You may have noticed that cannabidiol (CBD) seems to be available almost everywhere, and marketed as a variety of products including drugs, food, dietary supplements, cosmetics, and animal health products. Other than one prescription drug product to treat seizures associated with Lennox Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in people one year of age and older, the U.S. Food and Drug Administration (FDA) has not approved any other CBD products, and there is very limited available information about CBD, including about its effects on the body.
CBD products are also being marketed for pets and other animals. The FDA has not approved CBD for any use in animals and the concerns regarding CBD products with unproven medical claims and of unknown quality equally apply to CBD products marketed for animals. The FDA recommends pet owners talk with their veterinarians about appropriate treatment options for their pets.
Potential harm, side effects and unknowns
The FDA is evaluating the regulatory frameworks that apply to certain cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations, as well as whether potential legislation might be appropriate. The information we have underscores the need for further study and high quality, scientific information about the safety and potential uses of CBD.
Misleading, unproven, or false claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment, and supportive care. For that reason, it’s important to talk to your doctor about the best way to treat diseases or conditions with available FDA-approved treatment options.
The FDA is committed to setting sound, science-based policy. The FDA is raising these safety, marketing, and labeling concerns because we want you to know what we know. We encourage consumers to think carefully before exposing themselves, their family, or their pets, to any product, especially products like CBD, which may have potential risks, be of unknown quality, and have unproven benefits.
Sleep can be disrupted for many reasons, including depression. Rodents seemed to adapt better to stressful conditions and exhibited less depressive-like behavior after taking CBD, according to a review in Journal of Chemical Neuroanatomy. “Surprisingly, CBD seems to act faster than conventional antidepressants,” wrote one of the authors of a new review, Sâmia Joca, a fellow at the Aarhus Institute of Advanced Studies in Denmark and an associate professor at the University of São Paulo in Brazil, in an email interview. Of course, it’s difficult to detect depression in animals, but the studies that Ms. Joca and her colleagues reviewed suggested that in models of chronic stress exposure, the mice and rats treated with CBD were more resilient.
Earlier research found fewer than a third of 84 products studied contained the amount of CBD on their labels. Some users of CBD have also failed drug tests when the product contained more THC than indicated.
But he cautions that the side effects could have been because of an interaction with other medications the children were taking to control the seizures. So far, there hasn’t been a randomized, placebo-controlled, double-blind trial (the gold standard) on sleep disorders and CBD.
Tips for Better Sleep
Cannabidiol, or CBD, is the lesser-known child of the cannabis sativa plant; its more famous sibling, tetrahydrocannabinol, or THC, is the active ingredient in pot that catapults users’ “high.” With roots in Central Asia, the plant is believed to have been first used medicinally — or for rituals — around 750 B.C., though there are other estimates too.
But without clinical trials in humans, psychologists say CBD’s effect on depression is still a hypothesis, and not an evidence-based treatment.
Dr. Smita Das, chair of the American Psychiatric Association’s Council on Addiction Psychiatry’s cannabis work group, does not recommend CBD for anxiety, PTSD, sleep or depression. With patients turning to these to unproven products, she is worried that they may delay seeking appropriate mental health care: “I’m dually concerned with how exposure to CBD products can lead somebody into continuing to cannabis products.”
Last year, the F.D.A. approved Epidiolex, a purified CBD extract, to treat rare seizure disorders in patients 2 years or older after three randomized, double-blind and placebo-controlled clinical trials with 516 patients that showed the drug, taken along with other medications, helped to reduce seizures. These types of studies are the gold standard in medicine, in which participants are divided by chance, and neither the subject nor the investigator knows which group is taking the placebo or the medication.
For example, some human clinical trials suggest that CBD could be effective in treating symptoms of anxiety, particularly social anxiety, Bonn-Miller said.
Seventeen additional states have CBD-specific laws on the books, according to Prevention magazine. Those are Alabama, Georgia, Indiana, Iowa, Kentucky, Mississippi, Missouri, North Carolina, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin and Wyoming.
And Welty said the studies that have featured humans for these other CBD uses have either been case reports or studies that did not compare results against a control group that did not use the oil.
Worse, about 1 in 5 CBD products contained the intoxicating pot chemical THC, Bonn-Miller and his colleagues found.
“There’s no control, so it’s basically how do you know if we’re dealing with the true effect of the drug or just simply a placebo effect because somebody thinks they’ve been given a drug that will be beneficial?” Welty said.