVIVIQ™ vs placebo1,2

With QUVIVIQ™ 50 mg, patients had significantly more time asleep vs placebo (p<0.0001)2

sTST Study 2:

Change from baseline in sTST to Months 1 and 3 for QUVIVIQ™ vs placebo1,2

With QUVIVIQ™ 25 mg, patients had significantly more time asleep vs placebo2

Upon discontinuation of QUVIVIQ™, with up to 12 months of continuous treatment in clinical trials, there was:

No evidence of abuse or withdrawal symptoms, indicating no physical dependence1

No sign of rebound insomnia
in clinical studies1

Treatment duration should be as short as possible. Treatment must be assessed within 3 months and periodically thereafter.1

Side effect profile of QUVIVIQ™1,2

Study design
Study design
graph_ae_01
graph_ae_03
graph_ae_02
ae-mob-1-2-1
ae-mob-2-2-1
ae-mob-3-2-1

The safety profile of QUVIVIQ™ when taken nightly has been demonstrated over 12 months of continuous treatment1

Somnolence was reported in 3% and 2% of subjects treated with QUVIVIQ™ 25 mg and 50 mg, respectively, compared to 2% of subjects on placebo.1 Sleep paralysis was reported in 0.5% and 0.3% subjects receiving QUVIVIQ™ 25 mg and 50 mg, respectively, compared to no reports for placebo.1 Hypnagogic and hypnopompic hallucinations were reported in 0.6% subjects receiving QUVIVIQ™ 25 mg compared to no cases with QUVIVIQ™ 50 mg or placebo.1


The majority of adverse reactions were mild to moderate in intensity. No evidence of a dose-relationship for the frequency or severity of adverse reactions was observed. The adverse reaction profile in elderly subjects was consistent with younger subjects.1


Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Adverse events should be reported. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. This can be accessed using the button at the side. Alternatively, search for MHRA Yellow Card in Google Play or Apple App Store.

Special warnings and precautions for use
Special warnings and precautions for use

Taking QUVIVIQ™1

QUVIVIQ™ is indicated for the treatment of adult patients with insomnia characterised by symptoms present for at least 3 months and considerable impact on daytime functioning.1

The recommended dose for adults is:

50 mg

once per night1

Pill not to actual size

The recommended dose for patients with moderate hepatic impairment or taking moderate CYP3A4 inhibitors is: 

25 mg

once per night1

What your patients will need to know:

The maximum daily dose of QUVIVIQ™ is 50 mg once per night.1

QUVIVIQ™ should be taken within 30 minutes before going to bed1

Time to sleep onset may be delayed if taken soon after a large meal1

Continue to practise good sleep hygiene

Learn more
Learn more

QUVIVIQ™ is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, narcolepsy and concomitant use with strong CYP3A4 inhibitors (e.g. itraconazole, clarithromycin, ritonavir).1

In the case of co-administration with CNS-depressant medicinal products, dose adjustments of QUVIVIQ™ and/or the other medicinal products may be required, based on clinical evaluation, due to potentially additive effects.1

Improvements from baseline, vs placebo, in sleep outcomes and daytime functioning were seen with consistent nightly dosing of QUVIVIQ™ 50 mg at Months 1 and 3.2

Help your patients with chronic insomnia have better night-time sleep and daytime functioning vs placebo1,2

With nightly QUVIVIQ™ 50 mg, you could help your patients have:1,2

Statistically significant improvements in LPS, WASO and sTST vs placebo1,2
Clinically meaningful reduction in daytime sleepiness from baseline vs placebo1,2
The reassurance of no evidence of physical dependence after discontinuation in clinical trials*1
Previous
Next

* No evidence of physical dependency, withdrawal symptoms or rebound insomnia was observed after discontinuation of QUVIVIQ™ with up to 12 months of continuous treatment in clinical trials.1,2

 

Discover which of your patients with chronic insomnia could benefit from better nights and days with QUVIVIQ™

Learn more
Learn more

Abbreviations

AE, adverse event; CI, confidence interval; CNS, central nervous system; DSM-5, Diagnostic Statistical Manual of Mental Disorders, Fifth Edition; FAQ, frequently asked question; FDA, Food and Drug Administration; IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LPS, latency to persistent sleep; LSM, least squares mean; MoA, mode of action; NICE, National Institute for Health and Care Excellence; PRO, patient-reported outcome; sTST, self-reported total sleep time; WASO, wake time after sleep onset.

