Xyrem Dosage, forms & strengths
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Xyrem (sodium oxybate) is a central nervous system depressant that is manufactured by Jazz Pharmaceuticals, Inc. It is a sodium salt of the street drug gamma hydroxybutyrate (GHB) that is only available through certified pharmacies enrolled in the Xyrem REMS program. Your healthcare provider must also be registered with the program to prescribe you this medication.
Xyrem is FDA-approved to treat sudden muscle weakness while awake (cataplexy) or excessive daytime sleepiness (EDS) in patients with narcolepsy that are 7 years of age and older.
How does Xyrem work?
Xyrem helps increase the amount of deep sleep you get at night by acting on GHB and GABA receptors. This helps reduce symptoms of narcolepsy such as cataplexy and excessive daytime sleepiness.
Xyrem dosage forms and strengths
- 0.5g/ml oral solution
Xyrem should be started at 4.5g per night by mouth, divided into two doses. Your dose can be titrated in increments of 1.5g per night in two divided doses at weekly intervals until effective. The dose range of Xyrem is 6g to 9g per night, in two divided doses.
The recommended starting dose, titration regimen, and maximum total nightly dosage for pediatric and adolescent patients 7 years of age and older are based on body weight.
Xyrem dosage restrictions
The recommended dose of Xyrem in patients with hepatic Impairment is one-half of the original starting dose per night, divided into two doses.
There is no dose adjustment recommended for patients with renal impairment
How to take Xyrem
- Read the Full Prescribing Information, Drug Information, and Medication Guide that comes with Xyrem.
- Take Xyrem exactly as your healthcare provider tells you. Do not change your dose of Xyrem or stop taking this medication without discussing it with them.
- Xyrem can make fall asleep very quickly without ever feeling drowsy. Some people fall asleep within 5 minutes while most fall asleep within minutes.
- Xyrem is taken in 2 divided nightly doses. You will take the first dose of Xyrem at least 2 hours after eating while in bed. You should lie down immediately after taking your first dose. The second dose of Xyrem is then taken 2.5 to 4 hours later. If you miss the second dose of Xyrem, skip it and wait until the next night to take Xyrem.
Xyrem dosage FAQs
What are the most common possible side effects of Xyrem?
Some common adverse events of Xyrem in clinical trials, when compared to placebo, include:
- Enuresis (bedwetting)
- Loss of appetite
- Weight loss
- Sleep paralysis
- Dry mouth
Xyrem can sometimes cause more serious adverse effects, including:
- Severe hypersensitivity reactions (hives, angioedema, and trouble breathing)
- Suicidal thoughts and behaviors
- Hallucinations and psychosis
- Worsening symptoms of hypertension and heart failure
Contact your healthcare professional for medical advice about any possible side effects you may experience while taking Xyrem. You can report any adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What drug interactions occur with Xyrem?
When Xyrem is taken with other medications, it may change the way they work or increase the frequency and severity of side effects. You should discuss with your doctor whether any of the prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take may interact with this medication, including:
- Divalproex sodium
- Other CNS depressants such as antidepressants, benzodiazepines, muscle relaxers, opioids, and anticonvulsants
Are there any contraindications or precautions with Xyrem?
You should not take Xyrem if you drink alcohol, take sedative-hypnotics, or if you have a rare disorder called succinic semialdehyde dehydrogenase deficiency.
You should use Xyrem with caution if you have:
- History of substance abuse
- Mental illness
- Heart failure or high blood pressure
- Kidney disease
- Sleep apnea or other sleep disorders
- Breathing problems or lung disease
- Liver disease
- A sensitivity to high sodium intake
- Are pregnant, plan on becoming pregnant, or are breastfeeding
Can you take Xyrem while you are pregnant or breastfeeding?
Based on animal studies, there is a risk of fetal harm if Xyrem is used while pregnant. Xyrem should be only used in pregnant women if the possible benefits outweigh the possible risks to the fetus. GHB is found in breast milk when Xyrem is taken by mouth. There is no information on the risk to a breastfed infant or on milk production during lactation. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
Is Xyrem a controlled substance?
Yes, Xyrem is a Schedule III controlled substance that carries a high potential for abuse.
Can you drink alcohol with Xyrem?
No, you should not drink alcohol while on this medication. Combining these 2 CNS depressants can lead to serious side effects such as respiratory depression.
What is the maximum dose of Xyrem you can take?
The FDA-approved maximum dosage of Xyrem is 9g per night, given as two 4.5 g doses.
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