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Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal
BACKGROUND: Prolonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinu...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove Medical Press
2011
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3150476/ https://www.ncbi.nlm.nih.gov/pubmed/21845053 http://dx.doi.org/10.2147/TCRM.S23036 |
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author | Lemoine, Patrick Garfinkel, Doron Laudon, Moshe Nir, Tali Zisapel, Nava |
author_facet | Lemoine, Patrick Garfinkel, Doron Laudon, Moshe Nir, Tali Zisapel, Nava |
author_sort | Lemoine, Patrick |
collection | PubMed |
description | BACKGROUND: Prolonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation. OBJECTIVE: To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment. 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. RESULTS: 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. CONCLUSION: 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. |
format | Online Article Text |
id | pubmed-3150476 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2011 |
publisher | Dove Medical Press |
record_format | MEDLINE/PubMed |
spelling | pubmed-31504762011-08-15 Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal Lemoine, Patrick Garfinkel, Doron Laudon, Moshe Nir, Tali Zisapel, Nava Ther Clin Risk Manag Original Research BACKGROUND: Prolonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation. OBJECTIVE: To investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment. 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. RESULTS: 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. CONCLUSION: 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. Dove Medical Press 2011 2011-07-26 /pmc/articles/PMC3150476/ /pubmed/21845053 http://dx.doi.org/10.2147/TCRM.S23036 Text en © 2011 Lemoine et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. |
spellingShingle | Original Research Lemoine, Patrick Garfinkel, Doron Laudon, Moshe Nir, Tali Zisapel, Nava Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
title | Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
title_full | Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
title_fullStr | Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
title_full_unstemmed | Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
title_short | Prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
title_sort | prolonged-release melatonin for insomnia – an open-label long-term study of efficacy, safety, and withdrawal |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3150476/ https://www.ncbi.nlm.nih.gov/pubmed/21845053 http://dx.doi.org/10.2147/TCRM.S23036 |
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