Xyrem

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Dosage for Adult Patients
• Initiate dosage at 4.5 g per night orally, divided into two doses ( 2.1 ).
• Titrate to effect in increments of 1.5 g per night at weekly intervals (0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later) ( 2.1 ).
• Recommended dosage range:
• 6 g to 9 g per night orally ( 2.1 ). Total Nightly Dose Take at Bedtime
• Take 2.5 to 4 Hours Later 4.5 g per night 2.25 g 2.25 g 6 g per night 3 g 3 g 7.5 g per night 3.75 g 3.75 g 9 g per night 4.5 g 4.5 g Dosage for Pediatric Patients (7 years of Age and Older)
• The recommended starting dosage, titration regimen, and maximum total nightly dosage are based on body weight (2.2 ). Important Administration Information
• Prepare both doses prior to bedtime; dilute each dose with approximately ¼ cup of water in pharmacy-provided containers ( 2.3 ).
• Allow 2 hours after eating before dosing ( 2.3 ).
• Take each dose while in bed and lie down after dosing ( 2.3 ). Patients with Hepatic Impairment Recommended starting dosage is one-half of the original dosage per night administered orally, divided into two doses ( 2.4 ). 2.1 Adult Dosing Information The recommended starting dosage is 4.5 grams (g) per night administered orally, divided into two doses:
• 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later (see Table 1). Increase the dosage by 1.5 g per night at weekly intervals (additional 0.75 g at bedtime and 0.75 g taken 2.5 to 4 hours later) to the effective dosage range of 6 g to 9 g per night orally. The dosage may be gradually titrated based on efficacy and tolerability. Doses higher than 9 g per night have not been studied and should not ordinarily be administered. Table 1:
• Recommended Adult Xyrem Dose Regimen (g = grams) If a Patient’s Total Nightly Dose is:
• Take at Bedtime:
• Take 2.5 to 4 Hours Later:
• 4.5 g per night 2.25 g 2.25 g 6 g per night 3 g 3 g 7.5 g per night 3.75 g 3.75 g 9 g per night 4.5 g 4.5 g 2.2 Pediatric Dosing Information Xyrem is administered orally twice nightly. The recommended starting pediatric dosage, titration regimen, and maximum total nightly dosage are based on patient weight, as specified in Table 2. The dosage may be gradually titrated based on efficacy and tolerability. Table 2:
• Recommended Pediatric Xyrem Dosage for Patients 7 Years of Age and Older* Patient Weight Initial Dosage Maximum Weekly Dosage Increase Maximum Recommended Dosage Take at Bedtime:
• Take 2.5 to 4 Hours Later:
• Take at Bedtime:
• Take 2.5 to 4 Hours Later:
• Take at Bedtime:
• Take 2.5 to 4 Hours Later:
• <20 kg** There is insufficient information to provide specific dosing recommendations for patients who weigh less than 20 kg. 20 kg to <30 kg ≤1 g ≤1 g 0.5 g 0.5 g 3 g 3 g 30 kg to <45 kg ≤1.5 g ≤1.5 g 0.5 g 0.5 g 3.75 g 3.75 g ≥45 kg ≤2.25 g ≤2.25 g 0.75 g 0.75 g 4.5 g 4.5 g * For patients who sleep more than 8 hours per night, the first dose of Xyrem may be given at bedtime or after an initial period of sleep. ** If Xyrem is used in patients 7 years of age and older who weigh less than 20 kg, a lower starting dosage, lower maximum weekly dosage increases, and lower total maximum nightly dosage should be considered. Note:
• Some patients may achieve better responses with unequal doses at bedtime and 2.5 to 4 hours later. 2.3 Important Administration Instructions for All Patients The total nightly dosage of Xyrem is divided into two doses. Prepare both doses of Xyrem prior to bedtime. Prior to ingestion, each dose of Xyrem should be diluted with approximately ¼ cup (approximately 60 mL) of water in the empty pharmacy containers provided. Take the first nightly dose of Xyrem at least 2 hours after eating [see Clinical Pharmacology ( 12.3 )] . Take the second nightly dose 2.5 to 4 hours after the first dose. Patients should take both doses of Xyrem while in bed and lie down immediately after dosing, and remain in bed following ingestion of each dose. Xyrem may cause patients to fall asleep abruptly without first feeling drowsy [see Adverse Reactions ( 6.2 )] . Patients will often fall asleep within 5 minutes of taking Xyrem, and will usually fall asleep within 15 minutes, though the time it takes any individual patient to fall asleep may vary from night to night. Patients may need to set an alarm to awaken for the second dose. Rarely, patients may take up to 2 hours to fall asleep. If the second dose is missed, that dose should be skipped and Xyrem should not be taken again until the next night. Both Xyrem doses should never be taken at one time. 2.4 Dosage Modification in Patients with Hepatic Impairment The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally divided into two doses [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )] . 2.5 Dosage Adjustment with Co-administration of Divalproex Sodium When initiating divalproex sodium in patients taking a stable dosage of Xyrem, a reduction of the Xyrem dosage by at least 20% is recommended with initial concomitant use [see Drug Interactions ( 7.2 ) and Clinical Pharmacology ( 12.3 )] . When initiating Xyrem in patients already taking divalproex sodium, a lower starting dosage of Xyrem is recommended. Subsequently, the dosage of Xyrem can be adjusted based on individual clinical response and tolerability.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• The safety and effectiveness of Xyrem in the treatment of cataplexy or excessive daytime sleepiness in pediatric patients (7 years of age and older) with narcolepsy have been established in a double-blind, placebo-controlled, randomized-withdrawal study [see Adverse Reactions ( 6.1 ) and Clinical Studies ( 14.3 )] .
