Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal

Abstract

Results support the efficacy and safety of PRM in primary insomnia patients aged 20-80 throughout 6-12 months of continuous therapy. PRM discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of endogenous melatonin production.