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Many people use cannabis as a sleep aid, but does it really work? We review the emerging research on cannabis for sleep, including benefits and side effects. From CBD oil tinctures and capsules to bath bombs, we review the best CBD products online to help you relax and sleep quickly and naturally. The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

Using Cannabis As A Sleep Aid

We regularly assess how the content in this article aligns with current scientific literature and expert recommendations in order to provide the most up-to-date research.

Medical Disclaimer: The content on this page should not be taken as medical advice or used as a recommendation for any specific medication. Always consult your doctor before taking any new medication or changing your current dosage.

Cannabis, also called marijuana, is widely used as a sleep aid, both recreationally and among medical users. Around 70% of young adults that casually use cannabis report that they do so to help them sleep. Among long-term cannabis users (those who have been using it for 10 years or more), about half use cannabis to improve their sleep. Among people who use cannabis for medical reasons, such as pain relief, as many as 85% say it improves their sleep.

Research into cannabis as a sleep aid is still developing. Cannabis may help relieve insomnia when used occasionally, though researchers are unsure whether long-term use is ultimately beneficial or detrimental for sleep quality.

Does Cannabis Help You Sleep?

Cannabis appears to improve sleep in certain cases. For people with certain conditions such as chronic pain, post-traumatic stress disorder (PTSD), and multiple sclerosis, cannabis may help them fall asleep faster, wake up less during the night, and enjoy better sleep quality overall. A recent study also found that cannabis effectively relieves symptoms for people with restless legs syndrome (RLS).

Many people use cannabis to self-treat insomnia, anxiety, and pain. Among these users, the effectiveness of cannabis for sleep is more ambivalent, though a study conducted on individuals with insomnia found that many participants reported relief from their symptoms when using cannabis.

Some studies have found a distinction between daily users and less frequent, non-daily users in how cannabis affects their sleep. Those who use cannabis daily are more likely to report more sleep problems than occasional users or people who do not use cannabis at all. Non-daily users report fewer sleep issues than both daily users and non-users.

How Does Cannabis Work as a Sleep Aid?

It is believed that the sleep-promoting effects of cannabinoids are due to their interactions with cannabinoid receptors in the brain. When cannabinoids bind to these receptors, they send messages to increase levels of sleep-promoting adenosine levels and suppress the brain’s arousal system. Together, these effects may help cannabis users feel sedated or sleepy.

Cannabis has several different active compounds, including tetrahydrocannabinol (THC) and cannabidiol (CBD). While THC typically acts as a sedative, it can have a stimulating effect for some people, especially for those who are new to using cannabis or taking higher doses. In these cases, using cannabis before bed may result in a longer time falling asleep. CBD appears to promote alertness at lower doses, and sleepiness at higher doses. The effects of the two compounds together may depend on the dose and timing.

Both CBD and THC may also have benefits for chronic conditions that interfere with sleep.

For example, synthetic forms of THC have shown potential for treating obstructive sleep apnea, reducing PTSD-related nightmares, and improving sleep for people living with chronic pain. CBD, on the other hand, may reduce symptoms of REM sleep behavior disorder and excessive daytime sleepiness.

When using cannabis as a sleep aid, the effects you feel may depend on the type of cannabis you are using. Cannabis has higher concentrations of THC, the primary psychoactive component. Hemp plants have higher levels of CBD.

Does Cannabis Affect Your Sleep Quality?

In addition to helping you fall asleep faster, cannabis may alter your sleep architecture, a term that describes how long you spend in the different sleep stages. Short-term cannabis use appears to increase the time you spend in deep sleep, the stage that helps you wake up feeling refreshed. However, THC decreases the amount of time you spend in rapid eye movement (REM) sleep, when you spend more time dreaming, processing emotions, and cementing new memories.

Decreasing REM sleep may have some benefits for people with PTSD, since nightmares are a common and disturbing symptom. A study on women with PTSD found that those with more severe PTSD symptoms and poor sleep were more likely to use cannabis to help them cope. One study found that synthetic forms of cannabis significantly decreased nightmares, or stopped them completely, for people with PTSD. Some participants in this study also reported experiencing better overall sleep quality and fewer daytime flashbacks.

How Is Cannabis Different from Other Natural Sleep Aids?

