The Only Effective Sleep Medicine Is Way Too Expensive
A friend whom I will call Sally has destroyed her ability to get restful sleep. She takes five separate sleep prescriptions and says she has not slept well in several years
The medications multiplied over time—one drug failed, then another was added, then another.
Now she is trapped in a pharmacological nightmare from which there seems no escape.
A “physician” convinced Sally that bioidentical progesterone causes breast cancer, which is the reverse of the truth, for progesterone suppresses it.
Taking a micronized, bioidentical formulation from a compounding pharmacy in high enough doses at bedtime would likely solve her sleep problems in just a few days. (This is not healthy for men, however, and some women require 800 mg.)
Instead, she takes five dangerous drugs that leave her exhausted and desperate.
Xyrem (sodium oxybate) is the one medication that delivers quality sleep, but obtaining it has become nearly impossible. The drug exists under a restrictive distribution system that makes access difficult, and the price—often exceeding $15,000 per month without insurance—puts it beyond reach for most patients.
It was somehow branded a “date rape” drug.
I have skin in this game. Parkinson’s disease causes neurological sleep interruption, and I wake up four or five times each night. My inquiries among young friends involved in the rave scene turned up no Xyrem, which is for the best because the penalties for possessing it are severe.
I spent a decade on clonazepam (Klonopin) before I realized that the drug had become the problem. Withdrawing from it took months, and I had extreme rebound anxiety during that time.
I suspect that my decade of use permanently damaged my ability to sleep. See HERE for that story.
My current best, albeit imperfect, sleep results occur when I avoid pharmaceutical drugs and use natural approaches. I occasionally—rarely—resort to 1/6th of an indica marijuana gummy.
This works better than the sativa type, which can be agitating and contains more THC and less CBD. This is an imperfect solution that has the same side effects of confusion, progressive tolerance, and escalating doses, just like the damn benzos.
The Foundation: Natural Sleep Solutions
Gentle remedies exist: magnesium supplementation, proper sleep hygiene, stress management, and most important of all, hormone replacement.
A detailed discussion of these approaches appears in the Apocalypse Almanac chapter on good sleep HERE. It emphasizes a crucial point: hormone replacement should always be evaluated first when sleep problems are present.
For women with inadequate progesterone—a common problem even among 40-year-olds—replacing this hormone with micronized, compounded bioidentical progesterone offers an effective, natural solution.
The treatment is so safe that it should be available over the counter. The key is to take it at bedtime and increase the dose until sleep improves. Some women require 1,000 mg. And both testosterone and progesterone protect against breast cancer, contrary to what some physicians tell patients.
With that foundation established, here is the disaster that pharmaceutical companies have created.
Xyrem works but has been suppressed
Xyrem (sodium oxybate) is the one pharmaceutical sleep medication that works without destroying sleep architecture. The drug is extraordinarily effective for narcolepsy and helps with cataplexy (this is a sudden, brief loss of muscle control, often triggered by strong emotions like laughter, joy, or surprise, resulting in weakness from facial drooping to full body collapse. It is a key symptom of narcolepsy.)
Xyrem relieves excessive daytime sleepiness. Patients who take it report restorative sleep, so why is this drug nearly impossible to obtain? The active ingredient is gamma-hydroxybutyrate (GHB), which became notorious as a “date-rape” drug.
Yoho comment: I believe this story was planted to destroy the drug’s marketability.
In 2000, GHB was placed on Schedule I of the Controlled Substances Act, which is for drugs with high abuse potential, no accepted medical use in treatment, and a lack of accepted safety for use even with supervision, like heroin or LSD.
However, sodium oxybate for medical use was classified as Schedule III, with the caveat that illicit use carries Schedule I penalties.
The FDA requires that Xyrem be available only through a Risk Evaluation and Mitigation Strategy (REMS) program. This means that prescribers must be certified, pharmacies must be certified, and patients must be enrolled.
The drug cannot be obtained from retail pharmacies. It must be shipped directly from a single certified pharmacy to enrolled patients.
The pricing is astronomical. Without insurance, Xyrem costs between $5,000 and $21,000 per month, depending on the dose and source. With the GoodRx discount, the price drops to approximately $19,000 per month.
These costs make the drug inaccessible to most patients who need it.
Jazz Pharmaceuticals, which acquired the drug in 2005, raised prices dramatically. The company paid a $20 million fine in 2007 for off-label marketing. A generic version was not approved until 2017, and it is subject to the same REMS restrictions.
It is easy to synthesize and is available on the black market.
If Xyrem were widely available and affordable, it would destroy the market for nearly every other sedative. Pharmaceutical companies have a financial interest in keeping it restricted.
The combination of being Schedule I, restricted distribution, and prohibitive pricing ensures that this effective medication remains out of reach for most patients who could benefit from it.
See more here substack.com
Bold emphasis added
Header image: Getty Images / iStockphoto
Tom
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What is keeping people awake? An agitated mind in most cases. A procession of thoughts that will not slow down or turn off. Most often, the person is not even aware or awake to this ongoing flow of tension and anxiety. Drugs are not the answer. An awake mind is. Awareness to the flow of thoughts slows them down and calms the body.
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