30th November 2012 - An experimental new sleep medication helps insomniacs fall asleep faster and stay asleep longer, early data suggests.
Studies reported at a sleep conference last June confirmed the findings about Merck’s suvorexant, says Dr Joseph Herring, the company’s executive director for clinical neuroscience. Those studies are not yet published, but they form part of Merck's evidence to win approval for the drug.
"What we've seen here and confirmed in [the later studies] is that suvorexant helps people with insomnia fall asleep faster and wake less," Dr Herring, who led the published study, tells us. "It is effective over the long term and well tolerated."
The published study tested whether a range of doses, each given in a sleep lab to about 60 people suffering from insomnia, improved sleep better than an inactive placebo pill. Without knowing which was which, each study participant took either suvorexant or the placebo for four weeks, then switched to the other for another four weeks.
The main study measure was sleep efficiency -- that is, the percentage of an eight-hour night people slept. At the beginning of the study, participants’ average sleep efficiency was 66%. After falling asleep, they woke for an average 101 minutes during the night.
"There was a range of results, but generally sleep efficiency improved 5% to 13% compared to placebo," Dr Herring says. "We also found that patients have 21 to 37 minutes less time awake during the night." Suvorexant doesn't work like other sleeping pills. Current sleep drugs enhance brain functions that increase sleepiness. Suvorexant inhibits orexin, also known as hypocretin, a hormone that acts on the brain to increase wakefulness. Brain levels of orexin are naturally lower during the night.
Professor Adrian Williams, professor of sleep medicine at King's College, London tells us in an email that the findings are "biologically plausible given the wake-promoting central actions of Orexin/Hypocretin" which is "the 'switch' that takes us from sleep to wake".
He says suvorexant appears to fulfil the role of a truly novel agent and that early indications that it has few side effects are encouraging.
The latest study appears in the 4th December issue of the journal Neurology. The study was funded and performed by Merck.
Herring, W.J. Neurology, Dec. 4, 2012.
William Joseph Herring, MD, PhD, executive director for clinical neuroscience, Merck Research Laboratories, North Wales, Pa.
Professor Adrian Williams, professor of sleep medicine, King's College, London.
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