Wellness Unmasked: New Melatonin Study Raises Red Flags

Summary

The Clay Travis and Buck Sexton Show – "Wellness Unmasked: New Melatonin Study Raises Red Flags"

Date: November 18, 2025
Guest Host/Speaker: Dr. Nicole Saphier

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Main Theme and Purpose

This episode of "The Clay Travis and Buck Sexton Show" (Wellness Unmasked segment) features Dr. Nicole Saphier diving into a newly released study that suggests a strong link between extended melatonin use and significantly increased risks of heart failure and all-cause mortality. Dr. Saphier unpacks the findings, questions some of the study's methodology, and provides evidence-based context to help listeners understand both the risks and the nuances. The episode shifts into a broader exploration of sleep health, highlighting both the dangers of poor sleep and practical strategies for better rest, especially during the holiday season.

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Key Discussion Points and Insights

1. Introduction to the Melatonin Study (03:06–05:15)

• Dr. Saphier shares how she came across the new melatonin study due to messages from friends and her own scientific curiosity.
• The study in question is a large-scale review of medical records from over 130,000 adults in the US and UK, focusing on those diagnosed with insomnia.
• The central finding: "Adults with insomnia who took melatonin for at least 12 months had a 90% higher chance of developing heart failure compared to the control group."
  – Dr. Nicole Saphier [04:00]

2. Key Findings of the Study (05:15–06:50)

• The melatonin group was nearly 3.5 times more likely to be hospitalized for heart failure and had almost double the risk of death from any cause over the study period.
• Dr. Saphier is upfront about the study’s impact:

  “They're not mincing words here. They're not saying, oh, it’s like a 2% increase, a 5% increase. They're like, nope, nearly 100% increased risk of death from any cause in the people who were taking melatonin. I mean, this is mind blowing..."
  — Dr. Nicole Saphier [05:45]

3. Critical Examination of the Study’s Methodology (06:50–11:03)

• Prescription vs. Over-the-Counter Melatonin: The study only considered those with a prescription for melatonin as "users," which is crucial because in the US, melatonin is mostly obtained over the counter, whereas it's prescription-based in the UK.
  • This introduces major confounding and possible misclassification.
  • Many "non-users" in the US arm may have actually taken OTC melatonin without a prescription, blurring distinctions between groups.
• Difference in Formulation:
  • Prescription melatonin (especially in the UK) is often extended-release, while US over-the-counter versions are mostly immediate-release.
  • Dr. Saphier asks, “Is it this extended release version that’s causing some sort of alteration in not only our brain chemistry, but is that actually having a role in our cardiovascular health? …That’s one question I had.” [09:20]
• Dosage Uncertainties: No mention of exact doses taken, which could dramatically change risk profiles.
  • “Are they taking 1 milligram for one year or are they taking 20 milligrams for one year? I mean, that kind of makes a difference, doesn’t it?” — Dr. Nicole Saphier [10:05]
• Underlying Severity and Lifestyle Confounders:
  • All participants were diagnosed with insomnia, but those who sought prescriptions might have had much more severe sleep issues, which in and of themselves increase cardiovascular risk.
  • The study didn't control for lifestyle factors like smoking, obesity, or preexisting heart disease.

4. Cautious Interpretation and Media Hype (11:03–12:25)

• Despite dramatic headlines, Dr. Saphier warns against alarmism:

  “I’m not really sure that’s the message here. In fact, I think we need to peel back those layers a little bit.”
  — Dr. Nicole Saphier [12:20]

• Suggests that what the data most likely exposes is risk associated with specific prescribed formulations, not necessarily all types or dosages of melatonin taken by the public.

