PMCPA AUTH/3856/11/23: Complainant v Idorsia (Quviviq) — ‘chronic insomnia’ wording in GP website ads (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/3856/11/23
Company	Idorsia
Complainant	Anonymous, contactable complainant
Product	Quviviq (daridorexant)
Channel/material	Two electronic banner advertisements on a UK news website for general practitioners
Job codes	UK-DA-00181; UK-DA-00183
Core allegation	Use of “chronic insomnia” allegedly inconsistent with licensed indication; alleged off-licence promotion
Applicable Code	2021
Clauses considered	5.1, 6.1, 11.2
Panel decision	No breach of Clause 5.1; No breach of Clause 6.1 (x2); No breach of Clause 11.2 (x2)
Appeal	No appeal
Complaint received	21 November 2023
Case completed	18 February 2025

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, contactable complainant challenged two Idorsia banner advertisements on a UK news website for general practitioners.
Both ads related to Quviviq (daridorexant) for insomnia and used the term “chronic insomnia”.
The complainant alleged the term “chronic insomnia” was broader than the SmPC indication and therefore amounted to off-licence promotion.
Ad 1 (UK-DA-00181) promoted a ~2-minute expert video titled “Overactive signalling as a cause of Chronic Insomnia”.
Ad 2 (UK-DA-00183) promoted a “plain language summary” titled “Summary from two Phase 3 studies on efficacy and safety of daridorexant in patients with chronic insomnia”.
Idorsia argued “chronic insomnia” is consistent with the SmPC wording (symptoms ≥3 months and considerable impact on daytime functioning) and cited WHO ICD-11, NICE CKS and NICE TA922.

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No breach of Clause 6.1 (x2) (misleading information/claims/comparisons) for either advertisement.
No breach of Clause 11.2 (x2) (promotion outside the marketing authorisation) for either advertisement.
No breach of Clause 5.1 (high standards) (consequential to the above).
No appeal.

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