Because cannabis is considered a controlled substance, there is limited research on the safety and efficacy of cannabis sleep aids compared to other sleep aids. Only a few synthetic drugs made to mimic THC, as well as one naturally derived CBD product, have been approved by the FDA. These are prescribed for nausea and other conditions, but not sleep.

As with other natural sleep aids, it is possible that some people may turn to medical cannabis in an effort to avoid more potent drugs, such as opioids. Although they can be very effective in the short term, many prescription and over-the-counter sleep medications are associated with a risk of abuse, tolerance, or dependence. Some natural sleep aids, like oral melatonin, appear to reduce insomnia without strong side effects, while other homeopathic options, like valerian, still need more research.

Which Type of Cannabis is Best For Sleep?

There are different strains of cannabis, which each produce different effects. The most common strains are indica and sativa:

  • Indica is thought to be more calming, and may help produce feelings of relaxation and sleepiness. People appear to prefer indica for pain management, relaxation, and sleep.
  • Sativa is considered more stimulating, and it may produce feelings of euphoria for some. People tend to use sativa to gain an energy boost.

Due to its relaxing effects, indica may be considered the best cannabis strain for sleep. However, individuals who use cannabis to avoid nightmares may prefer sativa. Hybrid strains with a mix of indica and sativa may produce different effects based on the specific makeup of cannabinoids and other ingredients.

Most of the differences attributed to sativa versus indica strains are based on the subjective experiences of cannabis users. Some researchers argue that the distinction between indica and sativa strains is less relevant than the variety in THC content and other ingredients in any particular product.

Risks and Side Effects of Using Cannabis for Sleep

Used on a short-term basis, cannabis may help you fall asleep faster. Health experts generally do not recommend using sleep aids, including cannabis, on a long-term basis, because of their potential to negatively impact your sleep quality and cause other side effects.

Studies suggest that people who use cannabis as a long-term sleep aid tend to develop a tolerance to its sedative effects, and may need to take more to obtain the same results. Heavy cannabis use, especially on a long-term basis, may have consequences for sleep, including:

  • Less sleep overall
  • Less time spent in deep sleep
  • Longer time to fall asleep
  • Frequent awakenings

One study found high doses of THC at night can lead to unwanted side effects the following day, such as impaired memory and sleepiness. Cannabis withdrawal can also produce sleep-related side effects, such as strange dreams, difficulty falling asleep, and less time spent in deep sleep.

Long-term cannabis use may also have health-related side effects. Studies have found the substance may reduce the volume of gray matter in your brain and, when smoked, increase your risk of chronic bronchitis. Health experts also recommend people avoid using cannabis while pregnant or breastfeeding.

Tips When Using Cannabis for Sleep

If you plan on trying cannabis as a sleep aid, your care provider can provide the best guidance based on your needs and medical history. However, it helps to have an understanding of the different options available.

What Form of Cannabis to Use for Sleep

Cannabis can be smoked, vaporized, eaten, or placed under the tongue as a sublingual tincture. Each format has different benefits and drawbacks. Those who are concerned about the effects of smoke on the lungs may prefer to avoid smoking it.

Different forms of cannabis offer different bioavailability, or how much of the active THC you can expect to make it into your bloodstream. Inhaled cannabis tends to have high bioavailability, as the THC enters your system directly. By contrast, edibles lose a significant amount of THC through the digestive process. Smoked cannabis can have bioavailability rates as high as 56%, compared with 4% to 20% for orally ingested cannabis.

When to Take Cannabis for Sleep

When choosing a type of cannabis, it is worth noting that different forms also take more or less time to produce effects. When you smoke cannabis, you can generally feel the effects almost immediately, whereas edibles can take longer to have an effect as they must work their way through your digestive system first.

The effects of smoked cannabis are highly variable depending on the person, the length of inhalation, the number of times it is inhaled, and other factors. It may be helpful to know that THC levels generally peak after about 10 minutes.

What Effects You May Notice

Because cannabis comes in a variety of strains and affects everyone differently, you may need to experiment before you find the format, dosage, and timing that work for you. THC is a psychoactive drug that tends to have other effects apart from promoting sleep. You may feel sleepy, relaxed, euphoric, or energized.

