Sodium oxybate (patient information)

Sodium oxybate (patient information)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

Disclaimer

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Black Box Warning

CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND MISUSE AND ABUSE. See full prescribing information for complete Boxed Warning. Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients. Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants [see Warnings and Precautions (5.1)]. Xyrem® (sodium oxybate) is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions (5.2)]. Because of the risks of CNS depression, abuse, and misuse, Xyrem is available only through a restricted distribution program called the Xyrem Success Program®, using a centralized pharmacy. Prescribers and patients must enroll in the program. For further information go to www.XYREM.com or call 1-866-XYREM88® (1-866-997-3688) [see Warnings and Precautions (5.3)].

Overview

Sodium oxybate (patient information) is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the treatment of ��cataplexy in narcolepsy and excessive daytime sleepiness (EDS) in narcolepsy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Sodium oxybate (patient information) FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium oxybate (patient information) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium oxybate (patient information) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Sodium oxybate (patient information) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Sodium oxybate (patient information) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium oxybate (patient information) in pediatric patients.

Contraindications

• Xyrem is contraindicated in patients being treated with sedative hypnotic agents.
• Patients should not drink alcohol when using Xyrem.
• Xyrem is contraindicated in patients with succinic semialdehyde dehydrogenase deficiency. This is a rare disorder of inborn error of metabolism variably characterized by mental retardation, hypotonia, and ataxia.

Warnings

CENTRAL NERVOUS SYSTEM (CNS) DEPRESSION AND MISUSE AND ABUSE. See full prescribing information for complete Boxed Warning. Xyrem (sodium oxybate) is a CNS depressant. In clinical trials at recommended doses obtundation and clinically significant respiratory depression occurred in Xyrem-treated patients. Almost all of the patients who received Xyrem during clinical trials in narcolepsy were receiving central nervous system stimulants [see Warnings and Precautions (5.1)]. Xyrem® (sodium oxybate) is the sodium salt of gamma hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death [see Warnings and Precautions (5.2)]. Because of the risks of CNS depression, abuse, and misuse, Xyrem is available only through a restricted distribution program called the Xyrem Success Program®, using a centralized pharmacy. Prescribers and patients must enroll in the program. For further information go to www.XYREM.com or call 1-866-XYREM88® (1-866-997-3688) [see Warnings and Precautions (5.3)].

Central Nervous System Depression

Xyrem is a central nervous system (CNS) depressant. Alcohol and sedative hypnotics are contraindicated in patients who are using Xyrem. The concurrent use of Xyrem with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with Xyrem is required, dose reduction or discontinuation of one or more CNS depressants (including Xyrem) should be considered. In addition, if short-term use of an opioid (e.g. post- or perioperative) is required, interruption of treatment with Xyrem should be considered.

Healthcare providers should caution patients about operating hazardous machinery, including automobiles or airplanes, until they are reasonably certain that Xyrem does not affect them adversely (e.g., impair judgment, thinking, or motor skills). Patients should not engage in hazardous occupations or activities requiring complete mental alertness or motor coordination, such as operating machinery or a motor vehicle or flying an airplane, for at least 6 hours after taking the second nightly dose of Xyrem. Patients should be queried about CNS depression‑related events upon initiation of Xyrem therapy and periodically thereafter [see Warnings and Precautions (5.3)].

Abuse and Misuse

Xyrem is a Schedule III controlled substance. The active ingredient of Xyrem, sodium oxybate or gamma-hydroxybutyrate (GHB), is a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of Xyrem, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (e.g., assault victim). Because illicit use and abuse of GHB have been reported, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of GHB (e.g. increase in size or frequency of dosing, drug-seeking behavior, feigned cataplexy) [see Warnings and Precautions (5.3) and Drug Abuse and Dependence (9.2)].

Xyrem Success Program

Because of the risks of central nervous system depression and abuse/misuse, Xyrem is available only through a restricted distribution program called the Xyrem Success Program.

