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Title of Journal: Sleep Breath

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Abbravation: Sleep and Breathing

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Springer-Verlag

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ISSN

1522-1709

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Safety of ramelteon in individuals with mild to mo

Authors: Meir Kryger Sherry WangWeigand Thomas Roth
Publish Date: 2007/02/10
Volume: 11, Issue: 3, Pages: 159-164
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Abstract

Ramelteon is a selective MT1/MT2receptor agonist indicated for insomnia treatment Because it has no depressant effects on the nervous system it is not expected to affect the control of breathing The potential effects of ramelteon on apneic and hypopneic events and arterial oxygen saturation SaO2 in individuals with obstructive sleep apnea were assessed In this doubleblind randomized crossover study 26 adults with mild to moderate obstructive sleep apnea received ramelteon 16 mg and placebo for one night each with a 5 to 12day washout period between treatments Treatments were administered 30 min before habitual bedtime Respiratory effort was monitored using respiratory inductance plethysmography SaO2 was measured by pulse oximetry and sleep onset and duration were measured by polysomnography and postsleep questionnaire Postsleep questionnaire also measured nextday residual effects The primary measure was apnea–hypopnea index Apnea–hypopnea index was similar in ramelteon and placebo groups 114 vs 111 respectively CI = −21 26 P = 0812 Ramelteon had no effect on the number of central obstructive or mixed apnea episodes No significant differences were observed in SaO2 for the entire night between ramelteon and placebo 951 vs 947 P = 0070 Ramelteon did not meaningfully affect sleep when evaluated by polysomnography and postsleep questionnaire Compared with placebo ramelteon had no significant effect on nextday residual effects Adverse events were reported by three subjects in the ramelteon group headache n = 2 and urinary tract infection n = 1 No adverse events were reported with placebo Ramelteon was welltolerated and as expected did not worsen sleep apnea when administered to subjects with mild to moderate obstructive sleep apnea


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