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Dosage Disclosure Denied For Sleep Remedy’s “Perfect Blend”

A new product, Dream Water, is designed to help one relax, fall asleep and improve the quality of sleep using the “perfect blend” of all-natural ingredients melatonin, GABA and 5-HTP (tryptophan).

A single-dose 2.5-ounce bottle retails for $2.99. They also offer a more dilute formulation in an 8-ounce bottle. They suggest drinking half a bottle, keeping it at your bedside, and drinking more if you wake up during the night.

What dosage will you get from half a bottle? From a whole bottle? There’s no way to know. They offer a money-back guarantee, free shipping, free samples, and lots of testimonials. But they refuse to disclose how much of what is in their product.

The DSHEA only permits structure and function claims like “supports prostate health,” but this product is clearly being promoted as a remedy for insomnia. The “Quack Miranda warning” is not displayed on the home page, but the “Dream Responsibly” page says “These statements have NOT been evaluated by the Food and Drug Administration. This product is NOT intended to diagnose, treat, prevent or cure any disease.”

Is it legal to sell this as a remedy for insomnia? I guess the legality depends on whether you define insomnia as a disease. Maybe they define it as an impairment in a function that needs supporting. Maybe they can get away with it.

What’s the Scientific Evidence?

It’s a “perfect blend” of three ingredients that they say produce relaxation and sleep. Do these three natural medicines really work for insomnia? I looked up the ingredients in The Natural Medicines Comprehensive Database.

  • Melatonin: For primary insomnia, melatonin reduces the time it takes to fall asleep by 12 minutes but does not improve sleep efficiency. There have been reports of adverse effects like elevated blood pressure and increased bleeding tendency in patients taking Coumadin. There are concerns about possible interactions with 11 categories of drugs, from antidiabetes drugs to contraceptives. The Dream Water website doesn’t mention any of this.
  • Tryptophan (5-HTP) is rated as “possibly unsafe” and there is “insufficient reliable evidence to rate” effectiveness for insomnia. There is a long list of possible interactions with several other categories of drugs.
  • GABA – insomnia is not even on the NMCD’s list of things that “people use this for.” They found insufficient reliable information about safety and effectiveness to even give it a rating. We don’t think GABA even crosses the blood-brain barrier.

Inquiring Minds Want to Know

I wrote their representative and asked:

I’m wondering about the dosage. Can you tell me how much melatonin, tryptophan and GABA are in each bottle? Have any placebo-controlled studies been done?

She answered:

Unfortunately we cannot share specifics as the formula is proprietary. We also don’t have any formal placebo testing as of yet.

I replied:

So you’re suggesting that I use something with an unknown amount of active drugs, something that has not been properly tested, and that I simply take your word for it that the company has found a “perfect blend” without knowing how they found it or what exactly they found? No thanks, I’m not that gullible.

She answered:

I completely understand your concerns.

Gee, knowing that she understands makes me feel so much better.

Double Standard?

ConsumerLab tests dietary supplements to assess purity and to determine if they contain the amount of ingredient claimed on the container label. How can they determine whether the amount in the container matches amount listed on the label if there is no amount listed on the label? And if they test Dream Water and measure the amounts of the 3 components, wouldn’t that reveal the proprietary secret?

I wonder about the folks who are selling Dream Water. If they had an infection, would they be willing to take a new pharmaceutical product that was not FDA approved, that was an untested mixture of 3 prescription antibiotics, two of which had not been proven effective for that infection? Would they buy it if the dosage of the ingredients was kept secret, and would they be willing to trust the word of some unidentified person in the pharmaceutical company that it was an optimal mixture (someone who was claiming to somehow know it was optimal without bothering to test it)?

For crying out loud, even my food labels specify how many grams of fat are in a serving!

*This blog post was originally published at Science-Based Medicine*

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