GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Daridorexant tablets (Quviviq, adults)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug2 sources available - open source summaries, references and comparisons

Quviviq

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Official source

Daridorexant tablets (Quviviq, adults) - selected U.S. label sections

Product / population
Adult QUVIVIQ oral tablets.
Renal measure
Cockcroft-Gault CrCl in renal PK assessment; severe group below 30 mL/min, not on dialysis.

Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.

Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.

Renal pharmacokinetic comments

No clinically significant effect of mild through severe renal impairment on daridorexant pharmacokinetics was identified. The severe-impairment study involved patients not receiving dialysis. Do not extrapolate that finding to a hemodialysis schedule.

Source revision: Revision not captured; retrieval date is not the revision date. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a2d1503-b816-40c9-9fac-7e03c5a3bcef

Scope: Local label summary; independent clinical review pending. Not a two-source validated protocol. GlobalRPh v6.6.

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Official product label

Daridorexant tablets (Quviviq, adults) - selected U.S. label sections

Adult QUVIVIQ oral tablets.

Renal method: Cockcroft-Gault CrCl in renal PK assessment; severe group below 30 mL/min, not on dialysis.
Retrieved: 2026-09-05

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GlobalRPh RX List

GlobalRPh RX List - Quviviq

Pharmacokinetic observation only. A drug-exposure observation is not itself a dose recommendation.

Adult product-specific renal information; not a complete prescribing regimen.

Renal method: Cockcroft-Gault CrCl, mL/min; nondialysis population.
Retrieved: 2026-09-07

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Original content / product scopeDaridorexant tablets (Quviviq, adults) - selected U.S. label sectionsGlobalRPh RX List - Quviviq
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Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a2d1503-b816-40c9-9fac-7e03c5a3bcef

Product and population scope

Adult QUVIVIQ oral tablets.

RDM32-daridorexant-quviviq-scope · Source section: Editorial scope for the selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Daridorexant tablets (Quviviq, adults) - selected U.S. label sections

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U.S. product labeling / DailyMed · Adult QUVIVIQ oral tablets.

Renal method: Cockcroft-Gault CrCl in renal PK assessment; severe group below 30 mL/min, not on dialysis.
Source date: Revision not captured; retrieval date is not the revision date.
Retrieved: 2026-09-05

Local label summary; independent clinical review pending. Not a two-source validated protocol.

Renal pharmacokinetic comments

No clinically significant effect of mild through severe renal impairment on daridorexant pharmacokinetics was identified. The severe-impairment study involved patients not receiving dialysis. Do not extrapolate that finding to a hemodialysis schedule.

RDM32-daridorexant-quviviq-1 · Source locator: 12.3, Specific Populations

Source-specific limits

Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.

Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a2d1503-b816-40c9-9fac-7e03c5a3bcef
Retrieved
2026-09-05
DailyMed Set ID
3a2d1503-b816-40c9-9fac-7e03c5a3bcef
Renal-function method
Cockcroft-Gault CrCl in renal PK assessment; severe group below 30 mL/min, not on dialysis.
Source date/version
Revision not captured; retrieval date is not the revision date.
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or a label PDF.
Local summary SHA-256
da6cdf50674a3e9413d84f2f0e7b761801c396da4247dcc7fe52e8335139500a
Locally imported selected renal sections

GlobalRPh RX List renal information

Rxlist

GlobalRPh RX List - Quviviq

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GlobalRPh-hosted RX List · Adult product-specific renal information; not a complete prescribing regimen.

Renal method: Cockcroft-Gault CrCl, mL/min; nondialysis population.
Source date: Source revision date not established in selected retrieval.
Retrieved: 2026-09-07

Label mirror, not independent corroboration. This is selected locally stored RX List content. Full monograph import and current official-label review are not implied.
Pharmacokinetic observation only. A drug-exposure observation is not itself a dose recommendation.

Selected source text imported locally; independent clinical review pending. Not a complete prescribing monograph.

Renal dosing, restrictions and evidence limits

The pharmacokinetic analysis found no clinically significant effect of mild through severe renal impairment, including Cockcroft-Gault clearance below 30 mL/min in patients not receiving dialysis. This selected statement is pharmacokinetic evidence, not a dialysis schedule. Hepatic function and CYP3A interactions have separate implications and should not be ignored because renal exposure was unchanged.

RDM34-rxlist-quviviq-drug-C1 · Source locator: Clinical pharmacology: specific populations.

Source identity and provenance
Source family
product_label_mirror
Source
https://globalrph.com/rx-list/quviviq-drug/
Retrieved
2026-09-07
Renal-function method
Cockcroft-Gault CrCl, mL/min; nondialysis population.
Source date/version
Source revision date not established in selected retrieval.
Hash meaning
SHA-256 of local authored summary only, not original HTML, PDF or SPL bytes.
Local summary SHA-256
fe8ccfe6c30cb7e0afd3866f5fd2328d025e2fa345c03c7cce2badd0cbe4407a

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 1 RX List, 0 professional, 0 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3a2d1503-b816-40c9-9fac-7e03c5a3bcef
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
c83f381eff00684ea62adcc11031148b7b52ca370f0cb0b16b29a13f6cda55bf
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

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