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When using cannabinoids, some users may also experience dizziness, nausea, fatigue, dry mouth, vomiting, confusion, loss of balance, or hallucinations. You may also experience anxiety, panic attacks, or paranoia.

Using cannabis may not be a good idea for children and adolescents, as cannabis use has been linked to changes in the developing brain.

Deciding If Cannabis Is Right for You

Whether or not to use cannabis for sleep is a highly personal decision. Synthetic forms of cannabis appear to relieve nightmares and insomnia, but some researchers warn about the limitations of these studies and the potential risks of using cannabis until dosing is more standardized.

Many people use cannabis to successfully manage their pain and insomnia. However, some people find it makes them feel more paranoid or anxious. If you do not like the feeling of being high, a strain with a higher amount of CBD may be a better option for you.

Another important consideration is whether cannabis is legal where you live. If not, talk to your doctor about other ways to improve your sleep, such as better sleep hygiene or alternative sleep aids.

RS Recommends: How Do These CBD Products Help With Sleep?

If you purchase an independently reviewed product or service through a link on our website, Rolling Stone may receive an affiliate commission.

Everyone is trying to get better sleep today and there are no shortage of products that promise to help ease you into deeper slumber, from weighted blankets to fancy sound machines. But more and more people are adding CBD to their sleep checklist as well.

When Travis Barker had trouble falling asleep on tour, after a grueling schedule had him in a different city and different bed each night, the drummer started to look for more “natural ways to wind down.” That’s when he discovered CBD.

“I used to have trouble with sleep,” Barker tells Rolling Stone, “and I would take a ton of melatonin, valerian tea, Tylenol PM, or Nyquil,” he admits, “but CBD was like the best kind of result that I got.”

The immediate benefits that Barker found with CBD led him to create Barker Wellness, a new line of cannabinoid-infused products that includes a unique CBD tincture for sleep. While CBD is not a medically-approved solution for sleep, experts say a little CBD could go a long towards promoting more soothing, stress-free slumber.

How Does CBD Work for Sleep?

“CBD is a compound that supports a powerful, yet widespread network of receptors in the body called the endocannabinoid system (ECS), which is known to help regulate energy, mood, sleep, and more,” explains Dr. Jason Wersland, Founder and Chief Wellness Officer of Therabody, the newly-rebranded company that now includes the popular Theragun percussion devices as well as a line of lotions and tinctures for recovery and relief. “Researchers have found that CBD, found naturally in the hemp plant, interacts with ECS receptors throughout the body much like molecules the body naturally produces.”

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Experts say the best CBD products for sleep also help you wind down by addressing some of the root causes of restlessness and stress.

“Most people don’t realize the quality of sleep is closely related to stress and maintaining a strong immune system, and you need both systems properly in check if you want an optimal immune response to anything,” adds Jay Hartenbach, CEO of CBD brand Medterra. “If your cortisol levels are elevated, it can keep you awake. CBD is thought to decrease this and keep your body in a homeostasis state.”

If you’re just easing into CBD, Hartenbach suggests finding CBD products that also contain other ingredients that work together to help you feel more restful and relaxed. “CBD, amino acids, L-theanine and 5-HTP, and relaxing herbs like passion flower, chamomile, and lemon balm have each individually been shown to help with providing a full restful night and have been expertly formulated to work together for desired results to address the most common issues,” Hartenbach says. “Proper sleep and circadian control are absolutely essential to an optimally functioning immune system. If your body lacks restful sleep, so does your immunity.”

Will CBD for Sleep Make You Drowsy or High?

The best CBD for sleep is designed to help you ease into slumber — not knock you out. And unlike THC, which may have some psychoactive effects, Wersland says “CBD is non-intoxicating and will not make you feel high.”

If you’re new to CBD, trying a CBD gummy for sleep is an easy way to test out its effects in an easy-to-take format (basically like a gummy bear or gummy vitamin). Many brands also have flavorless CBD oils (or “CBD tinctures”), which come out of a dropper, letting you control exactly how much you want to take. Wersland’s suggestion: start small and then see how the tincture affects you. “If you’d like to take one full dropper that’s 33mg of full-spectrum CBD you can,” he says, “or you can take a ¼ of a dropper which is about 8mg of CBD.”

