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Prolonged‐release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects
Author(s) -
LEMOINE PATRICK,
NIR TALI,
LAUDON MOSHE,
ZISAPEL NAVA
Publication year - 2007
Publication title -
journal of sleep research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.297
H-Index - 117
eISSN - 1365-2869
pISSN - 0962-1105
DOI - 10.1111/j.1365-2869.2007.00613.x
Subject(s) - melatonin , insomnia , alertness , primary insomnia , placebo , discontinuation , medicine , morning , sleep disorder , psychology , psychiatry , alternative medicine , pathology
Summary Melatonin, secreted nocturnally by the pineal gland, is an endogenous sleep regulator. Impaired melatonin production and complaints on poor quality of sleep are common among the elderly. Non‐restorative sleep (perceived poor quality of sleep) and subsequently poor daytime functioning are increasingly recognized as a leading syndrome in the diagnostic and therapeutic process of insomnia complaints. The effects of 3‐weeks prolonged‐release melatonin 2 mg (PR‐melatonin) versus placebo treatment were assessed in a multi‐center randomized placebo‐controlled study in 170 primary insomnia outpatients aged ≥55 years. Improvements in quality of sleep (QOS) the night before and morning alertness (BFW) were assessed using the Leeds Sleep Evaluation Questionnaire and changes in sleep quality (QON) reported on five categorical unit scales. Rebound insomnia and withdrawal effects following discontinuation were also evaluated. PR‐melatonin significantly improved QOS (−22.5 versus −16.5 mm, P = 0.047), QON (0.89 versus 0.46 units; P = 0.003) and BFW (−15.7 versus −6.8 mm; P = 0.002) compared with placebo. The improvements in QOS and BFW were strongly correlated (Rval = 0.77, P < 0.001) suggesting a beneficial treatment effect on the restorative value of sleep. These results were confirmed in a subgroup of patients with a greater symptom severity. There was no evidence of rebound insomnia or withdrawal effects following treatment discontinuation. The incidence of adverse events was low and most side‐effects were judged to be of minor severity. PR‐melatonin is the first drug shown to significantly improve quality of sleep and morning alertness in primary insomnia patients aged 55 years and older‐suggesting more restorative sleep, and without withdrawal symptoms upon discontinuation.