STAT+: Closely watched experimental Parkinson’s drug fails key clinical trial

Biogen and Denali Therapeutics said Thursday that their experimental therapy for Parkinson’s disease failed to slow the degenerative brain disorder in a randomized trial, dealing a substantial blow to a scientific approach that stoked excitement among advocates and academics. 

In the study, 648 adults with Parkinson’s were randomized to receive either a placebo or a pill targeting a protein called LRRK2. In 2004, researchers discovered that mutations in the LRRK2 gene can cause a rare, inherited form of Parkinson’s. And in 2018, another group of scientists showed that blocking the protein might actually benefit all patients with the disease. 

Thursday’s results are a significant setback to the latter idea. 

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STAT+: 3 burning questions senators had for the NIH director

Thursday’s Senate Appropriations Committee hearing was intended to focus on President Trump’s proposed budget for the National Institutes of Health’s fiscal year 2027 budget. 

Instead, many of the senator’s questions for NIH Director Jay Bhattacharya and the five institute directors who joined him focused on more immediate concerns: a leadership vacuum at the agency’s sprawling infectious disease institute amid two outbreaks, the slow pace of funding over the course of the current fiscal year, and the impact of various Trump administration policies on the research community. 

Here are three questions that were raised during the hearing: 

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STAT+: Merck-Kelun lung cancer drug cut risk of tumor progression by 65%, ASCO abstract shows

A type of targeted chemotherapy developed by China-based Kelun-Biotech and licensed to Merck cut the risk of tumor progression by 65% in patients with lung cancer, according to Phase 3 study results reported Thursday. 

A preliminary survival benefit favoring the Kelun-Merck drug, called sacituzumab tirumotecan, or sac-TMT, was also seen in the study, but will require longer follow-up to confirm.

The study, conducted in China, is the first successful combination of an antibody-drug conjugate with a PD-1-targeted immunotherapy in patients with advanced but previously untreated non-small cell lung cancer. 

Continue to STAT+ to read the full story…

Conceptualizing Acceptance and Knowledge as Process Variables in Internet-Delivered and Therapist-Supported Cognitive Behavioral Therapy and Acceptance and Commitment Therapy in Primary Care for Insomnia: Pilot Feasibility and Process-Oriented Randomized Controlled Trial

Background: Internet-based interventions for insomnia show promise, but understanding the process variables, such as knowledge acquisition and psychological acceptance, is crucial for enhancing digital adherence and clinical effectiveness. Objective: This study aimed to evaluate the feasibility, adherence, and preliminary clinical signals of 2 therapist-assisted interventions—internet-delivered cognitive behavioral therapy (iCBT) and internet-delivered acceptance and commitment therapy (iACT)—for insomnia in a primary care setting. Methods: This was a pilot randomized controlled trial. Adults seeking help for insomnia (n=18) were recruited via primary care and randomized to either a 5-module iCBT or iACT program delivered via a secure digital platform with weekly therapist feedback. Blinding of participants and therapists was not possible due to the nature of the interventions. Primary outcomes included the Insomnia Severity Index; secondary outcomes included the 9-item Patient Health Questionnaire, 7-item Generalized Anxiety Disorder, and WHO Disability Assessment Schedule. A novel sleep knowledge test was used as a process variable. The data were analyzed using split-plot analyses of variance (intention-to-treat or last observation carried forward and complete case analysis) and nonparametric Friedman and Kruskal-Wallis tests. Results: A total of 18 participants were randomized (iCBT: n=9; iACT: n=9). High attrition was observed, with only 33.3% (n=3) of iCBT and 55.6% (n=5) of iACT participants completing all modules. The iACT group demonstrated a significant within-group reduction in insomnia severity (=.01, Friedman test), whereas iCBT results were nonsignificant (=.10, Friedman test). No significant between-group differences were found for any clinical or process variables. Participants rated both treatments as credible (Credibility/Expectancy Questionnaire scores remained stable), though qualitative feedback indicated a need for more flexible, less burdensome content. Conclusions: This pilot study demonstrates that while internet-delivered insomnia treatments are feasible and credible in primary care, high attrition remains a significant barrier. Preliminary signals suggest that iACT may be a viable alternative to iCBT, potentially offering better adherence. Larger, fully powered pilot randomized controlled trials (estimated N=404) with refined recruitment and automated retention strategies are required to determine definitive comparative efficacy and the mediating role of sleep knowledge and acceptance. Trial Registration: Research and Development in the Västra Götaland Region (FoU i VGR) 272866;
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/afbaf4554a19449ff56c7c7894d41783" />

Roundtables: Can AI Learn to Understand the World?

Listen to the session or watch below

AI companies want to build systems that understand the external world and overcome the limitations of LLMs. Recent developments have brought world models to the forefront of the AI discussion.

Watch a conversation with editor in chief Mat Honan, senior AI editor Will Douglas Heaven, and AI reporter Grace Huckins exploring how AI might enter the physical world.