Of course CBD is primarily meant for therapeutic benefits and is not meant to replace any doctor-recommended prescriptions if you suffer from serious insomnia. You should also see a doctor if you have a severe sleep disorder, restlessness or anxiety, as CBD is not meant to treat those issues.

What is the Best CBD for Sleep?

If you’re looking to try out CBD products for sleep, we’re rounded up some of our favorite options below. These have all been tested by our editors for ease of use and efficacy, though CBD will affect everyone differently. All the products on our list have also been tested by independent third-party labs for quality assurance and safety but you should read the ingredient list and labels before using to find the right products for your needs.

1. evn Sleep Powder

If you’re used to a warm drink before bed to calm you down, evn’s Sleep Powder will help you ease your way into some Zzz’s. Each serving (about a spoonful) contains 20mg of full spectrum CBD which you blend into milk (of any kind), tea or hot water about 30 minutes before you go to bed.

Not only is the hemp organically-sourced and lab-tested, but the powder also has a “sleep-enhancing” blend of magnesium, passionflower, L-theanine, melatonin, vitamins, and minerals to give you a deeper sleep that you wake up from feeling refreshed instead of zonked. If you don’t want the “grassy” taste of a CBD oil right before you knock out, evn’s Sleep Powder has a pleasant cocoa flavor that tastes more like a pre-bed treat than a medicinal tincture. While it can take have an effective boost to your sleep quality after one night, evn recommends trying it for 2-3 nights to get the best rest possible.

BONUS: Use coupon code ROLLINGSTONE20 for 20% off your order at Evn-CBD.com.

2. Cornbread Hemp AM/PM CBD Oil Bundle

One of the easiest ways to get into CBD is with this AM/PM CBD oil bundle from Cornbread Hemp. Take a drop or two of the Distilled CBD Oil in the morning to start your day, and chill out at night with the Whole Flower CBD Oil. To use: place a few drops under your tongue and hold for 30 seconds before swallowing, or mix a few drops into a glass of water or your bedtime tea (it’s virtually tasteless and it dissolves easily).

Cornbread uses only USDA-certified organic ingredients, with no preservatives, flavors or sweeteners. Choose from an original strength or extra strength pack. What we like: the included dropper has four size markings (0.25, 0.50, 0.75 and 1ml) so you can easily control your dosage and work your way up (for reference, one serving is 1ml).

BONUS: Use coupon code RS20 for 20% off your purchase at CornbreadHemp.com.

3. Prima Sleep Tight Soft Gels

Take one or two of these Prime Soft Gels before bed each night as part of your wind down routine. In our experience, the easy-to-swallow capsules have worked wonders in helping us fall asleep faster — and stay asleep without waking up in the middle of the night.

While other CBD blends for sleep use melatonin to help you doze off, Prima’s formula is melatonin-free, swapping the popular sleep aid for other natural remedies, like the amino acid compounds 5-HTP and GABA (which promote relaxation and mood enhancement), plus natural herbs like passion flower, California poppy and lavender to help calm and sedate without the need for a prescription.

We woke up feeling less groggy too and the CBD capsules don’t give you that intoxicated feeling you get from cheaper generic CBD brands.

4. Sunday Scaries “Side Piece” Bundle

If you’ve been feeling overwhelmed by all the CBD choices out there, Sunday Scaries’ “Side Piece” bundle is one of the easiest and least intimidating ways to get into a CBD routine. The bundle includes a bottle of fruit-flavored CBD gummies for when you want to chill out, and then a bottle of CBD oil for sleep. Typically $98 when you buy each item separately, the bundle gets you both for just $43 right now (a $55 savings).

Aside from being an incredible value, both the gummies and tincture have rave reviews online. Start with one gummy (10mg of CBD) after work, while you’re watching a movie, or when you want to zone out while doing chores or housework on the weekend. The CBD tincture, meantime, can go directly under the tongue, or in your tea, water, mixed into a smoothie or even mixed into your favorite lotion. Sunday Scaries also recommends trying a few drops of the CBD oil in your bath to help you relax. One bottle for the day and one bottle for night – your CBD routine just got a whole lot easier.

