Aileen Maritato had a secret.
She would go to bed at night, fall asleep, then wake in the morning to find her kitchen scattered with leftover snacks – along with a very bemused husband.
He knew he wasn’t the culprit so he put his wife under surveillance.
He discovered that at around 3am each night, the 60-year-old mother-of-two had been creeping downstairs to devour everything she could get her hands on, from peanut butter sandwiches to Goldfish crackers and even blueberries.
But she had zero memory of doing it.
Maritato has not been formally diagnosed with any sleep disorder apart from insomnia but believes she has nocturnal sleep-related eating disorder (NSRED), a parasomnia (sleep associated with abnormal behaviors) that afflicts close to five percent of American adults.
She was prescribed the sleep medication Ambien, as well as an antidepressant, to improve her sleep and mood. But the damage was done.
Sick of the extra weight she’d gained on her 5’2” frame from her sleep binges – she was up to about 150 lbs – she took drastic action to shed it.
Aileen Maritato, 60, walked two miles every other day, ate well and injected semaglutide weekly, but she was struggling to lose weight
At 5’2” and about 145 lbs, Mrs Maritato’s BMI was 28, two points lower than the requisite level for insurance coverage for weight-loss injections. So she had to go private
She walked nearly two miles with her dogs every other day, incorporated more whole foods into her diet and, most importantly, injected herself every week with a compound formulation of semaglutide – which some have colloquially dubbed ‘Frankenzempic’.
This is the active ingredient in weight-loss drugs Ozempic and Wegovy, also known as GLP-1 drugs after the naturally occurring hormone which slows stomach emptying so people feel fuller for longer, stabilizes blood sugar levels and curbs appetite.
‘I stopped sleep eating about six months ago, but my weight wasn’t coming down. So, I thought, let me try one of these compounded things, because everyone else is so successful, everyone’s losing weight on GLP-1,’ she told the Daily Mail.
Yet her weight barely budged.
‘I maybe lost 2lbs in the first month and then my weight was just maintained,’ Maritato said.
This was far from the astounding results she had seen among celebrities, her own family members, and in clinical trials that boast an average loss of 20 percent of a person’s body weight.
The lackluster weight loss made the side effects – near-constant stomach upset, nausea, and diarrhea – even more unbearable.
Maritato now fears she may have been dosing herself with an ineffective drug that ‘some guy is making in his basement’.
She is one of the millions of Americans who take or have taken what are known as ‘compounded’ GLP-1s.
Compounded medications are custom-made drugs made at specialized pharmacies and marketed as containing the same active ingredients as FDA-approved drugs like Ozempic and Wegovy. However, their specific formulations are not reviewed by the agency first.
So-called ‘Frankenzempic’ comes in vials requiring a patient to draw up with a syringe themselves (the brand-name versions come in pre-filled injectable pens).
Compounding pharmacies will often add a dissolvent to dilute the active ingredient to a desired concentration – sterile water, for instance – while buffer solutions maintain the correct pH, and preservatives like benzyl alcohol prevent bacterial growth in multi-dose vials. (Stabilizers such as sugars or antioxidants protect the drug from degradation, and tonicity adjusters like sodium chloride ensure the solution is compatible with the body.)
The upside of these compound weight-loss formulations is that they are significantly cheaper than branded products like Ozempic, Wegovy and Mounjaro, etc that can cost around $1,000 a month.
However, because they are not regulated by the FDA in the same way as brand-name drugs, the compound meds can be at risk of tampering or unapproved changes. Nor does the FDA have oversight of where or how they are prepared.
Shockingly, there have been around 10 deaths and 100 hospitalizations in the US from 2018 to the fall of 2024 associated with the use of off-brand, compounded semaglutide, according to Novo Nordisk, the manufacturer of Ozempic and Wegovy.
Weight-loss injections are typically inserted into a person’s belly. A short needle is injected, and medicine is dispensed from a plunger
Maritato was prescribed a compounded combination version of semaglutide and tirzepatide (the active ingredient in Mounjaro) through an online platform popular for dispensing compounded versions of generic Viagra. It has not returned the Daily Mail’s request for comment.
The non-brand vials cost roughly $400 per month instead of $1,200 for a branded pre-filled pen version.
