Melatonin is increasingly used for the treatment of sleep disorders. Surge-sustained formulations consisting of combined immediate release and controlled release dosing may mimic the endogenous melatonin physiologic profile. However, relatively little is known about the pharmacokinetic properties of low dose (<0.5 mg) and high dose (>2 mg) melatonin in a combined immediate release/controlled release dose, especially in older adults who may also exhibit altered melatonin disposition. To assess this, we conducted a randomized, double-blind, placebo-controlled study of low (0.4 mg) and high (4.0 mg) dose melatonin (25% immediate release+75% controlled release) in 27 older adults with insomnia complaints and low endogenous melatonin levels to determine if melatonin pharmacokinetic properties differ between these two doses. The time to maximum level (1.3 hrs vs 1.5 hrs), elimination half-life (1.8 hrs vs 2.1 hrs), and apparent total clearance (379 l/hr vs 478 l/hr) did not differ significantly between the low and high dose arms, respectively. The maximum concentration was 405±93 pg/ml for the low dose arm and 3999±700 pg/ml for the high dose arm, both of which are substantially higher than physiologic melatonin levels for this age group. In addition, subjects in the high dose arm maintained melatonin levels >50 pg/ml for an average of 10 hours, which could result in elevated melatonin levels beyond the typical sleep period. Renal and liver function parameters remained stable after 6 weeks of treatment. The linear pharmacokinetic behavior of melatonin observed in the elderly can form the basis for future studies exploring a wider range of dosing scenarios to establish exposure-response relationships for melatonin-mediated sleep outcomes.

BackgroundThe use of CAM is at an all time high. There is very little research that compares the use of CAM in elders by ethnicity in rural settings. The purpose of the study was to determine if there was a difference between African American and Caucasian American rural elders on use of CAM and self-reported satisfaction with CAM.MethodsThe design was a descriptive, comparative study of 183 elders who reported the number of CAM used and satisfaction with CAM. A convenience sample was recruited through community service organizations in the state of Mississippi. The availability of elders through the support groups, sampling bias, subject effect, and self-report were limitations of the study.ResultsThe commonest examples of CAM used by rural elders were prayer, vitamins, exercise, meditation, herbs, chiropractic medicine, glucosamine, and music therapy. Significant findings on SES and marital status were calculated. Differences on ethnicity and demographic variables were significant for age, education, and the use of glucosamine.ConclusionsHealth care providers must be aware that elders are using CAM and are satisfied with their use. Identifying different uses of CAM by ethnicity is important for health care practitioners, impacting how health care is provided.

D iabetes is the fifth leading cause of death in America, affecting 17 million people or 6.2% of the population. In 2002, the direct cost of diabetes was $91.8 billion dollars in healthcare costs, with indirect costs of disability, work loss, and premature mortality at $40.2 billion dollars. 1 These alarming statistics are due in part to the rising problem of obesity and chronic diseases in our population, resulting in increased insulin resistance and increased rates of type 2 diabetes, which is most often diagnosed after the age of 40. Sleep disturbances and sleep loss are implicated in insulin resistance, a precursor to type 2 diabetes. Individuals who sleep more than 8 hours per day or less than 7 hours per day are at modestly increased risk of all-cause mortality, cardiovascular disease, and developing symptomatic diabetes. 2

The nocturnal administration of sodium oxybate in patients with narcolepsy was associated with statistically significant and clinically relevant improvements in functional status, an important component of quality of life.