Required components of the Xyrem Success Program are:

Use of a centralized pharmacy Healthcare Providers who prescribe Xyrem must complete the enrollment forms and comply with the requirements. To receive Xyrem, patients must understand the risks and benefits of Xyrem. Further information is available at WWW.XYREM.COM or 1-866-XYREM88® (1-866-997-3688).

Respiratory Depression and Sleep-Disordered Breathing

Xyrem may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses, life-threatening respiratory depression has been reported [see Overdosage (10)].

In a study assessing the respiratory-depressant effects of Xyrem at doses up to 9 g per night in 21 patients with narcolepsy, no dose-related changes in oxygen saturation were demonstrated in the group as a whole. One of the four patients with preexisting, moderate-to-severe sleep apnea had significant worsening of the apnea/hypopnea index during treatment.

In a study assessing the effects of Xyrem 9 g per night in 50 patients with obstructive sleep apnea, Xyrem did not increase the severity of sleep-disordered breathing and did not adversely affect the average duration and severity of oxygen desaturation overall. However, there was a significant increase in the number of central apneas in patients taking Xyrem, and clinically significant oxygen desaturation (≤55%) was measured in three patients (6%) after Xyrem administration, with one patient withdrawing from the study and two continuing after single brief instances of desaturation. Prescribers should be aware that increased central apneas and clinically relevant desaturation events have been observed with Xyrem administration.

In clinical trials in 128 patients with narcolepsy, two subjects had profound CNS depression, which resolved after supportive respiratory intervention. Two other patients discontinued sodium oxybate because of severe difficulty breathing and an increase in obstructive sleep apnea. In two controlled trials assessing polysomnographic (PSG) measures in patients with narcolepsy, 40 of 477 patients were included with a baseline apnea/hypopnea index of 16 to 67 events per hour, indicative of mild to severe sleep-disordered breathing. None of the 40 patients had a clinically significant worsening of respiratory function as measured by apnea/hypopnea index and pulse oximetry at doses of 4.5 g to 9 g per night.

Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients and in postmenopausal women not on hormone replacement therapy as well as among patients with narcolepsy.

Depression and Suicidality

In clinical trials in patients with narcolepsy (n=781), there were two suicides and two attempted suicides in Xyrem-treated patients, including three patients with a previous history of depressive psychiatric disorder. Of the two suicides, one patient used Xyrem in conjunction with other drugs. Xyrem was not involved in the second suicide. Adverse reactions of depression were reported by 7% of 781 Xyrem-treated patients, with four patients (< 1%) discontinuing because of depression. In most cases, no change in Xyrem treatment was required.

In a controlled trial, with patients randomized to fixed doses of 3 g, 6 g, or 9 g per night Xyrem or placebo, there was a single event of depression at the 3 g per night dose. In another controlled trial, with patients titrated from an initial 4.5 g per night starting dose, the incidences of depression were 1 (1.7%), 1 (1.5%), 2 (3.2%), and 2 (3.6%) for the placebo, 4.5 g, 6 g, and 9 g per night doses, respectively.

The emergence of depression in patients treated with Xyrem requires careful and immediate evaluation. Patients with a previous history of a depressive illness and/or suicide attempt should be monitored carefully for the emergence of depressive symptoms while taking Xyrem.

Other Behavioral or Psychiatic Adverse Reactions

During clinical trials in narcolepsy, 3% of 781 patients treated with Xyrem experienced confusion, with incidence generally increasing with dose.

Less than 1% of patients discontinued the drug because of confusion. Confusion was reported at all recommended doses from 6 g to 9 g per night. In a controlled trial where patients were randomized to fixed total daily doses of 3 g, 6 g, or 9 g per night or placebo, a dose-response relationship for confusion was demonstrated, with 17% of patients at 9 g per night experiencing confusion. In all cases in that controlled trial, the confusion resolved soon after termination of treatment. In Trial 3 where sodium oxybate was titrated from an initial 4.5 g per night dose, there was a single event of confusion in one patient at the 9 g per night dose. In the majority of cases in all clinical trials in narcolepsy, confusion resolved either soon after termination of dosing or with continued treatment. However, patients treated with Xyrem who become confused should be evaluated fully, and appropriate intervention considered on an individual basis.

