Sodium Oxybate (Oral)

Sodium oxybate is a strictly controlled oral medicine which is taken at night to induce sleepiness and manage the symptoms of narcolepsy.

Overview

Sodium oxybate is designed to treat cataplexy and daytime sleepiness in people with narcolepsy. Narcolepsy is a sleep condition which causes sudden attacks of deep sleep or uncontrollable desire for sleep. Cataplexy is a symptom of narcolepsy, and it causes muscle weakness or paralysis.

Sodium oxybate, which is known in the US under brand name Xyrem, is an oral medicine provided in solution form. It is designed to be taken at night since it induces sleep, and should be taken on an ongoing basis to manage the symptoms of narcolepsy. It is not a cure for narcolepsy, and patients who are prescribed the drug should continue to take it even after they feel well due to the relief of narcolepsy symptoms.

There are important warnings associated with sodium oxybate. Firstly, the drug is a GHB (gamma-hydroxybutyrate), a street drug which has frequently been abused. Sodium oxybate is therefore strictly controlled and only available via a restricted distribution program known as Xyrem REMS. Healthcare providers must enroll patients in the Xyrem REMS program and send prescriptions to the central Certified Pharmacy, which is the only pharmacy in the US which can fill Xyrem prescriptions. The Certified Pharmacy then ships the prescription overnight and arranges delivery of refills directly to you thereafter.

Sodium oxybate is strictly controlled because it is a CNS depressant and can cause life-threatening side effects if taken incorrectly or abused. Individuals who take it to manage the symptoms of narcolepsy should not drink alcohol and make their doctor aware if they are taking other medications which are CNS depressants.

Condition(s) treated?

  • Cataplexy
  • Daytime sleepiness

Type of medicine?

  • Hydroxybutyrate
  • CNS depressant

Side Effects

Sodium oxybate can cause death if taken in large quantities. If you notice any of the following symptoms of overdose, seek emergency medical care:

  • Slow or irregular heartbeat
  • Alternating between shallow and deep breathing
  • Not breathing
  • Coma
  • Depressed consciousness
  • Confusion
  • Agitated combative state
  • Extreme drowsiness, or sleepiness or weakness
  • Lightheadedness, dizziness or fainting
  • Bluish lips or skin
  • Not breathing
  • Slowed mental and physical activity
  • Inability to hold urine or bowel movements
  • Increased sweating
  • Convulsions
  • Muscles weakness or aches
  • Shakiness
  • Unsteady walk
  • Trembling
  • Problems with muscle control or coordination
  • Shivering
  • Vomiting
  • Weak or feeble pulse

Sodium oxybate poses a risk of a wide range of side effects, some of which are mild and don't usually require treatment, while others are serious and need urgent medical attention. If you notice any of the following serious side effects, check with your doctor immediately or seek emergency care:

  • Bloating of face, arms, hands, legs or feet
  • Tingling in hands or feet
  • Sudden, rapid weight gain
  • Unusual weight loss
  • Headache
  • Anxiety
  • Depression
  • Thoughts of harming yourself or of suicide
  • Confusion or memory problems
  • Hallucinations
  • Loss of contact with reality
  • Blurred vision
  • Snoring or sleep apnea
  • Extreme drowsiness during the day
  • Troubled swallowing
  • Troubled breathing when at rest
  • Tightness in the chest
  • Chest pain or discomfort
  • Pounding or fast heartbeat
  • Noisy or rattling breathing
  • Decreased urine output
  • Bedwetting
  • Dizziness
  • Hives, rash or itching
  • Redness of the skin
  • Sweating
  • Joint pain, swelling or stiffness
  • Sleepwalking
  • Abnormal dreams

The following side effects are minor and don't require medical attention unless they cause major discomfort or inconvenience. They may dissipate over time as the body adjusts to the medicine:

  • Burning, crawling, itching, numb or prickling sensations
  • Confusion about identity, time and place
  • Feeling drunk
  • Forgetfulness
  • Irritability
  • Diarrhea
  • Mild pain or discomfort in stomach or upper abdomen
  • Decreased appetite
  • Difficulty with moving
  • Mild pain or stiffness in muscles

If you notice any other side effects not listed here, consult your doctor as soon as possible. You could also report side effects to the FDA.

Dosage

The amount of sodium oxybate a patient takes will vary depending on factors such as their age and other medical conditions that they suffer from. Always follow your doctor's instructions. The following are average doses and are provided as a guideline only:

Adults

  • 2.25 grams taken at bedtime and repeated once during the night
  • May be increased as needed according to doctor's instructions
  • Maximum dose 9 grams per night

 Children

  • Use and dose determined by a doctor

How to take sodium oxybate

Since sodium oxybate only works for a short time, two doses are needed each night. The first dose should be taken only once you are in bed and ready to go to sleep, since it acts on the body very quickly. The second dose should be taken between two and half and four hours later; you should set an alarm to wake you in order that you can take the medicine at the appropriate time.

