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Xyrem

Last reviewed on RxList: 11/8/2018
Xyrem Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/8/2018

Xyrem (sodium oxybate) is a central nervous system depressant drug indicated for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy. Side effects of Xyrem include:

  • dizziness,
  • nausea,
  • vomiting,
  • diarrhea, or
  • shallow breathing.

Tell your doctor if you have serious side effects of Xyrem including:

The recommended starting dose of Xyrem is 4.5 grams per night administered orally in two equal, divided doses: 2.25 g at bedtime and 2.25 g taken 2.5 to 4 hours later. Xyrem may interact with alcohol or other drugs used for sleep or sedation, including cold medicines, narcotics, muscle relaxers, or medicines for anxiety, depression, or seizures. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Xyrem. Xyrem is not expected to harm a fetus. It is unknown if Xyrem passes into breast milk. Consult your doctor before breastfeeding.

Our Xyrem (sodium oxybate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Xyrem Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using sodium oxybate and call your doctor at once if you have:

  • weak or shallow breathing, breathing that stops for short periods of time;
  • aggression, paranoia, hallucinations (seeing or hearing things);
  • sleepwalking, waking and confused behavior at night;
  • depression, agitation, unusual or unpleasant thoughts; or
  • suicidal thoughts or actions.

Common side effects may include:

  • drowsiness, dizziness;
  • bed-wetting;
  • nausea, vomiting; or
  • tremors.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xyrem (Sodium Oxybate)

Xyrem Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions appear in other sections of the labeling:

  • CNS depression [see WARNINGS AND PRECAUTIONS]
  • Abuse and Misuse [see WARNINGS AND PRECAUTIONS]
  • Respiratory Depression and Sleep-Disordered Breathing [see WARNINGS AND PRECAUTIONS]
  • Depression and Suicidality [see WARNINGS AND PRECAUTIONS]
  • Other Behavioral or Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Parasomnias [see WARNINGS AND PRECAUTIONS]
  • Use in Patients Sensitive to High Sodium Intake [see WARNINGS AND PRECAUTIONS]

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 below 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

System Organ Class/Adverse Reaction Placebo
(n=213) %
Xyrem 4.5 g
(n=185) %
Xyrem 6 g
(n=258) %
Xyrem 9 g
(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
Pain in extremity 1 3 1 1
Cataplexy 1 1 1 2
Muscle spasms 2 2 <1 2
NERVOUS SYSTEM DISORDERS
Dizziness 4 9 11 15
Somnolence 4 1 3 8
Tremor 0 0 2 5
Paresthesia 1 2 1 3
Disturbance in attention 0 1 0 4
Sleep paralysis 1 0 1 3
PSYCHIATRIC DISORDERS
Disorientation 1 1 2 3
Anxiety 1 1 1 2
Irritability 1 0 <1 3
Sleep walking 0 0 0 3
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 up to 377 days (median exposure 332 days).

Adverse Reactions Leading To Treatment Discontinuation

In the pediatric clinical trial, 5 of 104 patients reported adverse reactions that led to withdrawal from the study (hallucination, tactile; suicidal ideation; weight decreased; sleep apnea syndrome; and affect lability).

Adverse Reactions In The Pediatric Clinical Trial

The most common adverse reactions (>5%) were enuresis (18%), nausea (17%), headache (16%), vomiting (16%), weight decreased (12%), decreased appetite (8%), and dizziness (6%).

Additional information regarding safety in pediatric patients appears in the following sections:

  • Respiratory Depression and Sleep-Disordered Breathing [see WARNINGS AND PRECAUTIONS]
  • Depression and Suicidality [see WARNINGS AND PRECAUTIONS]
  • Other Behavioral or Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Parasomnias [see WARNINGS AND PRECAUTIONS]

The overall adverse reaction profile of Xyrem in the pediatric clinical trial was similar to that seen in the adult clinical trial program.

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.

Read the entire FDA prescribing information for Xyrem (Sodium Oxybate)

Related Resources for Xyrem

Read the Xyrem User Reviews »

© Xyrem Patient Information is supplied by Cerner Multum, Inc. and Xyrem Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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