Anxiety occurred in 5.8% of the 874 patients receiving Xyrem in clinical trials in another population. The emergence of or increase in anxiety in patients taking Xyrem should be carefully monitored.

Other neuropsychiatric reactions reported in Xyrem clinical trials included hallucinations, paranoia, psychosis, and agitation. The emergence of thought disorders and/or behavior abnormalities requires careful and immediate evaluation.

Parasomnias

Sleepwalking, defined as confused behavior occurring at night and at times associated with wandering, was reported in 6% of 781 patients with narcolepsy treated with Xyrem in controlled and long-term open-label studies, with < 1% of patients discontinuing due to sleepwalking. Rates of sleepwalking were similar for patients taking placebo and patients taking Xyrem in controlled trials. It is unclear if some or all of the reported sleepwalking episodes correspond to true somnambulism, which is a parasomnia occurring during non-REM sleep, or to any other specific medical disorder. Five instances of significant injury or potential injury were associated with sleepwalking during a clinical trial of Xyrem in patients with narcolepsy.

Parasomnias including sleepwalking have been reported in postmarketing experience with Xyrem. Therefore, episodes of sleepwalking should be fully evaluated and appropriate interventions considered.

Use in Patients Sensitive to High Sodium Intake

Xyrem has a high salt content. In patients sensitive to salt intake (e.g., those with heart failure, hypertension, or renal impairment) consider the amount of daily sodium intake in each dose of Xyrem. Table 2 provides the approximate sodium content per Xyrem dose.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sodium oxybate (patient information) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Sodium oxybate (patient information) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Sodium oxybate (patient information) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sodium oxybate (patient information) in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sodium oxybate (patient information) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sodium oxybate (patient information) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sodium oxybate (patient information) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sodium oxybate (patient information) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sodium oxybate (patient information) in geriatric settings.

Gender

There is no FDA guidance on the use of Sodium oxybate (patient information) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sodium oxybate (patient information) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sodium oxybate (patient information) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sodium oxybate (patient information) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sodium oxybate (patient information) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sodium oxybate (patient information) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Sodium oxybate (patient information) Administration in the drug label.

Monitoring

There is limited information regarding Sodium oxybate (patient information) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Sodium oxybate (patient information) and IV administrations.

Overdosage

There is limited information regarding Sodium oxybate (patient information) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Sodium oxybate (patient information) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Sodium oxybate (patient information) Mechanism of Action in the drug label.

Structure

There is limited information regarding Sodium oxybate (patient information) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Sodium oxybate (patient information) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Sodium oxybate (patient information) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Sodium oxybate (patient information) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Sodium oxybate (patient information) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Sodium oxybate (patient information) How Supplied in the drug label.

Storage

There is limited information regarding Sodium oxybate (patient information) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Sodium oxybate (patient information) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Sodium oxybate (patient information) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Sodium oxybate (patient information) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sodium oxybate (patient information) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

IMPORTANT WARNING:

Sodium oxybate is another name for GHB, a substance that is often illegally sold and abused, especially by young adults in social settings such as nightclubs. Sodium oxybate may be harmful when taken by people other than the person for whom it was prescribed. Do not sell or give your sodium oxybate to anyone else; selling or sharing it is against the law. Store sodium oxybate in a safe place, such as a locked cabinet or box, so that no one else can take it accidentally or on purpose. Keep track of how much liquid is left in your bottle so you will know if any is missing.

Take sodium oxybate exactly as directed. Do not take more of it or take it more often than prescribed by your doctor. If you take too much sodium oxybate, you may experience life-threatening symptoms including seizures, slowed or stopped breathing, loss of consciousness, and coma. You may also develop a craving for sodium oxybate, feel a need to take larger and larger doses, or want to continue taking sodium oxybate even though it causes unpleasant symptoms. If you have taken sodium oxybate in amounts larger than prescribed by your doctor, and you suddenly stop taking it, you may experience withdrawal symptoms such as difficulty falling asleep or staying asleep, restlessness, anxiety, abnormal thinking, loss of contact with reality, sleepiness, upset stomach, shaking of a part of your body that you cannot control, sweating, muscle cramps, and fast heartbeat.