5. Charlotte’s Web CBD Gummies: Sleep

We’re big fans of these raspberry-flavored CBD gummies from Charlotte’s Web, which has helped us ease into sleep with less tossing and turning (or anxious thoughts). Each gummy contains 10mg of CBD, along with other natural sleep aids like 3mg of melatonin. We’ve found that these work fast, so take them just before bed (like 15-20 minutes before you hit the sack).

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Each pack contains 30 servings. Not sure how your body will react? We started by taking half a gummy, before slowly graduating to taking the full piece.

6. Terravita Sleep CBD Capsules

If you prefer the ease of a capsule, we like Terravita’s Sleep CBD Capsules. These easy-to-swallow capsules include a broad spectrum hemp extract that contains 30mg of broad spectrum CBD (that’s also THC-free).

In addition to the hemp extracts, these capsules contain natural ingredients like L-Theanine (for stress), Valerian root (to fall asleep faster), melatonin (to help regulate the sleep cycle) and chamomile (which helps you get deeper sleep). Because this comes in a capsule format (rather than say, an edible or tincture), it can be great if you’re looking for a natural sleep aid, but hate the “grassy” flavor of traditional gummies.

Each order gets you 15 capsules. Take one at night about 30-45 minutes before bed. You can increase dosage to two capsules per day if you need something stronger.

7. Barker Wellness Sleep Tincture

Travis Barker’s new CBD line includes this easy-to-take sleep tincture. The unique formula combines CBD and CBN (another naturally occurring cannabinol said to help with insomnia), along with melatonin and gamma-aminobutyric acid (GABA), an amino acid believed to have stress-relieving properties. Take half a dropper to start and put it under your tongue or dissolve the drops into water. In our experience, we’ve found that a full drop under the tongue works best, though it takes an hour or so before you start feeling sleepy, so time it accordingly.

8. Zolt “Dreamy” Drink Mix

Nothing helps you unwind and get ready for bed quite like a hot, soothing drink, which is why we like these “Dreamy Mixie Sticks” from Zolt. Essentially a drink mix with CBD, each individually-wrapped pack contains 20mg of Kentucky-grown hemp, 3mg of melatonin and adaptogens (think aswagandha to help you de-stress). Natural honey, lemon and orange gives this a light citrusy flavor.

To use: pour one stick into about 8oz. of water. We like taking it with hot water about 20-30 minutes before bed. Prefer a more refreshing treat before you sleep? The Zolt drink mix blends easily into cold water too.

9. TheraOne Sleep CBD Tincture

Another easy-to-take CBD product that actually helps with sleep, from our experience, is the TheraOne Sleep CBD Tincture. Along with USDA-certified organic CBD, the TheraOne tincture also contains organic lavender, organic
lemon balm oil and organic chamomile, which the company says is “designed to help encourage deeper, more restorative sleep.”

TheraOne also touts its unique “Biosorb technology,” which it says can help increase the effectiveness of the CBD, so you can fall asleep faster — and stay sleeping more soundly.

To use: take one full dropper under the tongue, which delivers 33mg of CBD. You can also start with half a dropper to see how the formula affects you. Each bottle contains about 30 full servings.

Want the full-body experience? Get Therabody’s exclusive “Better Sleep Set,” which includes the Theragun Elite Smart Percussive Therapy device (a.k.a. a massage gun), soothing CBD Massage Oil, and a bottle of the TheraOne Sleep CBD Tincture. This all-in-one set is available for $574 at Theragun.com. It makes a great gift idea too.

10. CBDFX CBD Gummies with Melatonin for Sleep

These CBD gummies are the easiest options on our list to take, and the least-intimidating way to get into CBD for sleep. Take two of these gummies 30 minutes before bed for best effects. The lemon-flavored chews combine CBD with melatonin, which is a natural sleep aid. The company says the addition of magnesium helps to promote calmness.

Each serving of two gummies contains 50mg of broad spectrum CBD. Everything is certified vegan, all-natural and gluten-free, so it’s easy on the stomach too. A bonus: they actually taste pretty good too.

11. cbdMD Bath Bombs

A relaxing bath is always a good way to destress before bed, and many companies are now making CBD bath bombs for sleep. This one, from cbdMD, is made from a mix of USA-sourced hemp CBD and calming essential oils like frankincense, lavender, eucalyptus. The addition of epsom salts adds further restorative benefits.

