Quviviq (Daridorexant) for Adult Insomnia

Recommended Dosing

The recommended dosage of Quviviq is 25 mg to 50 mg taken orally once nightly within 30 minutes of bedtime, with at least 7 hours remaining before planned awakening. 1

Standard dosing: Start with 25 mg or 50 mg based on symptom severity; the 50 mg dose provides maximal efficacy for both nighttime sleep parameters and daytime functioning 2
Timing: Take within 30 minutes of going to bed; time to sleep onset may be delayed if taken with or soon after a meal 1
Duration: Studied safely for up to 3 months in clinical trials; designed with an 8-hour effect duration to minimize residual daytime impairment 3, 2

Dose Adjustments

Moderate hepatic impairment (Child-Pugh 7–9): Maximum 25 mg once nightly 1
Severe hepatic impairment (Child-Pugh ≥10): Not recommended 1
Elderly patients (≥65 years): No dose reduction required; older adults tolerate 50 mg without increased adverse events or residual morning effects 2
Concomitant moderate CYP3A4 inhibitors: Reduce to 25 mg once nightly 1
Concomitant strong CYP3A4 inhibitors or moderate/strong CYP3A4 inducers: Avoid concomitant use 1

Contraindications

Quviviq is absolutely contraindicated in two specific populations: 1

Narcolepsy: Orexin antagonism would worsen excessive daytime sleepiness 1
Hypersensitivity to daridorexant: Angioedema with pharyngeal involvement has been reported 1

Precautions and Safety Warnings

CNS Depression and Next-Day Impairment

Quviviq causes CNS depression that can impair daytime wakefulness even when used as prescribed; effects may persist for several days after discontinuation 1
Driving ability was impaired in some subjects taking 50 mg in clinical studies 1
Risk of daytime impairment increases if taken with less than 7 hours of sleep remaining or at higher-than-recommended doses 1
Avoid driving and activities requiring complete mental alertness if Quviviq is taken under these circumstances 1

Concomitant CNS Depressants

Co-administration with other CNS depressants (benzodiazepines, opioids, tricyclic antidepressants, alcohol) increases the risk of CNS depression and daytime impairment 1
Dosage adjustments of both Quviviq and concomitant CNS depressants may be necessary due to potentially additive effects 1
The use of Quviviq with other insomnia medications is not recommended 1

Special Populations

Older adults (≥65 years): Daridorexant 50 mg is safe and effective without increased adverse events; older patients particularly require the 50 mg dose to improve daytime functioning 2
Pregnancy/lactation: Safety data not established in prescribing information 1

Drug Interactions

CYP3A4 Inhibitors

Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin): Avoid concomitant use 1
Moderate CYP3A4 inhibitors (e.g., diltiazem, erythromycin, fluconazole): Reduce Quviviq to 25 mg once nightly 1

CYP3A4 Inducers

Strong or moderate CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's wort): Avoid concomitant use; these agents reduce daridorexant exposure and efficacy 1

CNS Depressants

Benzodiazepines, opioids, tricyclic antidepressants, alcohol: Additive CNS depression; dosage adjustments of both agents may be necessary 1

Adverse Effects

Common Adverse Events

Daridorexant has a favorable safety profile with low overall adverse event rates comparable to placebo: 4, 5

Fatigue: Most commonly reported 4
Somnolence: Slightly higher incidence than placebo (RR 1.19) 5
Nasopharyngitis 4
Headache 4
Diarrhea 4
Gait disturbance 4

Serious Adverse Events

Angioedema with pharyngeal involvement: Reported post-marketing 1
Sleep paralysis: One case reported in older adults in clinical trials 2
No cases of narcolepsy, cataplexy, or complex sleep behaviors were observed in clinical trials 2

Falls Risk

In both younger and older adults, there were fewer falls on daridorexant compared to placebo 2

Morning Residual Effects

Daridorexant improved Visual Analog Scale morning sleepiness scores in both older and younger adults; mean improvement was 15.9 points in older adults and 14.9 points in younger adults at 3 months 2
Initial data suggest daridorexant does not impair next-day functioning, a common issue with other insomnia agents 4

Efficacy Data

Objective Sleep Parameters

Wake after sleep onset (WASO): Reduced by 19.6 minutes in older adults and 17.4 minutes in younger adults at 3 months with 50 mg dose 2
Latency to persistent sleep (LPS): Reduced by 14.9 minutes in older adults and 9.7 minutes in younger adults at 3 months with 50 mg dose 2
Meta-analysis findings: 50 mg superior to placebo for WASO (MD -13.26 min), LPS (MD -7.23 min), and total sleep time (MD +14.80 min) 6, 5