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5. The Biology of Sleep and Its Health Impacts (16:24–22:50)

• Dr. Saphier transitions to emphasize why sleep itself is so vital:
  • Poor sleep is linked to elevated risks for cardiovascular disease, high blood pressure, dementia, depression, anxiety, and even cancer.
  • The neurohormonal axis is disrupted with sleep deficits, elevating stress hormones (cortisol, norepinephrine) and lowering serotonin.
  • Chronic sleep deprivation can shrink the hippocampus (memory formation) and prefrontal cortex (personality, self-control), potentially altering behavior or increasing the risk of dementia.
  • Memorable analogy: "It’s kind of like if you’ve had too much alcohol...well, that part of your brain that tells you...‘that’s not a good idea’—that’s your prefrontal cortex. When you lose volume in there, you lose the ability for your body to say...what’s right, what’s not right.” — [19:25]

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6. Prioritizing Sleep Without Relying Solely on Melatonin (22:50–25:35)

• Emphasizes that consistency in sleep routine trumps sheer total hours—“Your body wants to follow the same rhythm. You want to try really hard to go to bed at a similar time every single night.” [23:00]
• Advises limiting screen time at least 90–120 minutes before bed to reduce blue-light interference with natural melatonin production.
• Advocates for regular physical activity, relaxation techniques (like evening showers or hot tea), and not overextending oneself during the holiday season.
• Encourages self-forgiveness around not making every social event, and pacing oneself to protect mental and physical health.
  • “Don’t power through anything...Pace yourself. It’s a marathon, not a sprint. You have to be enjoying every moment of your life because every day is a blessing and nothing is guaranteed.” — [25:00]

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7. Her Take on Melatonin Supplementation Going Forward (25:35–26:40)

• Dr. Saphier is not wholly anti-melatonin but recommends caution, especially with prescription forms.
  • She uses (and includes in her own sleep aid) a very small, occasional (“microdose”) amount of melatonin (2 mg), alongside calming herbs such as lavender and chamomile.
  • Key advice: “…If you find yourself really not able to sleep without melatonin, take a look at the lifestyle and your bedtime routine, because maybe making some changes there are really what your body needs.” — [26:20]
• Invites listeners to share tips and reinforces that sleep is one of the single most important health choices we make.

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Notable Quotes & Moments

• On the confounding in the study:

  "That's a huge confounding factor. So that's a really big deal for me. It's just a misclassification of non users."
  — Dr. Nicole Saphier [08:20]

• On media coverage:

  "The way that this study has been picked up by the media and just broadly blasted everywhere of 'oh my gosh, melatonin, you have almost 100% risk of all cause mortality and death if you take melatonin.' I'm not really sure that that's ... the message here."
  — Dr. Nicole Saphier [12:05]

• On sleep routine:

  "Me, my goal, I love being in bed by 9:30pm every night. Does that mean that I'm usually the first to leave a party? Yep. And you know what? I'm okay because I love my sleep and I prioritize it. I really do."
  — Dr. Nicole Saphier [23:24]

• On sleep, holidays, and health:

  “While we tell ourselves, ‘all right, we just need to power through these next two months and then we're going to recover in January,’ the reality is we don't recover in January…So please don't power through anything. Prioritize yourself.”
  — Dr. Nicole Saphier [24:55]

• On melatonin going forward:

  “I'm certainly going to avoid those prescription melatonins, I'll tell you that much. [But am I] opposed to microdosing of melatonin and taking it occasionally? No, I'm not…If you find yourself really not able to sleep without melatonin, take a look at the lifestyle and your bedtime routine.”
  — Dr. Nicole Saphier [26:37]

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Key Timestamps

• 03:06 – Dr. Saphier introduces the melatonin study and its context.
• 04:00–05:45 – Alarming statistics from the study, initial reaction.
• 06:50–11:03 – Breakdown of study limitations and confounders.
• 12:05–12:25 – Media hype addressed.
• 16:24–20:45 – Dangers of chronic sleep deprivation.
• 22:50–25:35 – Holistic sleep improvement advice.
• 25:35–26:40 – Dr. Saphier’s melatonin takeaway and call for listener feedback.