Speakers: Mat Honan, Editor in Chief, Will Douglas Heaven, AI Senior Editor, and Grace Huckins, AI Reporter

Recorded on May 21, 2026

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<![CDATA[Explore how integrated psychotherapy—CBTp, family support, and humane alliance—reduces relapse and restores meaning beyond medication in schizophrenia.]]>

Melatonin for Kids: Is It Safe?

If you’ve spent any time talking to other parents about sleep, you’ve probably heard about melatonin. One person swears by it. Someone else warns against it. And if your child is struggling to fall asleep, it can be hard to know what to believe.

Melatonin is widely available, often marketed as a “natural” sleep aid, and increasingly used to help kids of all ages. But it may not be the right solution. The key is knowing when it makes sense, when it doesn’t, and how to make it work best as part of a bigger sleep plan.

What is melatonin?

Melatonin is a hormone the body produces naturally to regulate sleep. As it gets dark, the brain releases melatonin to signal that it’s time to wind down. Light exposure at night — especially blue light from screens — can disrupt the body’s natural rhythm so you don’t feel sleepy even when it’s bedtime.

“Melatonin supplements can help facilitate that circadian rhythm, that 24-hour sleep cycle,” says Rohn Nahmias, DO, a child and adolescent psychiatrist at the Child Mind Institute. Because it’s sold over the counter, melatonin seems to be harmless. In practice, clinicians are much more cautious. While they tend to consider it relatively low risk, with few side effects, they still don’t view it as something to take casually or indefinitely.

That’s because there are real gaps in what we know about melatonin — especially when kids take it regularly over long periods. “The longest study was about four years, and they did not find any issues,” says Judith Owens, MD, MPH, a pediatric sleep expert and professor of neurology at Harvard Medical School. “But the data are very limited in subject numbers and long-term follow-up.”

So, the question parents often ask — is melatonin safe for kids? — doesn’t have a simple yes or no answer. The more useful question may be whether melatonin is right for your kid and what guidelines should you follow if you’re going to give it to them.  

That’s why it’s especially important to consult your child’s pediatrician or tell them if you’ve already started your child on melatonin. “Because melatonin is over the counter, families often forget to mention it,” says Dr. Nahmias. But doctors need to know about supplements, especially if a child is on other medications or has additional health concerns.

Melatonin can be helpful in the right situations, but using it without looking deeper can be “kind of slapping a Band-Aid onto a problem,” Dr. Nahmias says. In his practice, he always wants to rule out anxiety, mood concerns, or a medical issue that may be impacting sleep (such as snoring, breathing problems, or pain) before introducing something new like melatonin.

When melatonin can help

Melatonin is most useful when the issue is falling asleep, not staying asleep. For example, if your child has persistent trouble falling asleep — not just occasional bedtime resistance — and you have already tried using behavioral strategies.

The immediate-release melatonin sold in the United States is primarily helpful for sleep onset. (A prolonged-release form approved in the UK and EU may help with staying asleep, but it’s not available here.) Melatonin can also help with circadian rhythm issues like delayed sleep-wake phase disorder, when a child or teen’s natural sleep and wake times are much later than their schedule allows. “That is the other real indication for melatonin,” Dr. Owens says.

How to use melatonin thoughtfully

If melatonin does make sense for your child, experts agree: Start low and go slow. Dr. Nahmias recommends beginning with 1 to 2 milligrams for kids four and up and increasing the dose only if needed — up to 3 milligrams for kids ages 6–10. Many children respond well to low amounts. More than 5 milligrams, he says, isn’t much more effective and is more likely to cause side effects like grogginess or irritability. Dr. Owens emphasizes a similarly cautious approach: Use the lowest effective dose, monitor whether it’s actually helping, and reassess regularly rather than letting it quietly become an open-ended routine.

Dr. Nahmias recommends using melatonin in “clusters” — short, purposeful stretches of nightly use to help realign the circadian rhythm — and then pulling back to use as needed. A cluster might make sense for a few weeks after travel, during a tough transition, or while the family works on behavioral changes.

If a child needs melatonin every night for months, that’s a signal to dig deeper. “That tells me that there’s something likely going on underneath that’s not being addressed,” Dr. Nahmias says.

Side effects and safety

Melatonin is generally well tolerated, but knowing the possible side effects can help you catch problems early. The most common is grogginess the next morning. Others include irritability, headaches, dizziness, stomach upset, and — in toddlers and younger children — increased bedwetting. Some children may also experience vivid dreams or nightmares, though these tend to be mild.

Check in with your child’s pediatrician if side effects appear, your child needs melatonin frequently or for more than a short period, the dose keeps creeping up, sleep problems get worse, or if you notice signs of anxiety, depression, or ADHD that might be driving their sleep struggles.

One important safety note: melatonin gummies look like candy, and Dr. Owens describes an “astronomical increase” in calls to poison control centers and emergency room visits related to melatonin in children, largely due to accidental ingestion. Store melatonin — especially gummies — like any other medication: out of reach, ideally in a locked cabinet. Never present them to children as a treat.

A bigger concern: what’s actually in the bottle

Melatonin isn’t tightly regulated in the United States, which means the dose on the label may not match what’s actually in the product. Studies have found that 22 out of 25 over-the-counter melatonin gummies were labeled inaccurately, with some containing far more melatonin than advertised.

