This situation requires withdrawal as a precaution, reports the drug agency.
Several boxes of insomnia drugs have been recalled in France, reports the National Medicines Safety Agency (ANSM) in a statement dating from June 2025. This recall follows detection on the French box market of a lot intended for the German market. Although the drug in question is equivalent to composition and therapeutic use to that authorized in France, this situation requires a removal for a precautionary measure, indicates the laboratory which markets these drugs (Idorsia Pharmaceuticals France SAS). In other words, it is therefore a legal reminder aimed at guaranteeing the total compliance of products to national regulations, without health risks for patients.
The drug targeted, the German version of which was mistakenly found on the French market, is used in the management of certain sleep disorders. This recall targets only pharmacies and health establishments and not patients directly. In this context, no alert number has been awarded. In addition, the batch concerned has been distributed to a limited number of structures. However, for any question or request for information, the medical information service of the Idorsia Pharmaceuticals France SAS laboratory can be reached free of charge on 0 805 543 375.
The recall in question concerns the Quviviq 50 mg (Daridorexant-30 tablets) drugs identified under the reference LY9096 with a expiration date set at August 2028, can be read on the Courrier de l’Ansm. The active substance of the drug, the daredirexing, acts by blocking the action of orexin, a brain substance that promotes awakening, which helps fall asleep and remain asleep longer.
The treatment of chronic insomnia is based on a combined approach: first sleep hygiene measures and cognitive behavioral therapy (TCC), recognized as first-line treatment. In case of failure or punctual need, drug treatments like the Daridorexant can be prescribed. According to HAS data, between 800,000 and 1,600,000 adults would suffer from chronic insomnia in France.