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Summary Takeaways for Listeners

• Don’t panic about the dramatic headlines: The alarming statistics around melatonin and heart health may not apply to over-the-counter forms most Americans use due to differences in formulation and methodology confounding.
• Prioritize sleep health above all—regular routine, reduced blue-light exposure before bed, daily physical activity, and mindful boundaries during stressful seasons.
• Use melatonin, if at all, in moderation and consider focusing on foundational lifestyle changes first.
• Consult your doctor if struggling with sleep consistently, and be wary of prescription options unless clearly indicated.
• Above all, protect your sleep—not just as an “extra,” but as a cornerstone of mental and physical wellness.

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Dr. Nicole Saphier closes the episode with encouragement for listeners to share their own sleep tips and reiterates the importance of sleep for wellbeing, especially through life’s busiest and most stressful seasons.

Transcript

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[Dr. Nicole Safire]

A journey into How My Mind Works I found myself researching a certain study, a scientific study that came out in the last couple of weeks because a lot of friends were starting to text me about it. And of course me being me, I like to read about something. While I do occasionally speak off the cuff, I am, I am very data oriented. I'm like, let me just dive into the study. And then from there I went from that study to more studies to more studies to, I mean it kind of like ended up with me looking for aliens in like North Dakota or something. I mean that's just kind of how crazy my mind goes sometimes. But have you heard of the new study about linking melatonin to cardiovascular disease, heart attacks and just like all cause mortality? Well, if you haven't, it's probably the because of the whole Internet's being crashed the last day or so because it's a hot topic and people are freaking out because apparently a lot of people take melatonin. Who knew? So what is this study? Well, it's actually a really big study. It's not some random thing on the Internet that one person took melatonin and then had a heart attack. It's actually a big study done in the United states and the UK, kind of a collaboration study. They looked at over 130,000 adults, their medical charts. So it's pretty, pretty well powered study. A lot of people in it. And what they looked at was adults who were diagnosed with insomnia and so about 130,000 adults who had been diagnosed with insomnia. And what they looked at was how did the people do who were taking melatonin versus people who are not taking melatonin. And I mean, to be honest, there were some pretty startling science statistics that came out of the study. And if you look at what's being quoted, they Said over a five year period, adults who took with insomnia, who took melatonin for at least 12 months had a 90% higher chance of developing heart failure compared to the control group. I mean, that's, that's pretty significant. 90% higher chance. Yeah, I, I think if you were told there's a 90% chance you're going to get heart failure for something, you probably wouldn't take it. They went on from there. The melatonin group was nearly 3.5 times more likely to be hospitalized for heart failure and also had a nearly 100% increased risk of death from any cause during the study period. I was like, whoa, like, they're not mincing words here. They're not saying, oh, it's like a 2% increase, a 5% increase. They're like, nope, nearly 100% increased risk of death from any cause in the people who were taking melatonin. I mean, this is mind blowing because the reality is, yeah, I've taken melatonin. I think every person in my life has taken melatonin, including my children. So obviously I decided to dig a little bit deeper into this study because it's pretty startling. It really is. I mean, if you go to any cvs, Walgreens nutrition store, melatonin's everywhere. So let's break down this study. Like I said, it's well powered. Over 130,000 medical charts were reviewed. That's a, that's a good number. Big issue that I had in it was the fact that when they, the people who said they took melatonin, so that group, the melatonin takers, they were only people who had prescription melatonin. Now you're like, wait, what? A prescription? Why, why would anybody take a prescription melatonin? You just go to CVS and grab it. Yes, in the United States, that's true. If you go to the uk, where a lot of this patient population were, it's not over the counter and you do actually need a prescription. So here's the question I have in the people who were considered non melatonin users because they didn't get a prescription, did any of them actually take melatonin? Because some of these patients are from the United States. And by the way, melatonin's over the counter. It's not like they asked the patients, all they did was look at prescription history. So any of the patients that were from the United States who had traveled to the United