کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
3176398 1200265 2011 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Long-term safety and efficacy of ramelteon in Japanese patients with chronic insomnia
موضوعات مرتبط
علوم زیستی و بیوفناوری علم عصب شناسی عصب شناسی
پیش نمایش صفحه اول مقاله
Long-term safety and efficacy of ramelteon in Japanese patients with chronic insomnia
چکیده انگلیسی

ObjectiveTo evaluate the safety of ramelteon, a highly selective MT1/MT2 melatonin receptor agonist, during 24 weeks’ treatment of Japanese patients with chronic insomnia.MethodsIn a single-blind, flexible-titration, multicenter study incorporating placebo run-in and run-out periods, 190 adults with chronic insomnia received ramelteon 4 or 8 mg, titrated up to 16 mg if necessary, for 24 weeks. Primary endpoints included adverse events, residual effects, rebound insomnia, withdrawal symptoms, and dependence. Secondary endpoints included subjective sleep latency and total sleep time.ResultsDrug-related adverse events occurred in 11.6% of patients. No clinically important changes occurred in biochemical, hematological or endocrine parameters. There were no signs of next-day residual effect, rebound insomnia, withdrawal symptoms or dependence. Mean subjective sleep latency decreased significantly, and total sleep time increased significantly; both reached a plateau by week 20 and were sustained thereafter (P < 0.0001).ConclusionsRamelteon was well tolerated in adult Japanese patients with chronic insomnia and did not cause deterioration of efficacy, residual effects, rebound insomnia, withdrawal symptoms, or dependence after 24 weeks’ treatment.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Sleep Medicine - Volume 12, Issue 2, February 2011, Pages 127–133
نویسندگان
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