This multi-pack contains six bath bombs in different colors and scents. Get 100mg of CBD per bath bomb. The effects of this are mild, so you’ll want to throw the entire CBD bomb in the water and let it slowly dissolve.

12. Terravita Sleep Better Bundle

Get the benefits of a bath and an ingestible with this Sleep Better Bundle from Terravita. The premium CBD company is known for their unique and potent formulas, which combine full-spectrum CBD with plant-based ingredients (think coconut oil, lavender oil and aloe vera in the bath soak, and hempseed oil and grapefruit in the tincture).

This set gets you a CBD bath soak to help with relaxation and recovery after a long day; a sleep CBD tincture to help you wind down; and a bottle of sleep CBD capsules that the company says promotes better sleep.

Use each item separately or as part of your nightly wellness routine. You’ll want to start with 3-4 scoops of the CBD bath soak and let it dissolve in warm water before getting in the bath. We like using it after a workout or travel, to help detox the body. For the tincture, take one full dropper and hold under your tongue for 30-60 seconds. The recommended dosage for the capsules, meantime, is one capsule, about 30-45 minutes before bed.

13. NuLeaf Naturals Full-Spectrum CBN Oil

Colorado-based NuLeaf Naturals makes some of the most straight-forward and fast-acting CBD products on the market, with easy-to-take formulas that promise to help clear your mind and prepare your body for sleep. We like their full-spectrum CBN oil, which uses CBN, another cannabinoid in the cannabis plant that is said to have sleep benefits. While some CBD can have energizing effects, researchers have found that CBN is used more as a natural sedative.

This bottle contains 60 servings of CBN oil – about 30mg per dropper. Start with half a dropper to see if you feel sleepy; gradually increase to a full dropper for maximum effect.

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

  • Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.
  • Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.
  • The FDA has approved only one CBD product, a 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.
  • It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.
  • The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.
  • Some CBD products are being marketed with unproven medical claims and are of unknown quality.
  • The FDA will continue to update the public as it learns more about CBD.

Potential harm, side effects and unknowns

  1. CBD has the potential to harm you, and harm can happen even before you become aware of it.
    • CBD can cause liver injury.
    • CBD can affect how other drugs you are taking work, potentially causing serious side effects.
    • Use of CBD with alcohol or other drugs that slow brain activity, such as those used to treat anxiety, panic, stress, or sleep disorders, increases the risk of sedation and drowsiness, which can lead to injuries.
    • Male reproductive toxicity, or damage to fertility in males or male offspring of women who have been exposed, has been reported in studies of animals exposed to CBD.
  2. CBD can cause side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced.
    • Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).
    • Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.
    • Changes in mood, most commonly experienced as irritability and agitation.
  3. There are many important aspects about CBD that we just don’t know, such as:
    • What happens if you take CBD daily for sustained periods of time?
    • What level of intake triggers the known risks associated with CBD?
    • How do different methods of consumption affect intake (e.g., oral consumption, topical , smoking or vaping)?
    • What is the effect of CBD on the developing brain (such as on children who take CBD)?
    • What are the effects of CBD on the developing fetus or breastfed newborn?
    • How does CBD interact with herbs and other plant materials?
    • Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

Unanswered questions about the science, safety, and quality

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.

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The FDA recognizes the significant public interest in cannabis and cannabis-derived compounds, particularly CBD. However, there are many unanswered questions about the science, safety, and quality of products containing CBD. The agency is working on answering these questions through ongoing efforts including feedback from a recent FDA hearing and information and data gathering through a public docket.

Despite the 2018 Farm Bill removing hemp — defined as cannabis and cannabis derivatives with very low concentrations (no more than 0.3% on a dry weight basis) of THC — from the definition of marijuana in the Controlled Substances Act, CBD products are still subject to the same laws and requirements as FDA-regulated products that contain any other substance.