Sodium oxybate may cause serious side effects even if it is taken as directed. Do not take antidepressants; medications for anxiety, mental illness, or seizures; sedatives; sleeping pills; or tranquilizers while you are taking sodium oxybate. Do not drink alcohol while you are taking sodium oxybate. Tell your doctor if you snore and if you have or have ever had lung disease, difficulty breathing, sleep apnea (a sleep disorder that causes breathing to stop for short periods during sleep), seizures, or depression. Also tell your doctor if you have ever thought about harming or killing yourself or planned or tried to do so, if you use or have ever used street drugs, or if you have overused prescription medications.If you experience any of the following symptoms, call your doctor immediately: depression, confusion, abnormal thoughts, thoughts of harming or killing yourself, anxiety, feeling that others want to harm you, hallucinations (seeing things or hearing voices that do not exist), loss of contact with reality, agitation, memory problems, breathing problems, snoring, sleep apnea, slowed or stopped breathing,or excessive drowsiness during the day.

Sodium oxybate is not available at retail pharmacies. A special program is in place to distribute the medication and provide information about the medication. You will receive written information and an instructional video about the safe use of sodium oxybate. Your medication will be mailed to you from a central pharmacy after you have read the information and talked to a pharmacist. Ask your doctor if you have any questions about how you will receive your medication.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with sodium oxybate and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/infopage/xyrem/medicationguide.htm.

Keep all appointments with your doctor. You should see your doctor at least every 3 months.

Talk to your doctor about the risks of taking sodium oxybate.

Why is this medication prescribed

Sodium oxybate is used to prevent attacks of cataplexy (episodes of muscle weakness that begin suddenly and last for a short time) in patients who have narcolepsy (a sleep disorder that may cause extreme sleepiness, sudden uncontrollable urge to sleep during daily activities, and cataplexy). Sodium oxybate is in a class of medications called central nervous system depressants. The way that sodium oxybate works to treat cataplexy is not known.

How should this medicine be used

Sodium oxybate comes as a solution (liquid) to mix with water and take by mouth. It is usually taken twice each night because sodium oxybate wears off after a short time and the effects of one dose will not last for the entire night. The first dose is taken at bedtime, and a second dose is taken 2 1/2 to 4 hours after the first dose. Sodium oxybate must be taken on an empty stomach, so the first dose should be taken several hours after the evening meal. Try to allow the same amount of time between your evening meal and your first dose of sodium oxybate every night. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Do not take your bedtime dose of sodium oxybate until you are in bed and are ready to go to sleep for the night. Sodium oxybate begins to work very quickly and you may have an upset stomach or feel dizzy or lightheaded if you take the medication before you go to bed for the night.

Place your second dose of sodium oxybate in a safe place near your bed before you go to sleep. Use an alarm clock to be sure that you will wake up in time to take the second dose. If you wake up before the alarm goes off and it has been at least 2 1/2 hours since you took your first dose, take your second dose, turn off the alarm, and go back to sleep.

Your doctor will probably start you on a low dose of sodium oxybate and gradually increase your dose, not more often than once every 2 weeks.

Sodium oxybate may help to control your symptoms but will not cure your condition. Continue to take sodium oxybate even if you feel well. Do not stop taking sodium oxybate without talking to your doctor. Your doctor will probably want to decrease your dose gradually. If you suddenly stop taking sodium oxybate, you may have more attacks of cataplexy and you may experience anxiety and difficulty falling asleep or staying asleep.

