Objective: The literature examining the epidemiology, quality of life burden, cost, and treatment of diabetic peripheral neuropathy pain (DPNP) in U.S. adults was reviewed. Design: A comprehensive computerized literature review of DPNP was conducted using MEDLINE and other databases, which were searched from 1995 through August 2004 using the Medical Subject Headings diabetic neuropathies and pain combined with relevant terms. A supplementary MEDLINE search of clinical trials of pharmacological treatments for DPNP was conducted through July 2005. Results: The search resulted in 321 articles. Several epidemiological studies assessed diabetic peripheral neuropathy among patients with diabetes and reported prevalence rates of 26-47%. No estimates of DPNP prevalence were reported, although one study (N = 2,405) reported that 26.8% of participants with diabetes experienced either pain or tingling. Randomized clinical trials have been conducted of several medications and classes of medication in patients with DPNP, and the U.S. Food and Drug Administration has approved two drugs for DPNP. Several published studies reported that DPNP impairs quality of life. Estimates of the costs of DPNP in the United States were limited. One study estimated average annual pain medication costs of $1,004 per DPNP patient. Conclusions: This review of DPNP identifies gaps in the literature and highlights the need for further study. The establishment of a consistent definition and diagnostic code for DPNP would improve ability to collect data and understand the impact of DPNP on patients and the health care system. Well-designed, prospective studies are needed to better define the epidemiology and public health burden of DPNP.