Fibromyalgia and Narcolepsy Drug Sodium Oxybate

Fibromyalgia is a chronic pain condition that is typically manifested as widespread pain, impairment of daily living functions, sleep disturbance and lack of sleep, presence of typical tender points over the body etc. There are other symptoms such as non-restorative sleep and fatigue.

There are several studies that show that a drug approved for use in a condition called Narcolepsy may help patients with sleep and fatigue problems in fibromyalgia.

The drug in question is called sodium oxybate. Studies have shown sodium oxybate to reduce non-restorative sleep abnormalities.

To date, only one drug, pregabalin, has been approved for the treatment of fibromyalgia. There is a need to expand the pharmacologic options.

What is sodium oxybate?

Sodium oxybate is a metabolite of gamma aminobutyric acid and is approved by the US Food and Drug Administration (FDA) for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy.

In narcolepsy this drug consolidates fragmented sleep, increases duration of deep or slow-wave sleep and reduces night-time awakenings.

In one of the late stage clinical trials with sodium oxybate in fibromyalgia 573 patients with fibromyalgia who fulfilled the American College of Rheumatology criteria were enrolled. They were randomly assigned to three groups with one receiving 4.5 g Sodium Oxybate, one receiving 6g Sodium Oxybate and one group receiving placebo or dummy pills.

After the study patients were assessed for pain reduction, tenderness at the trigger or tender points, sleep quality, fatigue, health-related quality of life and subject’s own assessment of improvement and wellbeing.

Results from the study showed that pain, sleep and other symptoms associated with fibromyalgia improve significantly with sodium oxybate. Around 42% reported over 30% pain reduction with 4.5g sodium oxybate while 51.4% reported over 30% pain reduction with 6g sodium oxybate.

Sleep improved by 20% with 4.5 g sodium oxybate and 25% for 6g sodium oxybate as measured by Jenkins sleep scale.

Both pain relief and sleep improvement with the drugs were significantly greater than with dummy pills or placebo. Patients on sodium oxybate, however, suffered from some common side effects including nausea, dizziness, vomiting, muscle spasms and leg swelling or edema.

2 Comments on “Fibromyalgia and Narcolepsy Drug Sodium Oxybate”

  1. Does this drug really help with the pain and sleepless nights. How do you know this drug is safe and it really helps. Will this drug make you depressed?

    1. I was in a trial for it years ago and it didn’t help with the pain or sleep. It was also a nuisance because you have to set an alarm to go off in the middle of the night since you have to take it in two doses. I had also had very bad dreams while taking it that is when I did manage to get to sleep and I didn’t get very much sleep at all. It also caused a lot of problems for my husband with the alarm going off and waking him up. I can’t remember if it made me any more depressed or not but it probably did. In the end I ended up asking my doctor to take me off of it because I just couldn’t handle it anymore and it didn’t seem to be doing anything for me.

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