Dr. Owens describes the variability as “huge” and says she was genuinely shocked by the findings. When shopping, look for products with a USP Verified mark. USP (United States Pharmacopeia) is an independent nonprofit that tests supplements to confirm the product contains what the label says, in the correct amount, and without harmful contaminants.

Melatonin for kids with ADHD or autism

There’s solid evidence that melatonin can benefit children with neurodevelopmental conditions, particularly autism and ADHD, who are more likely to have disrupted sleep-wake cycles. “There is a pretty robust literature supporting efficacy, without a lot of side effects,” Dr. Owens says about children on the autism spectrum.

But Dr. Nahmias encourages parents of kids with autism or ADHD to take a closer look at bedtime routines before turning to melatonin. “Both of those populations of kids do best when there is structure put into their day,” he says. He recommends having a posted list of the sleep routine that a child needs to accomplish as a helpful visual reminder that will start to become second nature as it is built into their evening.

If getting to sleep is still an issue, trying melatonin makes sense. But for kids with autism and ADHD, it may take more time to see an effect. “It can be helpful to give it a bit longer to re-right the sleep cycle,” Dr. Nahmias says. “Trying it for two to three months may be more beneficial than just a few weeks.”

 Many neurodivergent kids may also need to stay on melatonin longer than neurotypical children. “This makes it absolutely imperative that administration of melatonin for these children is under the supervision of a health professional who can monitor efficacy and side effects, and recommend periodic ‘off-drug holidays,’” Dr. Owens says. The goal is to get sleep back on track and consistent for some time. Once that goal is achieved, Dr. Nahmias adds, “it is important that there be attempts to take breaks from the medication or try lower doses.”

When melatonin is not likely to help

Melatonin is often used in situations where it’s unlikely to make much difference. That’s not a criticism of parents — sleep deprivation is exhausting, and it’s natural to reach for something that seems gentle and accessible. But if the real issue is an inconsistent routine, untreated anxiety, or an unidentified medical problem, melatonin may only be a temporary solution. The real problem will persist and need diagnosis and treatment.

For younger children — kids under five, especially — sleep problems are almost always better addressed with changes in habits and routines rather than supplements. For kids under two, “there’s no reason to use melatonin… and really, honestly, under five, for the most part,” Dr. Owens says. At those ages, behavioral approaches almost always work better.

What to try before using melatonin

Small, consistent changes in sleep habits can make a real difference — and unlike a supplement, these strategies can help children build skills that support sleep for years to come. Dr. Nahmias focuses on what’s often called sleep hygiene: a consistent bedtime and wake time, a predictable wind-down routine, and a sleep environment that actually supports rest, like keeping the bedroom dark, cool, and quiet. “The bed is meant for one thing and one thing only, and that is for sleep,” he says, emphasizing no TV or cellphones before bed. Even small amounts of light can interfere with the body’s natural melatonin production.

He also suggests addressing anxiety, rumination, or bedtime fears directly. “Behavioral interventions, time and time again, have really been shown to be very effective,” Dr. Owens says. For younger children, that might mean learning to fall asleep without a parent in the room. For older kids and teens, it often means setting limits around devices and making sure the schedule they’re keeping is actually realistic.

Making a melatonin plan

Melatonin is a tool that works best with a plan behind it. Before starting, write down what problem you’re actually trying to solve. Is your child unable to fall asleep before 11pm? Waking during the night? Scared to sleep alone? Anxious about school?

A simple sleep log can make your conversation with your child’s doctor much more useful. For a week or two, track bedtime, approximate time asleep, any night wakings, morning wake time, screen use, and whether melatonin was used and, if so, at what dose. Dr. Owens calls sleep diaries “invaluable” because they reveal patterns that are nearly impossible to see when everyone’s tired and running on memory. That information helps you and your child’s doctor decide whether melatonin is worth trying, whether it’s working, and when it might be time to stop — keeping the focus not just on getting through tonight, but on helping your child build the sleep habits they’ll carry with them for years.

Frequently Asked Questions

Is melatonin safe for kids?

Melatonin is generally considered low risk and can be helpful for some children who have trouble falling asleep, especially when used short term and under a doctor’s guidance. But experts caution that there are still gaps in research about long-term use in kids, so it shouldn’t be treated as harmless or used casually without looking at underlying issues.

Can you OD on melatonin?

Accidental overuse can happen, especially because melatonin gummies may look like candy to young children. In recent years, there has been a major increase in poison control and ER visits related to accidental ingestion, so melatonin should always be stored like any medication — out of reach and ideally locked away.

Is melatonin bad for kids?

Melatonin is not inherently “bad” for kids, but it’s not the right solution for every sleep problem. If poor sleep is caused by anxiety, inconsistent routines, or a medical issue, melatonin may only mask the problem.

How much melatonin is safe for kids?

Experts recommend starting with the lowest effective dose. Some clinicians suggest starting with 1–2 milligrams for children ages four and up, and generally not exceeding 3 milligrams for kids ages 6–10 unless advised by a doctor.

The post Melatonin for Kids: Is It Safe? appeared first on Child Mind Institute.