Once again, the second dose should only be taken while you are in bed and ready for sleep. If you wake earlier than your alarm, you may take the second dose of sodium oxybate as long as at least two and half hours have passed since the first dose. Remember to turn off your alarm so that you are not disturbed again later.

Sodium oxybate should be consumed on an empty stomach, so avoid food for at least two hours before going to bed and taking the medicine.

How to prepare sodium oxybate solution

Sodium oxybate is administered in solution form (liquid) and should be mixed with water before being taken orally. The medicine is provided in a bottle with a measuring device which allows the correct dosage to be measured out, and dosing cups in which the solution should be made up. Each dose should be mixed with 2 ounces (60 ml) of cold water; do not mix it with juice, milk, soft drinks or any other liquid.

The dosing cups are provided with caps so that they are protected from spills or contamination until you are ready to take them. The caps are child-resistant, so be sure to turn them until the lock. Prepared solutions should be used within 24 hours of being mixed; if you have unused medicine which was mixed over 24 hours ago, discard it and prepare a fresh mixture when required.

Missed doses

If you miss a dose of sodium oxybate, only take it if it is a suitable time to do so, i.e. at night and when you plan to sleep for several more hours. For example, if you missed taking your second dose during the night and only realized upon waking in the morning, do not take the missed dose. Instead, simply skip it and resume your normal dosing schedule the following night.

Interactions

The following medicines should never be taken with sodium oxybate. If you are taking any of them, your doctor will either choose not to prescribe sodium oxybate, or they may change the other medicines you take. Always follow your doctor's instructions so as to avoid serious drug interactions:

  • Carbinoxamine
  • Chloral Hydrate (Somnote)
  • Diphenhydramine (included in many allergy, cold and flu medicines)
  • Doxylamine (Unisom, Nytol Maximum Strength, Aldex AN)
  • Eszopiclone (Lunesta)
  • Ethchlorvynol (Placidyl)
  • Hydroxyzine (Vistaril, Atarax, Hyzine, Vistaject-50, Rezine, Vistacon, Vistacot, Vistazine)
  • Promethazine (Phenergan)
  • Ramelteon (Rozerem)
  • Zaleplon (Sonata)
  • Zolpidem (Ambien, Edluar, Intermezzo, Zolpimist)
  • Zopiclone

There are also many more medicines which interact with sodium oxybate, but which may still be used concurrently if the benefits of both drugs far outweigh the risk of harmful interaction. Your doctor may adjust the dosage of sodium oxybate or your other medicines to minimize the risk of side effects. Make sure your doctor is aware of all the medicines you are currently taking so that they can identify potential interactions.

CNS depressants

Any medicines which act on the central nervous system to induce sleepiness or drowsiness should be avoided when taking sodium oxybate. These types of drugs can heighten the risk of slow or irregular breathing, seizures, unconsciousness, and death when taken with sodium oxybate. Make sure your doctor knows about all medications you are taking that have these effects; this includes:

  • Cold and flu medicines
  • Opioid painkillers
  • Sedatives
  • Muscle relaxants
  • Seizure medicines
  • Antidepressants
  • Anti-anxiety medicines
  • Anti-psychotic medicines

Your doctor will probably direct you to stop taking sodium oxybate while you are taking any of the medicines outlined above. Always follow your doctor's instructions.

Some over-the-counter (OTC) medicines, particularly antihistamines and cold and flu medicines, can contain ingredients which depress the central nervous system. Always check with your doctor before taking any OTC drugs. They will be able to recommend OTC treatments which do not contain ingredients that induce drowsiness.

Alcohol consumption

Alcohol is a CNS depressant and should, therefore, be avoided while taking sodium oxybate. Doing so could slow or stop your breathing, cause seizures, unconsciousness or coma, and even lead to death. You should not consume any alcohol while taking this medicine. If you need help in ceasing your alcohol consumption, ask your doctor for advice.

Warnings

Pregnancy and breastfeeding

Sodium oxybate is an FDA pregnancy category C drug, which means that it should only be used during pregnancy if absolutely necessary. Animal studies have demonstrated a risk to the fetus, while data from a limited number of human pregnancies suggest that there is a risk of spontaneous abortion associated with the drug when it is taken during the first trimester. For this reason, the drug should only be used if the benefits to the mother far outweigh potential risks to the fetus.

It is not known whether sodium oxybate is excreted in human breast milk, or if the drug could pose a risk to nursing infants. For this reason, breastfeeding is not recommended while sodium oxybate is being taken.