States or maybe buy medication from the United States, they may not actually have been included in that control group and they may have been falsely included in the non melatonin user group. That's a huge confounding factor. So that's a really big deal for me. It's just a misclassification of non users. And so this could underestimate the, the number of people who actually took melatonin. And again, if people in the quote unquote non melatonin user group were taking over the counter melatonin, is that something to be said for the prescription melatonin that you get in the uk? Maybe it's formulated differently than the over the counter one you get here in the United States. So of course I looked into that. Now we start seeing this rabbit hole that I decide to go down because that's what I do. If you actually look at the melatonin that is prescribed in, say, the uk, there's one in particular that kind of piqued my interest. It's an extended release formulation. Now in the United States, the common complaint that people get when they take melatonin is, yeah, it helps me fall asleep, but I don't stay asleep. And that's because they're usually pretty short acting and so forth. For people who don't see a benefit with melatonin, it's usually because it doesn't last throughout the entire night, which is probably why the prescription form is extended release. So it continues to be released throughout the night. So my question is, is it this extended release version that's causing some sort of alteration in not only our brain chemistry? Obviously that's what it's designed to do, but is that actually having a role in our cardiovascular health? So I don't really know. So that's one question I had. Another thing that I was looking at was what about the dosages and the bioavailability? You know, when you go and you take these little melatonin gummies, you're probably getting a much lower dose because the bioavailability and after metabolism is likely to be much lower than if you're actually having a pharmaceutically formulated capsule that bypasses a lot of the digestive enzymes. Um, and it probably has a more efficient metabolism when it goes through the liver. So my guess is again, I'm not a chemist or biopharmaceutical whiz, but my guess is you're probably getting higher dose of the melatonin from these pharmaceutical formulations. On top of that, in the study there was no mention of dosages. It just is the, the study defines, quote, unquote, use of melatonin. As at least just for one year. So, okay, well are they taking 1 milligram for one year or are they taking 20 milligrams for one year? I mean, that kind of makes a difference, doesn't it? And then lastly, when it comes to this study, the big thing was everyone, those who were quote unquote, the users of melatonin and those who are, quote, unquote, the non users of melatonin, they all had to be diagnosed with some form of underlying insomnia severity or a sleep disorder. So my question is, for the people who are considered the users of melatonin, was their insomnia more severe, more profound than the non users? It was so profound that they actually went to their doctor seeking medical attention and then therefore got a prescription. Because we also know that by the way, lack of sleep or poor sleep is detrimental to our health. And so that didn't, they don't really talk about severity of the sleep deprivation. And I'm gonna go into another rabbit hole I went into when it comes to sleep deprivation. But so I think when it comes to this whole study, you know, they obviously, they also didn't account for like unmeasured lifestyle variables, who were smokers, who were obese, who, you know, any of these things, who had pre existing heart disease, any of these things they didn't really mention in the study. So while I think it's a very interesting study, obviously very concerning the stark differences that came from the users of melatonin versus the non users, I'm not quite sure we're there yet. And in fact, I personally would want to look at the prescription formulations of melatonin to see if that itself is the reason that there is an increased risk. In fact, the, that extended release, one that I mentioned earlier, it was not approved here in the United States. It actually got through phase three trials and failed, not approved here in the United States. So I think this is my thought process is that there, it has something to do with the formulations that are being prescribed of melatonin. And maybe looking at that extended release specifically would be of interest. But the way that this study has been picked up by the media and just broadly blasted everywhere of oh my gosh, melatonin, you have almost 100% risk of all cause, mortality and death if you take melatonin. I'm not really sure that that's, I'm not really sure that that's the message here. In fact, I think we need to peel back those layers a little bit. You're listening to Wellness en masse. We'll be right back with more.

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You know what?

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You got a little Colin Firth.

