Low-Dose Sublingual Fentanyl Safe, Effective in Patients Receiving Lower Opioid Doses

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Sublingual fentanyl given in low doses may be safe and effective for breakthrough pain in patients with cancer who are receiving lower doses of opioids for background analgesia, according to a study published in the journal Supportive Care in Cancer.1

Sublingual fentanyl is approved by the US Food and Drug Administration (FDA) for the management of breakthrough pain in adults with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain; however, the effect of low doses of sublingual fentanyl in patients who are receiving low opioid doses for background analgesia remains unclear.

For the study, investigators enrolled 51 patients presenting breakthrough pain episodes and receiving low doses of opioids for background pain, defined as less than 60 mg or oral morphine equivalents.

Results showed that, on average, patients experienced 3.3 episodes of breakthrough pain, with 4 patients having no episodes of breakthrough pain.

Researchers found that pain intensity significantly decreased at 5 minutes, 10 minutes, 15 minutes, and 30 minutes after the administration of sublingual fentanyl (P <.0005). In addition, a substantial proportion of patients experienced a pain reduction of 50% at all 4 time points.

With respect to safety, adverse events were mild and were already present in the majority of cases, as a result of basal opioid treatment or the nature of disease. The investigators did not observe any serious adverse effects in the 2 hours after fentanyl administration.


1. Mercadente S, Adile C, Cuomo A, et al. The use of low doses of a sublingual fentanyl formulation for breakthrough pain in patients receiving low doses of opioids. 2016 Oct 15. doi: 10.1007/s00520-016-3457-y. [Epub ahead of print]

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