Melatonin levels decline with age, an important factor in poor quality sleep among older people.1 In addition to difficulty falling asleep, sleep in older populations is characterized by increased fragmentation of the sleep architecture and sleep maintenance problems. Melatonin supplementation has been shown to promote and maintain sleep in older populations.1 Previously, prolonged-release melatonin (PRM), which has been marketed internationally, was designed to provide a serum melatonin profile more closely related to the normal physiological release pattern compared with immediate-release melatonin (IR-melatonin).
A pharmacokinetic study looking at serum melatonin levels in healthy males after ingestion of the 2 mg dose of PR-M shows peak concentration of melatonin in the blood occurring at 2.6 hours and persisting over 3.5 hours after ingestion and declining towards the morning.1 IR-melatonin peaks after 2 hours and rapidly declines over the next 2 hours.
In well-conducted sleep studies, PR-M demonstrated statistically significant improvements in sleep quality, morning alertness, sleep latency, and quality of life in patients aged 55 years and older compared with IR-melatonin and placebo.1,2 In addition, as shown in Table 1,
Pooled Analysis (N. I, VII, IX). QOS, (quality of sleep); BFW,
(behavior following wakefulness)
the responder rate for concomitant improvement in quality of sleep and morning alertness, and in each of them separately, was significantly higher for PR-M compared with placebo, in studies reported by the PR-M innovator.2
In spite of an improved formulation, a lower than anticipated plateau time for PR-M (4.4 h)2 resulted from lower absorption in the intestines with this formulation.3 Building upon the body of evidence from PR-M studies, the patented Ion Powered Pump (IPP) delivery system utilized in continuous-release and absorption melatonin (CRA-melatonin) was designed to overcome the challenges of absorption in the intestines3 and, thereby, extend the plateau time (known as the Mesa Wave) to approximate the target of 7 hours and improve sleep maintenance.