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Self-reported efficacy and tolerability of ramelteon 8 mg in older adults experiencing severe sleep-onset difficulty.
Am J Geriatr Pharmacother 2007; 5(3):177-84AJ

Abstract

BACKGROUND

Ramelteon is a selective MT(1)/MT(2) melatonin receptor agonist indicated for the treatment of insomnia characterized by difficulty with sleep onset.

OBJECTIVE

The current analysis was conducted to determine the effectiveness of ramelteon 8 mg in reducing the time to fall asleep in older adults with severe baseline sleep-onset difficulties.

METHODS

Patients with severe sleep-onset difficulty (defined as subjective sleep latency [sSL] > or =60 minutes) who had received ramelteon 8 mg or placebo were selected from a previously published multicenter outpatient trial of 829 older adults (aged > or =65 years) with primary, chronic insomnia (according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). Patients received single-blind placebo for 7 days (baseline) before receiving double-blind ramelteon 8 mg or placebo nightly for 5 weeks (35 nights). A 7-day, single-blind, placebo washout period followed. The primary end point was mean sSL for nights 1 through 7 (week 1). The mean changes in sSL from baseline at weeks 3 and 5 were evaluated to assess sustained efficacy. Adverse events (AEs) were collected in this analysis for both the ramelteon 8-mg and placebo groups.

RESULTS

A total of 157 patients from the rameltcon 8-mg group (mean age, 72.7 years; 87 women, 70 men) and 170 patients from the placebo group (mean age, 72.3 years; 111 women, 59 men) met the entry criteria for this post hoc analysis. Ramelteon 8 mg significantly reduced sSL at week 1 compared with placebo (change from baseline, -23.2 vs -7.5 minutes; P = 0.002). This statistically significant improvement was sustained at week 3 (-33.7 vs -19.8 minutes; P = 0.005) and week 5 (-37.4 vs -17.1 minutes; P < 0.001). The incidence of AEs was low. The most commonly reported treatment-emergent AEs were dizziness (ramclteon, 8.9%; placebo, 7.1%), dysgeusia (ramelteon, 7.0%; placebo, 2.9%), myalgia (ramelteon, 6.4%; placebo, 3.5%), and headache (ramelteon, 5.1%; placebo, 5.9%).

CONCLUSIONS

In this subset analysis of older adults with severe baseline sleep-onset difficulties, ramelteon 8 mg significantly and persistently reduced subjective reports of time to sleep onset during 5 weeks of nightly treatment. Ramelteon appeared to be an effective and well-tolerated treatment for these older adults with primary, chronic insomnia.

Authors+Show Affiliations

Takeda Pharmaceuticals North America, Inc., Deerfield, Illinois 60015, USA. lmini@tpna.comNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17996657

Citation

Mini, Louis J., et al. "Self-reported Efficacy and Tolerability of Ramelteon 8 Mg in Older Adults Experiencing Severe Sleep-onset Difficulty." The American Journal of Geriatric Pharmacotherapy, vol. 5, no. 3, 2007, pp. 177-84.
Mini LJ, Wang-Weigand S, Zhang J. Self-reported efficacy and tolerability of ramelteon 8 mg in older adults experiencing severe sleep-onset difficulty. Am J Geriatr Pharmacother. 2007;5(3):177-84.
Mini, L. J., Wang-Weigand, S., & Zhang, J. (2007). Self-reported efficacy and tolerability of ramelteon 8 mg in older adults experiencing severe sleep-onset difficulty. The American Journal of Geriatric Pharmacotherapy, 5(3), pp. 177-84.
Mini LJ, Wang-Weigand S, Zhang J. Self-reported Efficacy and Tolerability of Ramelteon 8 Mg in Older Adults Experiencing Severe Sleep-onset Difficulty. Am J Geriatr Pharmacother. 2007;5(3):177-84. PubMed PMID: 17996657.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Self-reported efficacy and tolerability of ramelteon 8 mg in older adults experiencing severe sleep-onset difficulty. AU - Mini,Louis J, AU - Wang-Weigand,Sherry, AU - Zhang,Jeff, PY - 2007/06/29/accepted PY - 2007/11/13/pubmed PY - 2008/1/23/medline PY - 2007/11/13/entrez SP - 177 EP - 84 JF - The American journal of geriatric pharmacotherapy JO - Am J Geriatr Pharmacother VL - 5 IS - 3 N2 - BACKGROUND: Ramelteon is a selective MT(1)/MT(2) melatonin receptor agonist indicated for the treatment of insomnia characterized by difficulty with sleep onset. OBJECTIVE: The current analysis was conducted to determine the effectiveness of ramelteon 8 mg in reducing the time to fall asleep in older adults with severe baseline sleep-onset difficulties. METHODS: Patients with severe sleep-onset difficulty (defined as subjective sleep latency [sSL] > or =60 minutes) who had received ramelteon 8 mg or placebo were selected from a previously published multicenter outpatient trial of 829 older adults (aged > or =65 years) with primary, chronic insomnia (according to Diagnostic and Statistical Manual of Mental Disorders [Fourth Edition, Text Revision] criteria). Patients received single-blind placebo for 7 days (baseline) before receiving double-blind ramelteon 8 mg or placebo nightly for 5 weeks (35 nights). A 7-day, single-blind, placebo washout period followed. The primary end point was mean sSL for nights 1 through 7 (week 1). The mean changes in sSL from baseline at weeks 3 and 5 were evaluated to assess sustained efficacy. Adverse events (AEs) were collected in this analysis for both the ramelteon 8-mg and placebo groups. RESULTS: A total of 157 patients from the rameltcon 8-mg group (mean age, 72.7 years; 87 women, 70 men) and 170 patients from the placebo group (mean age, 72.3 years; 111 women, 59 men) met the entry criteria for this post hoc analysis. Ramelteon 8 mg significantly reduced sSL at week 1 compared with placebo (change from baseline, -23.2 vs -7.5 minutes; P = 0.002). This statistically significant improvement was sustained at week 3 (-33.7 vs -19.8 minutes; P = 0.005) and week 5 (-37.4 vs -17.1 minutes; P < 0.001). The incidence of AEs was low. The most commonly reported treatment-emergent AEs were dizziness (ramclteon, 8.9%; placebo, 7.1%), dysgeusia (ramelteon, 7.0%; placebo, 2.9%), myalgia (ramelteon, 6.4%; placebo, 3.5%), and headache (ramelteon, 5.1%; placebo, 5.9%). CONCLUSIONS: In this subset analysis of older adults with severe baseline sleep-onset difficulties, ramelteon 8 mg significantly and persistently reduced subjective reports of time to sleep onset during 5 weeks of nightly treatment. Ramelteon appeared to be an effective and well-tolerated treatment for these older adults with primary, chronic insomnia. SN - 1543-5946 UR - https://www.unboundmedicine.com/medline/citation/17996657/Self_reported_efficacy_and_tolerability_of_ramelteon_8_mg_in_older_adults_experiencing_severe_sleep_onset_difficulty_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1543-5946(07)00045-1 DB - PRIME DP - Unbound Medicine ER -