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[Dr. Nicole Safire]

What I want to now go into because while my little research started off with that started off with let's talk about melatonin, I actually want to focus a little bit more on what happens specifically to your brain when you don't sleep well. And you know, it's, it's a really important thing because before people start throwing all the melatonin away and saying forget it, I'm not doing this, melatonin's bad, blah blah blah, let's talk about sleep for a second. So we know that sleep is crucial. It's crucial for our mental health and it's crucial for our physical health. Poor sleep is associated with all cause mortality. Just like that study said melatonin was shocking. Poor sleep increases our risk of cardiovascular disease, high blood pressure, dementia. Let me think, what else? Depression, anxiety. I mean if you list, and actually cancer too, if you list any disease, I can guarantee I can find you a study linking poor sleep to that. So why is that? Why is poor sleep so detrimental to our health? Well, when you're not sleeping very well, your entire neuro access of all of the hormones and biochemicals that are going on in your body is completely off your body. God made your body very precisely. It is follows a very natural and precise circadian rhythm and flow and hormones are released at very specific times that are supposed to be beneficial to our body. When you disrupt that with poor sleep, it throws everything out of whack. You have a disruption of your normal circadian rhythms. Your serotonin, which is that happy hormone production gets disrupted. We know that when we see people with depression and anxiety, sometimes they have low serotonin. We also see that with poor sleep you have a rise in cortisol. Cortisol is that stress hormone and another one that you see is norepinephrine. These are your fight or flight response. You know, if you in a back alley and someone jumps at you and then all of a sudden you get super scared and your heart goes fast and you start sweating and you have superhuman strength, that's that fight or flight. Those are your stress hormones. Now those are great in short bursts, they are designed to protect us. In short bursts they will actually do the opposite effect to us if they remain chronically elevated. They work against our body, create a state of inflammation and can have consequences such as autoimmune disease, cancer and other illness. If you actually look at the brain in people who have sleep deprivation, if it happens in the short term, like you're cramming for a test or you are, you know, anything that you have a short term sleep deprivation, it's just happening for a few days. You already can see if you measure brain activity using functional mri, you see an alteration in the brain activity. We also know by doing blood tests that you see an alteration in the, the hormonal chemicals in the body. But if you actually now look at the brain over time with chronic sleep deprivation, and there have been studies looking at prisoners of war prisoners in general and just other people with chronic sleep deprivation, not only do you see an alteration in the brain chemical structure, you see an alteration in the brain itself. There's volume loss. You lose volume in very key parts of the brain. One being the hippocampus, which is responsible for form memory, another being the frontal lobe cortex, which is responsible for your ability to your personality for one, but also your ability to control oneself. So when you lose that prefrontal cortex, your entire personality can change. And you also may actually the way that you can liken this to, if you've had too much alcohol, you're kind of disinhibited. You know, maybe you wouldn't have gone streaking down the quad if you hadn't been drinking alcohol. Well, that part of your brain that tells you, you know what, streaking down the quad, that's not a good idea. That's your prefrontal cortex. So when you lose volume in there, you lose the ability for your body to say, well, this is what's right, this is what's not right. And actually a lot of our dementias affect that prefrontal cortex, which is why people with dementia, you see them act differently and maybe they're doing things that socially inappropriate or something that they would have just never done before because the behavior is just Totally out of whack for them. So chronic sleep deprivation can lead to that. So on Fox and Friends this weekend, I talked all about, you know, everyone going into the holiday season. They're like, all right, let me get on my GLP1. Let me try and lose £10. What's the latest hairstyle or makeup trend on social media? Like, everyone's just concerned a little bit about crap. And heading into the holiday season, we know that people have an increased feeling of isolation, depression, anxiety, and that negative mental health directly impacts our sleep. And so I am imploring everyone to let's focus a little bit more on our sleep health and our brain health heading into the holiday season. So the biggest thing you can do instead of just grabbing for melatonin. Hold on. Melatonin may be on my list for helping, but let's talk talk about some things we can do to prioritize sleep without the melatonin. First and foremost, you have to try and get seven to nine hours of sleep every night. But. And there's a big but to this. It can't be. I go to sleep at 9pm one night and then I get nine