Asleep thanks to the side effect

The brown bottle has been sitting unused in the bathroom for a while. Dream Juice, it says. It “stimulates natural sleep with 7 soothing herbs.” The herbs are oats, hops, mistletoe, hawthorn, horse chestnut, passion flower and nightcap. Under ‘composition’ the first ingredient listed is ‘doxylamine’, which again sounds less natural. “Often used as a sedative and used for allergies,” says the package insert.

Why did I purchase this? To fall asleep easier. There are many good reviews on the internet and I read little about side effects. Why haven’t I used it yet? Because I don’t quite trust it anyway. I don’t like quackery. And this is not a trusted brand, available at drugstores and pharmacies. You can only buy it online from a company called Dromenwinkel, based in the Czech Republic.

A bit of googling yields varying sounds. Influencer Estelle Cruijff and daughter Joëlle Gullit are ecstatic in a podcast. “Fantastic stuff, I immediately ordered the largest bottle,” says Gullit, who claims to be unsponsored. The largest bottle contains half a liter and costs 56.95 euros. Cruijff: “I love it because you sleep so deeply.” Ex-vlogger Monica Geuze was less satisfied: “I must say that I slept very restlessly. Every sound really woke me up.”

Still: why not give it a try? Better that than getting addictive benzodiazepines through your GP. According to the Pharmaceutical Figures Foundation, 1.3 million Dutch people used these drugs in 2022. There are probably more, because benzodiapines (such as diazepam, alprazolam (xanax), lorazepam, oxazepam) are also available without a prescription from foreign web shops. And sleep problems are common. One in four Dutch people aged twelve and older suffer from it, according to CBS figures. They have difficulty falling asleep or staying asleep or they wake up too early.

Melatonin gummies

“One of the reasons that people do not report insomnia to a doctor is that they are afraid of being given medications to which they could become addicted,” says Angelique Pijpers, neurologist-somnologist and medical head of the Center for Sleep Medicine Kempenhaeghe. “Then sometimes they prefer to mess around with something themselves.” Pijpers treats problematic insomnia, in which people lie awake more than three nights a week for a longer period of time, with negative consequences for daytime functioning. Of her new patients, an estimated 30 percent use a sleeping aid that they can buy without a prescription, says Pijpers. This often concerns herbs or homeopathic remedies. Some use cannabis oil or DreamSap. The most popular seems to be melatonin.

Melatonin is not only available at the drugstore, but even at the supermarket. It is a hormone, a body’s own substance. “Most mammals produce melatonin in the pineal gland during part of the evening and night,” says Pijpers. “In diurnal animals, like us humans, melatonin prepares the body for sleep.” According to her, it may be useful to take melatonin for a short time if the sleep rhythm is disturbed, for example due to jet lag. It is not recommended to use it for a long time, or to increase the dose if it no longer works. “If you use melatonin on your own initiative, you don’t know whether you are using it for the right reason. The advice in the package leaflet about time of intake and dosage is often too general. This can confuse your biological clock.”

It is not recommended to use melatonin for a long time, or to increase the dose if it no longer works.

According to Pijpers, the effectiveness of melatonin for poor sleep has not been sufficiently proven – except for people over 55 and children with autism. Possible side effects include headache and drowsiness. Pijpers: “And there is no good research about what it does to you in the long term.” Yet parents also give melatonin to (non-autistic) children on their own initiative, she knows. There are even fruit-flavored melatonin gummies available. “Children receive these before going to sleep, or when they get in the car on the way to Spain. I would say don’t do that. The side effects also seem to be less likely in children, but we do not know for sure. And you don’t give your child any other hormones either.”

Hallucinations

Back to the bottle in my bathroom. DroomSap has the special feature that it contains doxylamine in addition to herbs. Pijpers: “That is an antihistamine that was used in the last century against allergies. Drowsiness is a side effect. This side effect is used to accelerate sleep.” In addition, doxylamine has an effect on the neurotransmitters that transmit signals from muscles to nerves. “As a result, side effects such as dizziness, memory problems and increased eye pressure are also possible.”

In an online message to broadcaster Max, pharmacist Anke Lambooij of the Institute for Responsible Medicine Use mentions “dizziness, dry mouth and eyes and confusion” as possible side effects of DroomSap, and for the elderly also “hallucinations, delirium and dementia”.