Subjective Sleep Parameters

Subjective total sleep time (sTST): Increased by 59.9 minutes in older adults and 57.1 minutes in younger adults at 3 months with 50 mg dose 2

Daytime Functioning

Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ): Daridorexant 50 mg progressively improved total and domain scores from week 1 onward in both older and younger adults 2
The 25 mg dose improved IDSIQ scores only in younger adults, not in older adults 2

Alternative Therapies

First-Line Non-Pharmacologic Treatment

Cognitive Behavioral Therapy for Insomnia (CBT-I) must be initiated before or alongside any pharmacotherapy, as it provides superior long-term efficacy with sustained benefits after discontinuation. 7

Core components include stimulus control, sleep restriction, relaxation techniques, and cognitive restructuring 7
CBT-I can be delivered via individual therapy, group sessions, telephone, web-based modules, or self-help books 7

Alternative Pharmacologic Options

For Sleep-Onset and Maintenance Insomnia

Eszopiclone 2–3 mg: Increases total sleep time by 28–57 minutes; moderate-to-large improvement in sleep quality 7
Zolpidem 10 mg (5 mg if ≥65 years): Reduces sleep latency by ~25 minutes; adds ~29 minutes to total sleep time 7

For Sleep-Maintenance Insomnia

Low-dose doxepin 3–6 mg: Reduces wake after sleep onset by 22–23 minutes; minimal anticholinergic effects; no abuse potential 7, 8
Suvorexant 10 mg: Reduces wake after sleep onset by 16–28 minutes; lower risk of cognitive/psychomotor impairment than benzodiazepine-type agents 7

For Sleep-Onset Insomnia

Ramelteon 8 mg: Melatonin-receptor agonist; no abuse potential; not DEA-scheduled; appropriate for patients with substance use history 7
Zaleplon 10 mg (5 mg if ≥65 years): Ultrashort half-life (~1 hour); minimal next-day sedation 7

Agents to Avoid

Trazodone: Provides only ~10 min reduction in sleep latency with no improvement in subjective sleep quality; adverse events in ~75% of older adults 7, 8
Over-the-counter antihistamines (diphenhydramine, doxylamine): Lack efficacy; strong anticholinergic effects; tolerance develops in 3–4 days 7, 8
Traditional benzodiazepines (lorazepam, temazepam, clonazepam): Higher risk of dependence, falls, cognitive impairment, respiratory depression, and associations with dementia and fractures 7
Antipsychotics (quetiapine, olanzapine): Weak evidence for insomnia; significant risks including weight gain, metabolic syndrome, and increased mortality in elderly with dementia 7
Melatonin supplements: Produce only ~9 min reduction in sleep latency; insufficient evidence 7

Clinical Implementation Algorithm

Initiate or optimize CBT-I immediately for all patients with chronic insomnia 7
If CBT-I alone is insufficient after 4–8 weeks, add daridorexant:
- Start with 25 mg or 50 mg based on severity and patient factors 1
- Older adults (≥65 years) particularly benefit from 50 mg for daytime functioning improvement 2
Reassess at 1–2 weeks: Evaluate sleep-onset latency, total sleep time, nocturnal awakenings, daytime functioning, and adverse effects 7
Continue for up to 3 months or longer if effective and well-tolerated 2
Maintain CBT-I throughout pharmacotherapy to facilitate eventual medication tapering 7

Common Pitfalls to Avoid

Prescribing Quviviq without concurrent CBT-I: Behavioral therapy provides more durable benefits than medication alone 7
Taking Quviviq with less than 7 hours of sleep remaining: Markedly increases next-day impairment risk 1
Combining Quviviq with other insomnia medications: Not recommended due to additive CNS depression 1
Using strong CYP3A4 inhibitors or inducers concurrently: Avoid these combinations 1
Under-dosing older adults: The 50 mg dose is safe and necessary for maximal daytime functioning improvement in patients ≥65 years 2
Failing to screen for narcolepsy before prescribing: Absolute contraindication 1

What are the recommended dosing, contraindications, precautions, drug interactions, adverse effects, and alternative therapies for Quviviq (daridorexant) in an adult with insomnia?

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