The growing number of people who suffer from insufficient sleep is becoming a public health epidemic. Quality, duration, behaviors, and disorders associated with sleep, specifically the lack thereof, is becoming increasingly common.
Lifestyle habits, medications, hormones, illnesses, physical conditions, and daily stresses are catalysts to chronic insomnia – negatively influencing the biological mechanisms meant to put us out and keep us out for the ideal seven to eight hours a night.
Instead individuals suffer from sleeplessness – the inability to fall asleep and stay asleep. Often times a sleeping aid is employed to promote some type of rest, as prolonged periods of disturbed sleep or sleeplessness can have collateral effects on one’s overall well-being.
Federal regulators have recently reviewed an experimental insomnia drug called suvorexant, finding the sleep aid extremely effective in putting patients to sleep – turning off wakefulness by temporarily blocking the actions of orexins rather than just inducing sleep through traditional pharmacological means.
However, the US Food and Drug Administration (FDA) has found, when taken in high doses, suvorexant can significantly increase daytime somnolence and suicidal ideation – two things you certainly don’t want.
Therefore, the FDA is urging the distribution of the orexin receptor antagonist drug, manufactured by pharmaceutical powerhouse Merck & Co., be at much lower doses than initially formulated.
Orexin (hypocretin) is a neurotransmitter that regulates arousal and appetite, and promotes wakefulness. There is a limited number of neural cells that product orexin.
The neurotransmitter stimulates dopamine, norepinephrine, histamine and acetylcholine systems – playing an important role in stabilizing wakefulness and sleep.
The FDA stated the test trials showed suvorexant was better than a placebo at helping people fall asleep and stay asleep – finding the effectiveness consistent across several tested doses by Merck & Co. Inc. However patients taking higher doses had an eight-fold increase in daytime drowsiness, enough to impair driving.
Test subjects taking 20 milligrams and 40 milligrams of suvorexant had trouble staying in their driving lanes when studied by company researchers.
In addition, an association between suvorexant and suicidal thinking was established – as over a 12 month screening eight cases of suicidal behavior manifested among patients actually on the medication and not on a placebo.
Merck proposed a starting dose of 15 milligrams for seniors and 20 milligrams for non-seniors. Thereafter, doctors would gradually raise these doses to 30 milligrams and 40 milligrams, respectively, or until the patient’s insomnia has been successfully treated.
The FDA suggests, based on the data, that a 10 milligram dosage may be safer, while still being effective, and eliminating the higher dose options as they are not considered safe in their opinion.
“Indeed, if a dosage strength lower than 15 milligrams is unavailable, we would need to consider if the drug could be marketed safely at all, if we believe that a substantial proportion of the indicated population needs a lower dose,” the agency stated in its review.
It could take Merck 18 months to resubmit its drug for review if the FDA requires another study of low-dose suvorexant. The drug, once approved, is projected to generate $650 million by 2018.
Recently the FDA also implored the makers of Ambien to do the same – lessening the intended nighttime doses as it was found remnants of the sedative lingered in the bloodstream for prolonged periods after waking, resulting in drowsy driving.
The FDA recommended doses for women be cut in half, from 10 milligrams to 5 milligrams for immediate-release products (Ambien, Edluar, and Zolpimist) and from 12.5 mg to 6.25 mg for extended-release products (Ambien CR).
For men, the agency has asked manufacturers to change the labeling to recommend that doctors and other health-care professionals consider prescribing lower doses, meaning 5 mg for immediate-release products and 6.25 mg for extended-release products.
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FDA Review Of Suvorexant, New Sleeping Pill is a post from: The Inquisitr