Use by other people

Sodium oxybate is a dangerous substance if misused. It is highly regulated and restricted, and should only ever be used by the person it is prescribed to. If others take the medicine, they risk developing breathing problems, seizure, coma or death.

History of depression

Sodium oxybate can cause mental depression, and should, therefore, be used with great caution in individuals with a history of depression. Make sure your doctor knows about your mental health history because you may be at an increased risk of depression when taking sodium oxybate. If you have had a history of suicidal ideation or self-harm, you may also be more vulnerable to these when taking sodium oxybate.

Breathing problems

If you suffer from breathing or lung problems, sodium oxybate may make these problems worse because it can slow down breathing. Make sure your doctor is aware of your medical history, particularly if you have a history of or are currently suffering from:

History of drug or alcohol abuse

Sodium oxybate can cause dependency, and the risk of dependency is increased in people with a history of drug or alcohol addiction, misuse or abuse. Make sure your doctor knows about any substance addictions you have had in the past, as you may not be able to take sodium oxybate.

Individuals who are currently struggling with alcohol addiction should also let their doctor know. Alcohol cannot be consumed with sodium oxybate as doing so could cause serious, life-threatening side effects. If you feel that you would struggle to stop drinking alcohol while taking sodium oxybate, ask your doctor for help with addiction.

Heart failure, hypertension and kidney disease

Sodium oxybate contains sodium, which may cause fluid retention. In individuals with heart failure, hypertension (high blood pressure) and kidney disease, all of which can cause fluid retention and edema, sodium oxybate could worsen the condition. Make sure your doctor knows if you suffer from these conditions as they may choose not to prescribe sodium oxybate or they may prescribe lower doses to minimize the risks.

Succinic semialdehyde dehydrogenase deficiency

Individuals with, or with a history of, succinic semialdehyde dehydrogenase deficiency should make sure their doctor knows. This rare metabolism disorder is inherited and causes a buildup of substances in the body which can lead to developmental delays. Sodium oxybate can be extremely harmful to people with this condition and should therefore not be prescribed.

Liver disease

In people with liver disease, sodium oxybate will be processed and removed from the body at a much slower rate than normal. This means that the substance will stay in the body for longer and could, therefore, increase the risk of side effects. Depending on the severity of your liver disease, your doctor may not prescribe sodium oxybate at all, or they may prescribe very low doses to minimize the risk of side effects.

Surgeries

You should let your doctor or dentist know that you take sodium oxybate before undergoing any type of surgery, no matter how minor. Anesthetics and other medicines used during surgeries could increase the risk of respiratory depression, seizures and coma. You may be advised to stop taking sodium oxybate for a few days before a surgery to minimize this risk.

Storage

Sodium oxybate is provided in a closed bottle and should be stored in this container at room temperatures and away from heat, moisture and direct light. It should also be kept from freezing.

Sodium oxybate which has been mixed with water in preparation for consumption should be stored in the dosing cups provided with the lid securely fastened. It can be stored for up to 24 hours before it should be disposed of.

Always keep sodium oxybate in childproof containers away from children and pets.

Do not store outdated medicine. Instead, dispose of it by pouring it down the sink. Then, use a marker pen to cross out the label on the bottle and dispose of the bottle in the trash. Check with your healthcare provider about appropriate disposal of sodium oxybate if you're unsure.

Summary

Sodium oxybate is a treatment for daytime sleepiness and cataplexy, both of which are symptoms of narcolepsy. The drug is not necessarily a cure for narcolepsy, but it can help to reduce attacks of extreme tiredness or deep sleep during the day.

In the US, sodium oxybate is known under the brand name Xyrem and is only available with a doctor's prescription and referral to the Xyrem REMS program. The drug has been misused in the past and is extremely dangerous if taking in high doses, with alcohol or with certain other medicines. For this reason, it's only available through this restricted distribution program in which prescriptions are filled by the central Certified Pharmacy and shipped directly to patients.

Sodium oxybate is provided in liquid form which is designed to be diluted with water and taken orally. It induces sleepiness and should be taken at night, once the patient is in bed and ready to go to sleep. It works for only a short time in the body, and two doses are needed each night. The patient should prepare both dosages before they go to bed, using the capped dosing cups provided with the medicine. They take the first dose when they are ready to sleep, and the second between two and half and four hours later. It is important to set an alarm in order to be able to wake up and take the second dose.

This drug is a central nervous system (CNS) depressant and so the biggest risks associated with it are slow breathing, seizures, unconsciousness and death. These risks are greatly increased if patients also take other CNS depressants, such as sedatives, anti-anxiety medications, sleeping pills, cold, flu and allergy medicines, antidepressants. It's also incredibly important to avoid alcohol while taking this drug; doing so could cause life-threatening complications.

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Last Reviewed:
December 24, 2017
Last Updated:
April 05, 2018