“When you read that you think: that is poison,” says John de Wit of producer Dromenwinkel. He sometimes gets tired of the “ghost stories” on the Internet, he says. DroomSap was not allowed to be sold in the Netherlands for a long time because doxylamine was not a registered medicine. For that reason, Dromenwinkel was first located in Belgium and now in the Czech Republic. But DroomSap, says De Wit, is made in a medicine factory in the Netherlands. Dromenwinkel is “a small Dutch family business”. No, the family name is not allowed in the newspaper, “we don’t want any hassle.” De Wit is an independent consultant. At Dromenwinkel he handles pharmaceutical and medical matters, as well as marketing and quality assurance.

The company is not looking for publicity, says De Wit. “We grew by word of mouth.” He does not want to say how big, but that there is an “annual growth of 30 to 60 percent”. DroomSap has been around for fifteen years, previously also under the name Sleep-Juice. It is freely available in the US, where it is called Sambrosa Night Syrup. The active ingredient doxylamine is also freely available in many other countries, says John de Wit. The Hoggar Night (German) and Dormidina (Spanish) pill strips contain much more doxylamine (25 milligrams) per pill than a daily dose of DroomSap (6.52 milligrams). According to De Wit, this shows that there is nothing wrong with doxylamine. “It cannot be the case that a drug is safe in one country and not in another.”

DroomSap has been around for fifteen years, previously also under the name Sleep-Juice.

Dheyna Plugge (27) from Rijswijk has been taking the drink for five months. It was recommended to her by a friend who works irregular shifts like her, and she knows more people who use it. She takes a spoon two to three times a week, “it depends on how busy my head is.” The dosage is important, she says. “If you know you have a short night, you should not take four milliliters because then you will still be drowsy in the morning. I had one occasion where I didn’t wake up at all, when I was driving to work in the morning even though I was off that day and had to go somewhere else. I always take two milliliters on short nights and three or four if I know I can sleep for a long time.”

Strawberry flavored powders

In October 2023, something changed regarding doxylamine in the Netherlands. The Medicines Evaluation Board (CBG) issued a marketing authorization for powders containing 12.5 or 25 milligrams of doxylamine, for short-term treatment of occasional insomnia, by prescription only. This decision means, the MEB said, that “the benefits (efficacy) of the medicine outweigh the disadvantages (side effects, risks).” The powders, with strawberry flavor, can now be prescribed by doctors in the Netherlands and sold by pharmacies.

According to John de Wit, Dromenwinkel achieved this together with the Spanish pharmaceutical company Geiser. Does this mean that doxylamine as a sleeping aid will now also be marketed in the Netherlands? No, he thinks, because it can only be provided with a prescription. “That makes it economically impossible. Producing and packaging already costs more than the insurance is willing to pay.” So ‘legalization’ does not yield anything for Dromenwinkel? “Just that I can now say with dry eyes that doxylamine is registered as a sleeping aid in the Netherlands.”

It can be confusing for the sleepless consumer. Why is a drug like melatonin available at the drugstore and not DroomSap? This is also not without controversy for melatonin. “I would prefer to see more guidance on melatonin use,” says pharmacist Anke Lambooij. “You have to ensure that people understand the risk and know when it is better to go to the doctor.” She thinks it is completely wrong that melatonin is also available at the supermarket. “It is not an innocent drug. You do have that suggestion if it is next to the Smarties.” DroomSap advises against them, despite the low dose of doxylamine. “I see that as an outdated drug with many side effects. Doxylamine is also contained in a medicine against morning sickness (daily dose 20 milligrams). You are not allowed to drive while using this drug on a daily basis. And if you use it occasionally, the advice is not to drive a car for the next three days.”

Online behavioral therapy

But isn’t a spoonful of DroomSap preferable to addictive benzodiazepines? Lambooij: “It is especially difficult to stop taking benzodiazepines because you sleep less well for a while after stopping. We do not know how addictive they are for melatonin and doxylamine, this has not been studied. I prefer a danger that we know and know what we can do about it. Of course, you would prefer not to use sleeping pills at all. If there really is no other option, I would rather take a benzodiazepine for one or two days – I find that far preferable to substances that are in a gray area.”

Neurologist-somnologist Angelique Pijpers: “If you have problematic insomnia and you want to try something, melatonin, herbs and homeopathic remedies have the least chance of side effects.” But efficacy has not been demonstrated. According to her, the best remedy for insomnia is cognitive behavioral therapy. “Sleep training can reduce the signal transmission that makes people overly alert.” The treatment is not widely available and is not always reimbursed. She therefore advocates “accessible online behavioral therapy” for poor sleepers. “If there is, fewer people will turn to medication.”

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