The FDA is concerned that people may mistakenly believe that using CBD “can’t hurt.” The agency wants to be clear that we have seen only limited data about CBD’s safety and these data point to real risks that need to be considered. As part of the drug review and approval process for the prescription drug containing CBD, it was determined that the risks are outweighed by the benefits of the approved drug for the particular population for which it was intended. Consumer use of any CBD products should always be discussed with a healthcare provider. Consumers should be aware of the potential risks associated with using CBD products. Some of these can occur without your awareness, such as:

  • Liver Injury: During its review of the marketing application for Epidiolex — a purified form of CBD that the FDA approved in 2018 for use in the treatment of two rare and severe seizure disorders — the FDA identified certain safety risks, including the potential for liver injury. This serious risk can be managed when an FDA-approved CBD drug product is taken under medical supervision, but it is less clear how it might be managed when CBD is used far more widely, without medical supervision, and not in accordance with FDA-approved labeling. Although this risk was increased when taken with other drugs that impact the liver, signs of liver injury were seen also in patients not on those drugs. The occurrence of this liver injury was identified through blood tests, as is often the case with early problems with the liver. Liver injury was also seen in other studies of CBD in published literature. We are concerned about potential liver injury associated with CBD use that could go undetected if not monitored by a healthcare provider.
  • Drug Interactions: Information from studies of the FDA-approved CBD drug Epidiolex show that there is a risk of CBD impacting other medicines you take – or that other medicines you take could impact the dose of CBD that can safely be used. Taking CBD with other medications may increase or decrease the effects of the other medications. This may lead to an increased chance of adverse effects from, or decreased effectiveness of, the other medications. Drug interactions were also seen in other studies of CBD in published literature. We are concerned about the potential safety of taking other medicines with CBD when not being monitored by a healthcare provider. In addition, there is limited research on the interactions between CBD products and herbs or other plant-based products in dietary supplements. Consumers should use caution when combining CBD products with herbs or dietary supplements.
  • Male Reproductive Toxicity: Studies in laboratory animals showed male reproductive toxicity, including in the male offspring of CBD-treated pregnant females. The changes seen include decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone, among others. Because these findings were only seen in animals, it is not yet clear what these findings mean for human patients and the impact it could have on men (or the male children of pregnant women) who take CBD. For instance, these findings raise the concern that CBD could negatively affect a man’s fertility. Further testing and evaluation are needed to better understand this potential risk.

In addition, CBD can be the cause of side effects that you might notice. These side effects should improve when CBD is stopped or when the amount used is reduced. This could include changes in alertness, most commonly experienced as somnolence (sleepiness), but this could also include insomnia; gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite but could also include abdominal pain or upset stomach; and changes in mood, most commonly experienced as irritability and agitation.

The FDA is actively working to learn more about the safety of CBD and CBD products, including the risks identified above and other topics, such as:

  • Cumulative Exposure: The cumulative exposure to CBD if people access it across a broad range of consumer products. For example, what happens if you eat food with CBD in it, use CBD-infused skin cream and take other CBD-based products on the same day? How much CBD is absorbed from your skin cream? What if you use these products daily for a week or a month?
  • Special Populations: The effects of CBD on other special populations (e.g., the elderly, children, adolescents, pregnant and lactating women).
  • CBD and Animals: The safety of CBD use in pets and other animals, including considerations of species, breed, or class and the safety of the resulting human food products (e.g., meat milk, or eggs) from food-producing species.

Unproven medical claims, unsafe manufacturing practices

Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices

Unlike the FDA-approved CBD drug product, unapproved CBD products, which could include cosmetics, foods, products marketed as dietary supplements, and any other product (other than Epidiolex) making therapeutic claims, have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns.

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.

In addition to safety risks and unproven claims, the quality of many CBD products may also be in question. The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed. We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC).

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.

The FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. For example, the agency has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes. While we have focused on these types of products, we will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.

Evaluation of the regulatory frameworks

The FDA is Continuing to Evaluate the Regulatory Frameworks for Products Containing Cannabis and Cannabis-Derived Compounds

The FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy. The agency is committed to supporting the development of new drugs, including cannabis and cannabis-derived drugs, through the investigational new drug and drug approval process.

We are aware that there may be some products on the market that add CBD to a food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way.

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.

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.

Our Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make informed choices about CBD products. Also, as the regulatory pathways are clarified we will take care to inform all stakeholders as quickly as possible.

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