The medicine seemed to suppress Maritato’s appetite, but she believes she was eating so little it slowed down her metabolism.
‘I’m not a big eater,’ she said. ‘I probably eat about 800 to 1000 calories a day. If I became more active, I think I would have lost weight.’
But Maritato also wonders if she could have been given a placebo instead of the real thing.
‘I weighed myself weekly, and I didn’t see any significant loss or gain.’
Instead, her weight remained steady at around 145lbs.
At 5ft 2 with a BMI of 28, Maritato was considered overweight rather than obese. Her goal was a loss of around 15lbs.
She thinks that this could be a contributory factor. Many of the people she’s seen lose weight on GLP-1 injections were much heavier.
‘If someone wanted to lose 100 pounds, and they lost it in a year then they really succeeded. But for people trying to lose just 20 or 10 pounds, it just didn’t seem as effective. I think maybe the medication works better for people with a faster metabolism or more fat cells. But I’m not sure about the science behind it,’ she said.
‘It was almost as if I was getting a placebo, but I did have side effects, although that could have been psychological,’ she continued.
The exact number of Americans using compounded semaglutide (and other compounded weight loss medications) is unclear. However, estimates suggest that up to 20 percent of semaglutide prescriptions, particularly during shortages of branded jabs, may be compounded versions.
If up to 12 percent of American adults are taking one of these medicines, this could equate to more than six million people.
Mrs Maritato took the medicine from August 15 through November 15, but has since stopped. Her weight has not changed
Ozempic, the first of the new generation of GLP-1 drugs, was developed for people with Type 2 diabetes and/or suffering from obesity.
Its wider role as a ‘miracle’ weight-loss drug for the masses – and the development of similar drugs – is more recent and caused a sensation when the jabs hit the market.
The wealthy and famous were the first to realize the potential of the drugs as a painless, almost instant solution to unwanted pounds.
This caused protracted shortages that meant people who would medically benefit from the drugs could not always access them because supplies had been snapped up.
When compounding an off-brand, weight-loss formulation, the pharmacist considers the dosage and ingredients and ensures the final product is uniform in strength.
However, in July 2023, the FDA reported receiving multiple adverse event reports, some requiring hospitalization, linked to dosing errors with compounded semaglutide injectable products.
There have also been dosing errors resulting in negative reactions to the drugs requiring hospitalization.
The FDA has flagged concerns about some compounders using salt forms of semaglutide, such as semaglutide sodium or acetate, which differ from the active ingredient used in approved drugs and lack established safety and efficacy data.
It could just be that Maritato is one of the estimated 20 percent of patients who do not respond well to the medications.
But she believes that had she taken the branded version of the drug – Wegovy or Mounjaro for example – she would have seen better results.
‘I haven’t seen anyone be unsuccessful when they get the brand name from the pharmacy, so now I’m questioning whether or not the off-brand stuff is actually effective,’ she said.
‘I’ve been pretty consistent in doing what I do, but this didn’t have any effect on me at all.’
‘You don’t know who’s making it, you know? There aren’t [the same] quality controls [as] with the FDA, so it could be that some guy is making in his basement,’ she added.
She says she tried to get access to a brand-name version of semaglutide. She has co-morbidities that would benefit from treatment with the drugs, including underlying high blood pressure and kidney disease.
But her insurance provider, Blue Cross/Blue Shield, would not cover the cost because her BMI was two points lower than the requisite level for insurance coverage.
Facing ongoing pressure to lower the cost of the medications to widen access to those who would benefit from them, Eli Lilly reduced the price of its GLP-1 Zepbound by almost 50 percent in August 2024 to compete with off-brand versions.
It now sells for $399 to $549 monthly, down from $1,059.
In November, the Biden administration also proposed a new rule expanding Medicare and Medicaid coverage to include GLP-1s for weight loss, but it is unclear whether President Donald Trump will follow through.
Aileen Maritato hasn’t given up. This spring, she plans to return to her primary care doctor – not an online pharmacy – to request that he appeal the insurance company’s denial.
A 2021 study found that about 49 percent of healthcare-related denial appeals are successful.
‘It’s definitely ‘worth it to try’, she says.