JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
RESEARCH SUPPORT, N.I.H., EXTRAMURAL
RESEARCH SUPPORT, NON-U.S. GOV'T
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The sleep effects of lurasidone: a placebo-controlled cross-over study using a 4-h phase-advance model of transient insomnia.

BACKGROUND: Lurasidone, an atypical antipsychotic, is a potent 5-HT7 antagonist and D2 , 5-HT2A antagonist, and 5-HT1A partial agonist. As such, lurasidone would be expected to modulate sleep and circadian function but there have been no human studies of the sleep effects of a 5-HT7 antagonist. The purpose of this study was to assess effects of lurasidone on sleep.

METHODS: This was a cross-over, polysomnographic study involving 54 healthy volunteers who underwent two treatment periods (order randomized) each consisting of two nights in the laboratory: Night 1-lights out at usual bedtime; Night 2-4-h advance of sleep phase and randomization to either lurasidone 40 mg or placebo. The next morning impairment testing was carried out.

RESULTS: Lurasidone significantly (p < 0.05) increased total sleep time by an average of 28.4 min versus placebo, decreased wake time after sleep onset and wake time after the final awakening, and increased sleep efficiency. No other effects were found.

CONCLUSIONS: Lurasidone had a sleep maintenance effect without effects on sleep onset, rapid eye movement, or slow-wave sleep. Lurasidone is likely to be beneficial to patients with disturbed sleep, particularly those with sleep maintenance problems. Copyright © 2016 John Wiley & Sons, Ltd.

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