AE, adverse event; CI, confidence interval; CNS, central nervous system; DSM-5, Diagnostic Statistical Manual of Mental Disorders, Fifth Edition; FAQ, frequently asked question; FDA, Food and Drug Administration; IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LPS, latency to persistent sleep; LSM, least squares mean; MoA, mode of action; PRO, patient-reported outcome; sTST, self-reported total sleep time; WASO, wake time after sleep onset.

Adverse events must be reported. Healthcare professionals are asked to report any suspected adverse reactions via www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store. Adverse events should also be reported to ds.safety.uk@idorsia.com.

This site is intended only for healthcare professionals resident in the United Kingdom.

References

  1. QUVIVIQ™ Idorsia Pharmaceuticals LTD, Summary of Product Characteristics. Last updated: August 2023.
  2. Mignot E, et al. Lancet Neurol. 2022. 21(2); 125–139.
  3. Roch C, et al. Psychopharmacology. 2021; 238(10): 2693–2708.
  4. Riemann D, et al. Sleep Med Rev. 2010; 14(1): 19–31.
  5. Nofzinger E, et al. Am J Psychiatry. 2004; 161: 2126–2129.
  6. Saper C, et al. Nature. 2005; 437(7063): 1257–1263.
  7. Janto K, et al. J Clin Sleep Med. 2018; 14(8): 1399–1408.
  8. Reimann D, et al. Lancet Neurol. 2015; 14: 547–558.
  9. Chaput JP, et al. Nat Sci Sleep. 2018; 10: 421–430.
  10. Mignot E, et al. Lancet Neurol. 2022. 21(2); 125–139. Supplementary Appendix.
  11. Hudgens S, et al. Patient. 2021; 14(2): 249–268.
  12. NICE. Daridorexant for treating long-term insomnia. Technology appraisal guidance [TA922] Available at: https://www.nice.org.uk/guidance/ta922. Last accessed October 2023.
  1. QUVIVIQ™ Idorsia Pharmaceuticals LTD, Summary of Product Characteristics. Last updated: March 2023.
  2. Mignot E, et al. Lancet Neurol. 2022. 21(2); 125–139.
  3. Roch C, et al. Psychopharmacology. 2021; 238(10): 2693–2708.
  4. Riemann D, et al. Sleep Med Rev. 2010; 14(1): 19–31.
  5. Nofzinger E, et al. Am J Psychiatry. 2004; 161: 2126–2129.
  6. Saper C, et al. Nature. 2005; 437(7063): 1257–1263.
  7. Janto K, et al. J Clin Sleep Med. 2018; 14(8): 1399–1408.
  8. Reimann D, et al. Lancet Neurol. 2015; 14: 547–558.
  9. Chaput JP, et al. Nat Sci Sleep. 2018; 10: 421–430.
  10. Mignot E, et al. Lancet Neurol. 2022. 21(2); 125–139. Supplementary Appendix.
  11. Hudgens S, et al. Patient. 2021; 14(2): 249–268.

UK-DA-00254 | Date of preparation: November 2023
Copyright © 2023 Idorsia Pharmaceuticals Ltd

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Ut elit tellus, luctus nec ullamcorper mattis, pulvinar dapibus leo.

Hyperarousal

Figure adapted from Saper, et al. 2005.

 

Disclaimer: this image is a representation of this state in the brain and the principal areas involved – it is not intended to be fully comprehensive of all brain areas involved.

