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Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal Full Text
Therapeutics and Clinical Risk Management, 07/28/2011
Clinical Article
Lemoine P et al. - Results support the efficacy and safety of PRM in primary insomnia patients aged 20–80 throughout 6–12 months of continuous therapy. Prolonged-release melatonin (PRM) discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of endogenous melatonin production.
Methods- Data from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM.
- Patients received PRM nightly, followed by a 2-week withdrawal period.
- Main outcome measures were patient-reported sleep quality ratings (diary), adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]).
- Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM.
- Of the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment.
- The mean number of nights by which patients reported sleep quality as "good" or "very good" was significantly higher during PRM than before treatment.
- There was no evidence of tolerance to PRM.
- Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed.
- PRM was well tolerated, and there was no suppression of endogenous melatonin production.
