OBJECTIVES: Instanyl^® (fentanyl nasal spray) received European market authorisation in July 2009 for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain, with precise instructions on indications for use and dosage. The study objectives were to evaluate patient-reported misuse, abuse, and diversion of Instanyl^® in real-life in France. METHODS: Cross-sectional observational study of patients with an Instanyl^® dispensation from a non-hospital pharmacy. An anonymous self-administered questionnaire was distributed to patients at the time of drug dispensation between 27 July 2011 and 12 November 2012. The questionnaire collected data on indication, contraindications, Instanyl^® use, and previous completion of the questionnaire. RESULTS: Among the 272 eligible questionnaires (at least one item completed in addition to age, gender, time since first prescription, and absence of previous completion of the questionnaire), all patients were adult and 95% declared misuse. Among the 160 patients who declared having cancer, 94% declared misuse: 76% declared at least one indication/contraindication misuse and 86% at least one posology misuse. Widening the definition of use for breakthrough pain to use for both breakthrough and chronic pain in cancer patients, reduced the indication/contraindication misuse (63%), but when posology misuse was also considered this did not markedly change overall misuse (93%). Abuse of Instanyl^® (using the drug for emotional reasons, relaxation, or sleep disorders) concerned 21 patients (15 with cancer, and 6 without); diversion (passing the drug to another person) concerned 2 patients (1 with cancer and 1 without). CONCLUSIONS: Misuse of Instany^l® was widespread. Nearly half reported not to have cancer, and among those who did, only a few used this drug correctly. There seems to be a communication deficit as to the proper prescribing of this drug, and its proper use when prescribed.