The ascending reticular activating system (ARAS) is responsible for promoting wakefulness during the day.6

 

Orexin helps to maintain this wakefulness by reinforcing the activity of these wake-promoting neurotransmitters.6,7

 

In people with chronic insomnia, areas
of wakefulness remain active at night. This overactive wake-signalling, known as hyperarousal, impairs sleep.4,5,8

5-HT, serotonin; ACh, acetyl choline; ARAS, ascending reticular activating system;
DA, dopamine; HA, histamine; NA, noradrenaline; ORX, orexin.

QUVIVIQ™ mechanism of action

Figure adapted from Saper, et al. 2005 and QUVIVIQ™ SmPC.

Disclaimer: this image is a representation of this state in the brain and the principal areas involved – it is not intended to be fully comprehensive of all brain areas involved.

Dual orexin receptor antagonists (DORAs), such as QUVIVIQ™, block the wake-promoting action of orexin and, in turn, may target and reduce the overactive wake-signalling characteristic of insomnia.1,3,7

 

Selectively blocking the action of orexin neurotransmission prevents this pathway from stimulating the ascending reticular activating system, thereby promoting sleep without widespread
inhibition of the central nervous system (CNS).3,7

5-HT, serotonin; ACh, acetyl choline; ARAS, ascending reticular activating system; CNS, central nervous system; DA, dopamine; DORA, dual orexin receptor antagonist; HA, histamine; NA, noradrenaline; ORX, orexin.

Inclusion criteria in the QUVIVIQ™ trial programme2​

Participants were included in the trial if they met all of the following criteria:

  • Adults (aged ≥18 years)
  • Chronic insomnia (insomnia disorder) {according to the Diagnostic and Statistic Manual of Mental Disorders, fifth edition [DSM-5]} that was of moderate or severe intensity at screening (Insomnia Severity Index score ≥15)
  • Self-reported history of disturbed sleep (including all of the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, self reported sleep time of ≤6.5 hours) on at least 3 nights per week for at least 3 months before screening

During the placebo run-in period:

  • Self-reported sleep parameters had to be met on at least 3 of 7 nights
  • Polysomnography criteria had to be met (including all of the following: latency
    to persistent sleep [LPS] ≥20 min, wake time after sleep onset [WASO] ≥30 min,
    and mean total sleep time of <7 hours)

Baseline characteristics

IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LPS, latency to persistent sleep; SD, standard deviation; USA, United States of America; WASO, wake after sleep onset.

Exclusion criteria in the QUVIVIQ™ trial programme2​

Participants were excluded from the trial if they met any of the following criteria:

 

  • Self-reported daytime napping (≥1 hour per day on ≥3 days per week)
  • A history of suicidal ideation or attempt
  • Acute or chronic psychiatric condition not controlled by therapy
  • Severe depression
  • Alcohol or drug misuse
  • An apnoea hypopnoea index of 15 events per hour or higher (per American Academy of Sleep Medicine Criteria)
  • An event associated with oxygen saturation of less than 80% (assessed by polysomnography)
  • Periodic limb movement index of 15 or more events per hour (assessed by polysomnography)
  • Restless leg syndrome
  • Circadian rhythm disorder
  • Rapid-eye-movement behaviour disorder
  • Narcolepsy

Exclusion criteria in the QUVIVIQ™ trial programme2​

Participants were excluded from the trial if they met any of the following criteria:

 

  • Self-reported daytime napping (≥1 hour per day on ≥3 days per week)
  • A history of suicidal ideation or attempt
  • Acute or chronic psychiatric condition not controlled by therapy
  • Severe depression
  • Alcohol or drug misuse
  • An apnoea hypopnoea index of 15 events per hour or higher (per American Academy of Sleep Medicine Criteria)
  • An event associated with oxygen saturation of less than 80% (assessed by polysomnography)
  • Periodic limb movement index of 15 or more events per hour (assessed by polysomnography)
  • Restless leg syndrome
  • Circadian rhythm disorder
  • Rapid-eye-movement behaviour disorder
  • Narcolepsy

Inclusion criteria in the QUVIVIQ™ trial programme2​

Participants were included in the trial if they met all of the following criteria:

  • Adults (aged ≥18 years)
  • Chronic insomnia (insomnia disorder) {according to the Diagnostic and Statistic Manual of Mental Disorders, fifth edition [DSM-5]} that was of moderate or severe intensity at screening (Insomnia Severity Index score ≥15)
  • Self-reported history of disturbed sleep (including all of the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, self reported sleep time of ≤6.5 hours) on at least 3 nights per week for at least 3 months before screening

During the placebo run-in period:

  • Self-reported sleep parameters had to be met on at least 3 of 7 nights
  • Polysomnography criteria had to be met (including all of the following: latency
    to persistent sleep [LPS] ≥20 min, wake time after sleep onset [WASO] ≥30 min,
    and mean total sleep time of <7 hours)

Baseline characteristics

IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LPS, latency to persistent sleep; SD, standard deviation; USA, United States of America; WASO, wake after sleep onset.

Baseline characteristics

IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; LPS, latency to persistent sleep; SD, standard deviation; USA, United States of America; WASO, wake after sleep onset.

Exclusion criteria in the QUVIVIQ™ trial programme2​

Participants were excluded from the trial if they met any of the following criteria:

 

  • Self-reported daytime napping (≥1 hour per day on ≥3 days per week)
  • A history of suicidal ideation or attempt
  • Acute or chronic psychiatric condition not controlled by therapy
  • Severe depression
  • Alcohol or drug misuse
  • An apnoea hypopnoea index of 15 events per hour or higher (per American Academy of Sleep Medicine Criteria)
  • An event associated with oxygen saturation of less than 80% (assessed by polysomnography)
  • Periodic limb movement index of 15 or more events per hour (assessed by polysomnography)
  • Restless leg syndrome
  • Circadian rhythm disorder
  • Rapid-eye-movement behaviour disorder
  • Narcolepsy

Inclusion criteria in the QUVIVIQ™ trial programme2​

Participants were included in the trial if they met all of the following criteria:

  • Adults (aged ≥18 years)
  • Chronic insomnia (insomnia disorder) {according to the Diagnostic and Statistic Manual of Mental Disorders, fifth edition [DSM-5]} that was of moderate or severe intensity at screening (Insomnia Severity Index score ≥15)
  • Self-reported history of disturbed sleep (including all of the following: ≥30 min to fall asleep, ≥30 min awake during sleep time, self reported sleep time of ≤6.5 hours) on at least 3 nights per week for at least 3 months before screening

During the placebo run-in period:

  • Self-reported sleep parameters had to be met on at least 3 of 7 nights
  • Polysomnography criteria had to be met (including all of the following: latency
    to persistent sleep [LPS] ≥20 min, wake time after sleep onset [WASO] ≥30 min,
    and mean total sleep time of <7 hours)

The QUVIVIQ™ trial programme was designed to assess both the night and day impact of chronic insomnia2,10

The safety and efficacy of QUVIVIQ™ was evaluated in two multicentre, randomised, double-blind, parallel-group, placebo-controlled Phase 3 studies2

  • Select inclusion criteria:

  • Age ≥18 years

  • Chronic insomnia (insomnia disorder) of moderate or severe intensity according to DSM-5 criteria (Insomnia Severity Index score ≥15)
  • Select exclusion criteria:

  • Any other condition causing insomnia

  • Ongoing cognitive behavioural therapy, shift work, travel over time zones

  • Treatment with central nervous system-active drugs for a minimum of 14 days prior to visit*10

Key primary endpoints:

Change from baseline to Month 1 and 3
measured by polysomnography in:

  • Latency to persistent sleep (LPS)
  • Wake after sleep onset (WASO)

Key secondary endpoints:

Change from baseline at Months 1 and 3 for:

  • Patient-reported change in total sleep time (sTST)
  • Patient reported change in score for sleepiness domain of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ)

After completion of 3 months of study treatment, participants
were able to join a 9-month placebo-controlled extension trial

* Including over the counter medication and herbal medicines.10
† A 25 mg dose is recommended for patients with moderate hepatic impairment, or those using moderate CYP3A4 inhibitors (e.g. erythromycin, ciprofloxacin, cyclosporine).1
 ‡ A 10 mg dose is not licensed for use, and therefore not presented.1

Special warnings and precautions for use

Elderly patients1

No dose adjustment is required in elderly patients (>65 years). Because of the general risk of falls in the elderly, QUVIVIQ™ should be used with caution in this population, although clinical studies did not show an increase in the incidence of falls on QUVIVIQ™ compared to placebo.