hours and then the next night I go to sleep at midnight and I get nine hours. That's not it. Remember I told you about that rhythm? Your body wants to follow the same rhythm. You want to try really hard to go to bed at a similar time every single night. So whether you get seven hours or nine hours is less consequential than going to bed around the same time each night. Me, my goal, I love being in bed by 9:30pm every night. Does that mean that I'm usually the first to leave a party? Yep. And you know what? I'm okay because I love my sleep and I prioritize it. I really do. On top of that, you really have to power down electronics and screens. I mean, they say 90 to 120 minutes before bed. I know that's hard. In my house, we do watch TV before bed. It is something we do, but it's not ideal. And so the best thing to do is to power down those devices. Because that blue light that's coming at you from those devices, they're also disrupting your body's ability to naturally make its melatonin. And naturally, your body is saying, oh, there's a light. It's daytime. It is not time for bed. You power down those screens so your body can be like, okay, now it is time. Let's convert some of this serotonin into melatonin. And that melatonin is going to tell my brain it's time for bed. By keeping those screens on, you're disrupting that circadian rhythm. You're working against your body to get to sleep. It is what it is. What else can we do? We also, you know, exercising every single day. And that doesn't mean going to the gym and being a weightlifter and blah, blah, blah, all that stuff. It means just move your body a little bit. You know, I was working in the hospital yesterday. I did not get to the gym before or after, but I did use the stairs. I didn't use the elevator and I kind of did two steps at a time, went as fast as I could, just trying to move my body a little bit. Because if you move your body during the day, you get your, you know, reach that goal heart rate, get your heart and your blood flowing. That does help you sleep at night. Some people like to shower or sauna at night and that can help you relax and kind of set the mood for the day. And another thing that is actually really good as we head into the holiday season is to forgive yourself and say, it's okay not to say yes to every single party. I promise you, they'll still be your friends even if you say no to their holiday party this year. We tend to overdo it during the holidays. And while we tell ourselves, all right, we just need to power through these next two months and then we're going to recover in January, the reality is we don't recover in January. We power through it and then we power through something else that happens in January, February and March. So that mentality is terrible. Like I said, on the short term, you are affecting your body, your brain. So don't power through anything. You know, pace yourself. You know, it's a marathon, not a sprint. And you have to be enjoying every moment of your life because every day is a blessing and nothing is guaranteed. So. So please don't power through anything. Prioritize yourself. Prioritize your family and your friends and focus on your sleep. If you really are struggling to get some sleep, you can go talk to your doctor. They may have some advice, but you may still consider low dose melatonin. You know, I'm not opposed to it. Even after this scary study came out. You know, I put together, we all know that I love liquid herbs. My sleep formulation does have a microdose of melatonin in it. It's 2 milligrams. But it also has a whole bunch of other natural herbs that are meant for calming, you know, we have lavender, chamomile. I love hot tea before bed. Those natural herbs can also help calm you. I don't want anybody to be super freaked out about this melatonin study. I take it with, you know, take it with caution. I'm certainly going to avoid those prescription melatonins, I'll tell you that much. I oppose to microdosing of melatonin and taking it occasionally. No, I'm not. If you find yourself really not able to sleep without melatonin, take a look at the lifestyle and your bedtime routine, because maybe making some changes there are really what your body needs. Not so much the melatonin, but. So that's my. That's my little saga when it comes to melatonin. That study, sleep, getting through the holidays, and we're all in this together, everyone. Okay? If you have any tips on what helps you sleep, please reach out to me on social media, Instagram, whatever it is, send me a message. I love hearing other people's tips and tricks because sleep is crucial. And if there's one thing that you want to prioritize in your life, it is your sleep. So I'm open to hearing from all of you. Thank you so much for listening to Wellness on Mass. I'm Dr. Nicole Safire. Make sure you listen to Wellness on Mass on iheartradio wherever you get your podcast and we will see you next time.

[Kal Penn]

Hey, audiobook lovers. I'm Cal Penn.

[Ed Helms]

I'm Ed Helms.

[Kal Penn]

Ed and I are inviting you to join the best sounding book club you've ever heard with our new podcast, Irsay, the Audible and iHeart Audiobook Club.

[Ed Helms]

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[Kal Penn]

Greatest audiobooks from audible, listen to Earsay on America's number one podcast network, iHeart. Follow Earsay and start listening on the free iHeartradio app today.

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