• In the pediatric clinical trial with Xyrem administration in patients with narcolepsy, serious adverse reactions of central sleep apnea and oxygen desaturation documented by polysomnography evaluation; depression; suicidal ideation; neuropsychiatric reactions including acute psychosis, confusion, and anxiety; and parasomnias, including sleepwalking, have been reported [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 , 5.7 ) and Adverse Reactions ( 6.1 )] .
• Safety and effectiveness of Xyrem in pediatric patients below the age of 7 years have not been established.
• Juvenile Animal Toxicity Data In a study in which sodium oxybate (0, 100, 300, or 900 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days 21 through 90), mortality was observed at the two highest doses tested.
• Deaths occurred during the first week of dosing and were associated with clinical signs (including decreased activity and respiratory rate) consistent with the pharmacological effects of the drug.
• Reduced body weight gain in males and females and delayed sexual maturation in males were observed at the highest dose tested.
• The no-effect dose for adverse effects in juvenile rats is associated with plasma exposures (AUC) less than that at the maximum recommended human dose (9 g/night).

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of Xyrem in patients with narcolepsy did not include sufficient numbers of subjects age 65 years and older to determine whether they respond differently from younger subjects.
• In controlled trials in another population, 39 (5%) of 874 patients were 65 years or older.
• Discontinuations of treatment due to adverse reactions were increased in the elderly compared to younger
• adults (21% vs. 19%).
• Frequency of headaches was markedly increased in the elderly (39% vs. 19%).
• The most common adverse reactions were similar in both age categories.
• In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following clinically significant adverse reactions appear in other sections of the labeling:
• CNS depression [see Warnings and Precautions ( 5.1 )]
• Abuse and Misuse [see Warnings and Precautions ( 5.2 )]
• Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions ( 5.4 )]
• Depression and Suicidality [see Warnings and Precautions ( 5.5 )]
• Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )]
• Parasomnias [see Warnings and Precautions ( 5.7 )]
• Use in Patients Sensitive to High Sodium Intake [see Warnings and Precautions ( 5.8 )] Most common adverse reactions in
• adults (≥5% and at least twice the incidence with placebo) were nausea, dizziness, vomiting, somnolence, enuresis, and tremor ( 6.1 ). Most common adverse reactions in pediatric patients (≥5%) were nausea, enuresis, vomiting, headache, weight decreased, decreased appetite, dizziness, and sleepwalking ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Jazz Pharmaceuticals, Inc. at 1-800-520-5568, or FDA at 1-800-FDA-1088 or www.fda.gov/Medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adult Patients Xyrem was studied in three placebo-controlled clinical trials (Trials N1, N3, and N4, described in Sections 14.1 and 14.2 ) in 611 patients with narcolepsy (398 subjects treated with Xyrem, and 213 with placebo). A total of 781 patients with narcolepsy were treated with Xyrem in controlled and uncontrolled clinical trials. Section 6.1 and Table 4 present adverse reactions from three pooled, controlled trials (N1, N3, N4) in patients with narcolepsy. Adverse Reactions Leading to Treatment Discontinuation:
• Of the 398 patients with narcolepsy treated with Xyrem, 10.3% of patients discontinued because of adverse reactions compared with 2.8% of patients receiving placebo. The most common adverse reaction leading to discontinuation was nausea (2.8%). The majority of adverse reactions leading to discontinuation began during the first few weeks of treatment. Commonly Observed Adverse Reactions in Controlled Clinical Trials:
• The most common adverse reactions (incidence ≥5% and twice the rate seen with placebo) in patients treated with Xyrem were nausea, dizziness, vomiting, somnolence, enuresis, and tremor. Adverse Reactions Occurring at an Incidence of 2% or Greater:
• Table 4 lists adverse reactions that occurred at a frequency of 2% or more in any treatment group for three controlled trials and were more frequent in any Xyrem treatment group than with placebo. Adverse reactions are summarized by dose at onset. Nearly all patients in these studies initiated treatment at 4.5 g per night. In patients who remained on treatment, adverse reactions tended to occur early and to diminish over time. Table 4 Adverse Reactions Occurring in ≥2% of Adult Patients and More Frequently with Xyrem than Placebo in Three Controlled Trials (N1, N3, N4) by Body System and Dose at Onset Adverse Reaction Placebo (n=213) % Xyrem 4.5g (n=185) % Xyrem 6g (n=258) % Xyrem 9g (n=178) % ANY ADVERSE REACTION 62 45 55 70 GASTROINTESTINAL DISORDERS Nausea 3 8 13 20 Vomiting 1 2 4 11 Diarrhea 2 4 3 4 Abdominal pain upper 2 3 1 2 Dry mouth 2 1 2 1 GENERAL DISORDERS AND ADMINISTRATIVE SITE CONDITIONS Pain 1 1 <1 3 Feeling drunk 1 0 <1 3 Edema peripheral 1 3 0 0 MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Cataplexy 1 1 1 2 Muscle spasms 2 2 <1 2 Pain in extremity 1 3 1 1 NERVOUS SYSTEM DISORDERS Dizziness 4 9 11 15 Somnolence 4 1 3 8 Tremor 0 0 2 5 Disturbance in attention 0 1 0 4 Paresthesia 1 2 1 3 Sleep paralysis 1 0 1 3 PSYCHIATRIC DISORDERS Disorientation 1 1 2 3 Irritability 1 0 <1 3 Sleepwalking 0 0 0 3 Anxiety 1 1 1 2 RENAL AND URINARY DISORDERS Enuresis 1 3 3 7 SKIN AND SUBCUTANEOUS TISSUE DISORDERS Hyperhidrosis 0 1 1 3 Dose-Response Information In clinical trials in narcolepsy, a dose-response relationship was observed for nausea, vomiting, paresthesia, disorientation, irritability, disturbance in attention, feeling drunk, sleepwalking, and enuresis. The incidence of all these reactions was notably higher at 9 g per night. In controlled trials in narcolepsy, discontinuations of treatment due to adverse reactions were greater at higher doses of Xyrem. Pediatric Patients (7 Years of Age and Older) In the pediatric clinical trial (Trial N5), 104 patients aged 7 to 17 years (37 patients aged 7 to 11 years; 67 patients aged 12 to 17 years) with narcolepsy received Xyrem for up to one year. This study included an open-label safety continuation period in which eligible patients received Xyrem for up to an additional 2 years. The median and maximum exposure across the entire study were 371 and 987 days, respectively. Adverse Reactions Leading to Treatment Discontinuation In the pediatric clinical trial, 7 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; affect lability; anger, anxiety, depression; and headache). Adverse Reactions in the Pediatric Clinical Trial The most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). Additional information regarding safety in pediatric patients appears in the following sections:
• Respiratory Depression and Sleep-Disordered Breathing [see Warnings and Precautions ( 5.4 )]
• Depression and Suicidality [see Warnings and Precautions ( 5.5 )]
• Other Behavioral or Psychiatric Adverse Reactions [see Warnings and Precautions ( 5.6 )]
• Parasomnias [see Warnings and Precautions ( 5.7 )] The overall adverse reaction profile of Xyrem in the pediatric clinical trial was similar to that seen in the adult clinical trial program. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Xyrem. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
• arthralgia, decreased appetite, fall*, fluid retention, hangover, headache, hypersensitivity, hypertension, memory impairment, nocturia, panic attack, vision blurred, and weight decreased. * The sudden onset of sleep in patients taking sodium oxybate, including in a standing position or while rising from bed, has led to falls complicated by injuries, in some cases requiring hospitalization.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Central Nervous System Depression Inform patients and/or caregivers that Xyrem can cause central nervous system depression, including respiratory depression, hypotension, profound sedation, syncope, and death. Instruct patients to not engage in activities requiring mental alertness or motor coordination, including operating hazardous machinery, for at least 6 hours after taking Xyrem. Instruct patients and/or their caregivers to inform their healthcare providers of all the medications they take [see Warnings and Precautions ( 5.1 )]. Abuse and Misuse Inform patients and/or caregivers that the active ingredient of Xyrem is gamma-hydroxybutyrate (GHB), which is associated with serious adverse reactions with illicit use and abuse [see Warnings and Precautions ( 5.2 )]. XYWAV and XYREM REMS Xyrem is available only through a restricted program called the XYWAV and XYREM REMS [see Warnings and Precautions ( 5.3 )]. Inform the patient and/or caregiver of the following notable requirements:
• Xyrem is dispensed only by the central pharmacy