 

QUVIVIQ™ should be administered with caution in patients older than 75 years since efficacy and safety data in this population are limited.

 

No data are available in patients older than 85 years.

Special warnings and precautions for use

CNS-depressant effects1

CNS, central nervous system.

Because QUVIVIQ™ acts by reducing wakefulness, patients should be cautioned about engaging in potentially hazardous activities, driving, or operating heavy machinery unless they feel fully alert, especially in the first few days of treatment. Caution should be exercised when prescribing QUVIVIQ™ concomitantly with CNS-depressant medicinal products due to potentially additive effects, and a dose adjustment of either QUVIVIQ™ or the concomitant CNS-depressants should be considered. Patients should be cautioned about drinking alcohol during treatment with QUVIVIQ™.

Special warnings and precautions for use

Sleep paralysis, hallucinations and cataplexy-like symptoms1

Sleep paralysis and hypnagogic/hypnopompic hallucinations can occur with QUVIVIQ™, mainly during the first weeks of treatment. Symptoms similar to mild cataplexy have been reported with dual orexin receptor antagonists. Prescribers should explain the nature of these events to patients when prescribing QUVIVIQ™. Should such events occur, patients need to be further evaluated and, depending on the nature and severity of the events, discontinuation of treatment should be considered.

Special warnings and precautions for use

Worsening of depression
and suicidal ideation1

In primarily depressed patients treated with hypnotics, worsening of depression and suicidal thoughts and actions have been reported. As with other hypnotics, QUVIVIQ™ should be administered with caution in patients exhibiting symptoms of depression. Isolated cases of suicidal ideation have been reported in Phase 3 clinical studies, in subjects with pre-existing psychiatric conditions and/or stressful living conditions, across all treatment groups, including placebo. Suicidal tendencies may be present in patients with depression and protective measures may be required.

Special warnings and precautions for use

Patients with psychiatric
co-morbidities1

QUVIVIQ™ should be administered with caution in patients with psychiatric co-morbidities since efficacy and safety data in this patient population are limited.

Special warnings and precautions for use

Patients with compromised
respiratory function1

COPD, chronic obstructive pulmonary disease;
FEV1, forced expiratory volume in one second;
OSA, obstructive sleep apnoea.

QUVIVIQ™ did not increase the frequency of apnoea/hypopnoea events or cause oxygen desaturation in patients with mild or moderate OSA, nor did it cause oxygen desaturation in patients with moderate COPD. QUVIVIQ™ has not been studied in patients with severe OSA (apnoea hypopnoea index ≥30 events per hour) or with severe COPD
(FEV1 <40% of predicted).

 

Caution should be exercised when prescribing QUVIVIQ™ to patients with severe OSA and severe COPD.

Special warnings and precautions for use

Potential for abuse
and dependence1

There was no evidence of abuse or withdrawal symptoms indicative of physical dependence upon treatment discontinuation in clinical studies with QUVIVIQ™ in subjects with insomnia. In an abuse liability study of QUVIVIQ™ (50, 100 and 150 mg) conducted in non-insomniac recreational drug users (n=72), QUVIVIQ™ (100 and 150 mg) produced similar “drug liking” ratings as zolpidem (30 mg). Because individuals with a history of abuse or addiction to alcohol or other substances may be at increased risk for abuse of QUVIVIQ™, these patients should be followed carefully.

Special warnings and precautions for use

Patients with hepatic
impairment1

Use is not recommended in patients with severe hepatic impairment.

 

The recommended dose of QUVIVIQ™ for patients with moderate hepatic
impairment is 25 mg once per night.

