Frequently asked questions about QUVIVIQ™
While QUVIVIQ™ should be used for as short as possible, there is no treatment duration limit if periodically reassessed.1
The appropriateness of continued treatment should be assessed within 3 months and periodically thereafter. Clinical data are available for up to 12 months of continuous treatment. Treatment can be stopped without down-titration.1
If a patient forgets to take QUVIVIQ™ at bedtime, that dose should not be taken during the night.1
No dose adjustment is required in elderly patients (>65 years). The recommended dose for adults is 50 mg once per night.1
Because of the general risk of falls in the elderly, QUVIVIQ™ should be used with caution in this population. However, clinical studies did not show an increase in the incidence of falls on QUVIVIQ™ vs placebo.1
QUVIVIQ™ should be administered with caution in patients older than 75 years, since the efficacy and safety data in this population are limited.1
No data are available in patients over 85 years.1
QUVIVIQ™ can be administered to patients with any degree of renal function impairment without the need for dose adjustment.1
QUVIVIQ™ can be administered to patients with mild hepatic impairment without the need for dose adjustment.1 The recommended dose of QUVIVIQ™ for patients with moderate hepatic impairment is 25 mg once per night.1
QUVIVIQ™ is not recommended in patients with severe hepatic impairment as it has not been studied in this group.1
For more details about use in patients with hepatic impairment, please see Section 5.2 of the Summary of Product Characteristics.
Co-administration with moderate CYP3A4 inhibitors:
The recommended dose when used with moderate CYP3A4 inhibitors (e.g. erythromycin, ciprofloxacin, cyclosporine) is 25 mg once per night.1
Co-administration with CNS depressants:
In the case of co-administration with CNS-depressant medicinal products, dose adjustments of either QUVIVIQ™ or the concomitant medicinal product may be required due to potentially additive effects.1
For more details about interactions with other medicines and other forms of interaction, please see Section 4.5 of the summary of product characteristics.
Upon discontinuation of QUVIVIQ™ in clinical trials there was no evidence of physical dependence even when used nightly up to 12 months and no evidence of abuse or withdrawal symptoms in patients with insomnia.1
For more details, please see Section 4.4 of the Summary of Product Characteristics.
Frequently asked questions your patients may have about QUVIVIQ™
When patients come to you with a question on QUVIVIQ™, here is a guide to how you can respond in patient-friendly terms.
QUVIVIQ™ should be taken within 30 minutes before you go to bed, and time to sleep onset may be delayed if it’s taken soon after a large meal.1 You should also continue to practise good sleep hygiene when you are taking QUVIVIQ™.
Scientists believe that people with chronic insomnia have an overactive brain at night, meaning parts of the brain that should be in sleep mode are still active.2,3
Orexin is a substance produced by the brain that helps keep you awake. By blocking the action of orexin, QUVIVIQ™ decreases your wake drive so you can fall asleep and helps to improve your ability to function normally during the day.1
You should be cautious about drinking alcohol when you’re being treated with QUVIVIQ™ as this can increase the risk of impaired balance and co-ordination.1
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should ask your doctor for advice before taking this medicine.1
It is not known if QUVIVIQ™ passes into breast milk. You should talk to your doctor about the best way to feed your baby during treatment with QUVIVIQ™.1
Abbreviations
CNS, central nervous system; CYP3A4, cytochrome P450 3A4; FAQ, frequently asked question.
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
- QUVIVIQ™ Idorsia Pharmaceuticals LTD, Summary of Product Characteristics. Last updated: March 2023.
- Nofzinger E, et al. Am J Psychiatry. 2004; 161: 2126–2129.
- Riemann D, et al. Sleep Med Rev. 2010; 14(1): 19–31.
UK-DA-00124 I Date of preparation: June 2023
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