• Xyrem will be dispensed and shipped only to patients enrolled in the XYWAV and XYREM REMS Xyrem is available only from the central pharmacy participating in the program. Therefore, provide patients and/or caregivers with the telephone number and website for information on how to obtain the product. Alcohol or Sedative Hypnotics Advise patients and/or caregivers that alcohol and other sedative hypnotics should not be taken with Xyrem [see Contraindications ( 4 )] . Sedation Inform patients and/or caregivers that the patient is likely to fall asleep quickly after taking Xyrem (often within 5 and usually within 15 minutes), but the time it takes to fall asleep can vary from night to night. The sudden onset of sleep, including in a standing position or while rising from bed, has led to falls complicated by injuries, in some cases requiring hospitalization [see Adverse Reactions ( 6.2 )] . Instruct patients and/or caregivers that the patient should remain in bed following ingestion of the first and second nightly doses. Instruct patients and/or caregivers that the patient should not take their second nightly dose until 2.5 to 4 hours after the first dose [see Dosage and Administration ( 2.3 )] . Food Effects on Xyrem Inform patients and/or caregivers that the first nightly dose should be taken at least 2 hours after eating. Respiratory Depression and Sleep-Disordered Breathing Inform patients that Xyrem may impair respiratory drive, especially in patients with compromised respiratory function, and may cause apnea [see Warnings and Precautions ( 5.4 )] . Depression and Suicidality Instruct patients and/or caregivers to contact a healthcare provider immediately if the patient develops depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, or suicidal ideation [see Warnings and Precautions ( 5.5 )] . Other Behavioral or Psychiatric Adverse Reactions Inform patients and/or caregivers that Xyrem can cause behavioral or psychiatric adverse reactions, including confusion, anxiety, and psychosis. Instruct them to notify their healthcare provider if any of these types of symptoms occur [see Warnings and Precautions ( 5.6 )]. Sleepwalking Instruct patients and/or caregivers that Xyrem has been associated with sleepwalking and other behaviors during sleep, and to contact their healthcare provider if this occurs [see Warnings and Precautions ( 5.7 )] . Sodium Intake Instruct patients and/or caregivers that Xyrem contains a significant amount of sodium and patients who are sensitive to sodium intake (e.g., those with heart failure, hypertension, or renal impairment) should limit their sodium intake [see Warnings and Precautions ( 5.8 )] . Distributed By:
• Jazz Pharmaceuticals, Inc. Palo Alto, CA 94306 Protected by U.S. Patent Nos. 8,772,306; 9,050,302; 9,486,426; 10,213,400; 10,864,181; and 11,253,494.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS Xyrem is a clear to slightly opalescent oral solution, in a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate). Oral solution, 0.5 g per mL ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 16.1 How Supplied Xyrem is a clear to slightly opalescent oral solution.
• Each prescription includes one bottle of Xyrem with attached press in bottle adaptor, an oral measuring device (plastic syringe), and a Medication Guide.
• The pharmacy provides two empty containers with child-resistant caps with each Xyrem shipment.
• Each amber bottle contains Xyrem oral solution at a concentration of 0.5 g per mL (0.5 g/mL of sodium oxybate equivalent to 0.413 g/mL of oxybate) and has a child-resistant cap.
• One 180 mL bottle NDC 68727-100-01
• 16.2 Storage Keep out of reach of children.
• Xyrem should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).
• Dispense in tight containers.
• Solutions prepared following dilution should be consumed within 24 hours.
• 16.3 Handling and Disposal Xyrem is a Schedule III drug under the Controlled Substances Act.
• Xyrem should be handled according to state and federal regulations.
• It is safe to dispose of Xyrem down the sanitary sewer.

Quoted from the official label, section “How Supplied”.

What is in it

• Sodium oxybate, a CNS depressant, is the active ingredient in Xyrem.
• The chemical name for sodium oxybate is sodium 4-hydroxybutyrate.
• The molecular formula is C 4 H 7 NaO 3 , and the molecular weight is 126.09 g/mole.
• The chemical structure is:
• Sodium oxybate is a white to off-white, crystalline powder that is very soluble in aqueous solutions.
• Each mL of Xyrem contains 0.5 g of sodium oxybate (equivalent to 0.413 g/mL of oxybate) in USP Purified Water, neutralized to pH 7.5 with malic acid. chemical structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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