What should you keep in mind when prescribing QUVIVIQ™ for your patients with chronic insomnia?

If your patient forgets to take QUVIVIQ™ before bed, that dose should not be taken during the night.1
No dose adjustment is needed for patients with renal impairment or elderly patients (>65 years) with chronic insomnia. Limited data is available for patients aged ≥75 years.1
The consumption of grapefruit or grapefruit juice in the evening should be avoided.1
Patients should be cautioned about drinking alcohol during treatment with QUVIVIQ™.1 Individuals with a history of abuse or addiction to alcohol or other substances may be at increased risk for abuse of QUVIVIQ™, these patients should be followed carefully.1
If your patient is pregnant, QUVIVIQ™ should only be used if the clinical condition of the patient requires treatment. If they are breastfeeding, a decision must be made whether to discontinue breastfeeding or QUVIVIQ™, the benefit of breastfeeding for the child and the benefit of therapy for the patient must be taken into account.1

Clinical judgement is required for patients on CNS depressants and the use of QUVIVIQ™ is not recommended in patients with severe hepatic impairment.1

CNS, central nervous system.

You are now leaving QUVIVIQ.co.uk

You are now leaving www.QUVIVIQ.co.uk. The linked website provides helpful information if you are having trouble sleeping. It is neither owned or controlled by Idorsia Pharmaceuticals Ltd. Idorsia accepts no responsibility for the content or services of the linked site.

Cancel
Go to link

UK-DA-00254 | Date of preparation: November 2023
Copyright © 2023 Idorsia Pharmaceuticals Ltd

The IDSIQ: A patient-reported outcome (PRO) measure of daytime functioning, validated according to FDA guidelines2,11

The Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) allows participants to assess how they felt throughout the day:2,11

 

IDSIQ was assessed every evening at home2
IDSIQ total score ranges from 0–14011
Clinically meaningful changes from baseline:11
≥20 reduction for total score

≥4 reduction for sleepiness domain

Sleepiness
domain score
(0–40)

How energetic did you feel today?

How mentally tired did you feel today?

How physically tired did you feel today?

How sleepy did you feel today?

≥9 reduction for alert/cognition

Alert/cognition
domain score
(0–60)

How clear-headed did you feel today?

How well were you able to concentrate today?

How forgetful did you feel today?

How much of an effort was it to perform daily activities today?

How refreshed did you feel today?

How awake did you feel today?

≥4 reduction for mood

Mood
domain score
(0–40)

How worried did you feel today?

How frustrated by your lack of sleep did you feel today?

How irritable did you feel today?

How stressed did you feel today?

FDA, Food and Drug Administration; IDSIQ, Insomnia Daytime Symptoms and Impacts Questionnaire; PRO, patient reported outcome.

You are now leaving QUVIVIQ.co.uk

You are now leaving www.QUVIVIQ.co.uk. The linked website provides helpful information if you are having trouble sleeping. It is neither owned or controlled by Idorsia Pharmaceuticals Ltd. Idorsia accepts no responsibility for the content or services of the linked site.

Cancel
Go to link

UK-DA-00254 | Date of preparation: November 2023
Copyright © 2023 Idorsia Pharmaceuticals Ltd

Confirming your contact information and preferences means that you agree that we, Idorsia, manage your personal data in our Client Relationship Management system to document, customise, plan, and conduct our interactions with you and, to analyse and segment your interactions, interests, preferences, and scientific activities in order to interact with you in a way we think is most relevant to you.

It also means that you agree that we will send you Idorsia standard or personalised medical, company or product related information and material via email based on your choices and on what we think is of interest to you. You further consent that we process your personal data for this.

For more information about us, our processing of your personal data and your rights, please see our Privacy Notice.

Welcome to the Idorsia UK
Healthcare Professional portal

This information is intended for UK Healthcare Professionals only.

By entering this site you are confirming that you are a UK Healthcare Professional.

I am a member of the public

UK-DA-00217 | Date of preparation: October 2023

Copyright © 2023 Idorsia Pharmaceuticals Ltd