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Posttraumatic stress disorder (PTSD) affects about 77 million Americans, bringing with it disturbances that tend to severely affect sleeping patterns.
Current treatments for PTSD sufferers with sleep disturbances include anti-anxiety medications, like Zoloft or Paxil, and OTC sleep aids — both of which pose concerns for long-term efficacy and safety.
According to Dr. Seth Lederman, co-founder, CEO, and Chairman of TONIX Pharmaceuticals, a treatment involving cyclobenzaprine, a compound used as a muscle relaxant, may help PTSD sufferers get a good night's rest.
In addition to use as a muscle relaxant, cyclobenzaprine has an off-label use as a sleep aid for people with fibromyalgia, a condition that can mimic some symptoms of PTSD, such as anxiety, depression and insomnia.
TONIX is currently testing how sublingual cyclobenzaprine tablets at bedtime might help reduce pain and improve PTSD symptoms.
Poor sleep quality is a major concern for those with PTSD, but this issue has not yet been a target of FDA-approved treatments, notes Dr. Lederman.
"Whenever sleep is perceived as restful, patients report substantial improvement in their daytime symptoms," Dr. Lederman said. "So the key to truly effective treatment for PTSD or FM could lie in improving sleep quality."
Cyclobenzaprine sublingual tablets are quickly dissolved under the tongue, allowing the substance to be assimilated rapidly into the bloodstream as the patient begins to fall asleep.
Dr. Lederman says the drug has "no recognized addictive potential," as it would be relatively low-dose in nature. Upon waking, patients might experience slight grogginess.
According to the National Institutes of Health, common side effects of cyclobenzaprine can include drowsiness, dry mouth, dizziness, upset stomach and hair loss. More serious side effects that should elicit immediate medical attention may include irregular or rapid heartbeat, chest pain or sudden numbness on one side of the body.
Phase 2 trials of cyclobenzaprine and PTSD research are expected to take place late this year, with results likely to become available in 2014.
Source: TONIX Pharmaceuticals
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