Xyrem Oral Solution 500Mg Drug Medication Dosage Information
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Xyrem: Oral solution (500mg)

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What is this Medicine?

SODIUM OXYBATE (SOE dee um OX i bate) is used to treat excessive sleepiness and cataplexy in patients with narcolepsy. Cataplexy causes a sudden muscle weakness due to a strong emotional response. This medicine is not available in retail pharmacies. Your doctor will enroll you in a program that will provide the drug to you.

In-Depth Information
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Xyrem 500mg/ml Solution

NDC: 621610008
  • Prescription Required
  • Federally Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Cataplexy, Narcolepsy

Xyrem 500mg/ml Solution

Reported Side Effects for Xyrem 500mg/ml Solution

Irritability Incidence:
<3.0%*
Severity: MILD
Onset: DELAYED
Sleep-Walking Incidence:
<6.0%*
Severity: MILD
Onset: EARLY
Depression Incidence:
<7.0%*
Severity: MODERATE
Onset: DELAYED
Shaking Incidence:
<5.0%*
Severity: MILD
Onset: EARLY
Muscle Cramps Incidence:
<2.0%*
Severity: MILD
Onset: DELAYED
Fluid Retention Incidence:
<3.0%*
Severity: MODERATE
Onset: DELAYED
Excessive Sweating Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Drowsiness Incidence:
1.0-8.0%*
Severity: MILD
Onset: EARLY
Paresthesias Incidence:
1.0-3.0%*
Severity: MILD
Onset: DELAYED
Dry Mouth Incidence:
1.0-2.0%*
Severity: MILD
Onset: EARLY
Stomach Pain Incidence:
1.0-3.0%*
Severity: MILD
Onset: EARLY
Nervousness Incidence:
1.0-5.8%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
2.0-11.0%*
Severity: MILD
Onset: EARLY
Confusion Incidence:
3.0%*
Severity: MODERATE
Onset: EARLY
Loose Stools Incidence:
3.0-4.0%*
Severity: MILD
Onset: EARLY
Uncontrolled Urination Incidence:
3.0-7.0%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
8.0-20.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
9.0-15.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Daily Life Interactions for Xyrem 500mg/ml Solution

Elements of your daily lifestyle may have an effect on the medications you are taking. Drug interactions can result in unwanted side effects, reduce the effectiveness of your medicine or possibly increase the action of a particular medicine.

Severe Lifestyle Interaction
Alcohol and Xyrem 500mg/ml Solution(Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb))
Alcohol and Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb)(Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb))
Do not drink Alcoholic beverages while taking Sodium Oxybate (Xyrem). Alcohol can cause drowsiness, mental impairment and fatigue which can decrease the effectiveness of Xyrem treatment. In addition, taking Alcohol with Sodium Oxybate (Xyrem) could result in serious side effects such as confusion, loss of coordination, muscle twitching or weakness, sweating, tremor, seizures or difficulty breathing.
Severe Lifestyle Interaction
Food and Xyrem 500mg/ml Solution(Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb))
Food and Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb)(Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb))
Food significantly reduces the effectiveness of Sodium Oxybate. You should take your doses on an empty stomach. This means you should try to eat well before (i.e., several hours prior) going to sleep and taking the first bedtime dose. You should eat your evening meal and take your doses at roughly the same times daily to minimize any effects of food on your response to Sodium Oxybate treatment.
Major Lifestyle Interaction
Caffeine-containing Foods/Beverages and Xyrem 500mg/ml Solution(Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb))
Caffeine-containing Foods/Beverages and Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb)(Sodium Oxybate (Gamma Hydroxybutyrate Or Ghb))
Limit caffeine intake (examples: coffee, teas, colas, chocolate and some herbal supplements) while taking Stimulant medicines. Stimulants include drugs used for weight loss, narcolepsy, and Attention-Deficit-Hyperactivity Disorder (ADHD). Examples include: Amphetamine, Adderall, Concerta, Cylert, Dextroamphetamine, Dexedrine, Metadate, Provigil, Ritalin, or Xyrem. Also avoid medicines containing additional Caffeine whenever possible. Side effects from Psychostimulants may get worse if you take excessive Caffeine. Taking a high amount of Caffeine can increase the risk of nausea, nervousness, palpitations, problems with sleep, rapid heartbeat, or other side effects.
Pregnancy & Lactation Information
FIRST Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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