To prepare doses of sodium oxybate, follow these steps:

• Open the carton that your medicine came in and remove the bottle of medication and the measuring device.
• Remove the measuring device from its wrapper.
• Open the bottle by pushing down on the cap and turning the cap counterclockwise (to the left) at the same time.
• Place the open bottle upright on a table.
• Hold the bottle upright with one hand. Use your other hand to place the tip of the measuring device in the center opening on the top of the bottle. Press the tip firmly into the opening.
• Hold the bottle and measuring device with one hand. Use your other hand to pull back on the plunger until it is even with the marking that matches the dose your doctor prescribed. Be sure to keep the bottle upright to allow the medication to flow into the measuring device.
• Remove the measuring device from the top of the bottle. Place the tip of the measuring device in one of the dosing cups provided with the medication.
• Press down on the plunger to empty the medication into the dosing cup.
• Add 2 ounces (60 mL, 1/4 cup, or about 4 tablespoons) of tap water to the dosing cup. The medication will taste best if you mix it with cold water. Do not mix the medication with fruit juice, soft drinks, or any other liquid.
• Repeat steps 5-9 to prepare a dose of sodium oxybate in the second dosing cup.
• Place the caps on both dosing cups. Turn each cap clockwise (to the right) until it clicks and locks in place.
• Rinse the measuring device with water
• Replace the cap on the bottle of sodium oxybate and return the bottle and measuring device to the safe place where they are stored. Place both prepared dosing cups of medication in a safe place near your bed.
• When it is time for you to take the first dose of sodium oxybate, press down on the cap and turn it counterclockwise (to the left). Drink all of the liquid while you are sitting on your bed. Put the cap back on the cup, turn it clockwise (to the right) to lock it in place, and lie down right away.
• When you wake up 2 1/2 - 4 hours later to take the second dose, repeat step 14.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking sodium oxybate:

• tell your doctor and pharmacist if you are allergic to sodium oxybate or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention the medications listed in the IMPORTANT WARNING section and levodopa (Larodopa, in Sinemet). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are following a low salt diet for medical reasons and if you have or have ever had succinic semialdehyde dehydrogenase deficiency (an inherited condition in which certain substances build up in the body and cause retardation and developmental delays), heart failure, high blood pressure, or liver or kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking sodium oxybate, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking sodium oxybate.
• you should know that you will be very sleepy for at least 6 hours after you take sodium oxybate, and you may also be drowsy during the daytime. Do not drive a car, operate machinery, or perform any other dangerous activities for at least 6 hours after you take your medication. Avoid dangerous activities at all times until you know how sodium oxybate affects you.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

If you miss the first dose of sodium oxybate, you may take a dose when the second dose is scheduled; do not take a second dose of sodium oxybate that night. If you miss the second dose, skip the missed dose and continue your regular dosing schedule on the next night. Do not take a double dose to make up for a missed one. Always allow at least 2 1/2 hours between doses of sodium oxybate.

Side effects

Mild side effects

Sodium oxybate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bedwetting
• headache
• dizziness
• upset stomach
• vomiting
• diarrhea
• heartburn
• stomach pain
• back pain
• weakness
• difficulty falling asleep or staying asleep
• sweating
• flu-like symptoms
• ringing in the ears
• problems with vision
• painful or irregular menstrual periods
• abnormal sensitivity to touch or sound

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• sleepwalking
• abnormal dreams
• sore throat, fever, chills, and other signs of infection

Sodium oxybate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Throw away unused mixtures of sodium oxybate and water 24 hours after you prepare them. When you are ready to throw away a bottle of sodium oxybate, pour any remaining medication down the drain, use a marker to destroy the bottle label, and throw away the bottle with your household trash. Ask your doctor or call the central pharmacy if you have questions about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• confusion
• problems with coordination
• agitation
• loss of consciousness
• coma
• slow, shallow, or interrupted breathing
• loss of bladder control
• loss of bowel control
• vomiting
• sweating
• headache
• blurred vision
• muscle jerks or twitches
• seizure
• slow heartbeat
• low body temperature
• weak muscles

What other information should I know

Ask your doctor or call the central pharmacy if you have any questions about refilling your prescription.

Brand names

• Xyrem®

Other names

• Gamma Hydroxybutyrate Sodium
• GBH Sodium
• GHB Sodium
• γ-Hydroxybutyrate Sodium
• Oxybate Sodium