FDA

Sodium Oxybate

Approved 5 Nov 2025OralSolution

The FDA lists this product in 4 strengths and forms.

Indications

Sodium oxybate oral solution is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Sodium oxybate oral solutio n is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients with narcolepsy (1).

Contraindications

Sodium oxybate oral solution is contraindicated for use in: combination with sedative hypnotics [see Warnings and Precautions (5.1)]. combination with alcohol [see Warnings and Precautions (5.1)]. patients with succinic semialdehyde dehydrogenase deficiency [see Clinical Pharmacology (12.3)]. In combination with sedative hypnotics or alcohol ( 4 ) Succinic semialdehyde dehydrogenase deficiency ( 4 )

Warnings and precautions

CNS depression: Use caution when considering the concurrent use of sodium oxybate oral solution with other CNS depressants (5.1). Caution patients against hazardous activities requiring complete mental alertness or motor coordination within the first 6 hours of dosing or after first initiating treatment until certain that sodium oxybate oral solution does not affect them adversely (5.1). Depression and suicidality: Monitor patients for emergent or increased depression and suicidality (5.5).

Confusion/Anxiety: Monitor for impaired motor/cognitive function (5.6). Parasomnias: Evaluate episodes of sleepwalking (5.7). High sodium content in sodium oxybate oral solution: Monitor patients with heart failure, hypertension, or impaired renal function (5.8).

5.1Central Nervous System Depression

Sodium oxybate is a central nervous system (CNS) depressant. In adult clinical trials at recommended doses, obtundation and clinically significant respiratory depression occurred in patients treated with sodium oxybate oral solution. Sodium oxybate oral solution is contraindicated in combination with alcohol and sedative hypnotics. The concurrent use of sodium oxybate oral solution 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.

At a glance

Brand name: Sodium Oxybate
Route: Oral
Dosage form: Solution
Applicant: Ascent Pharms Inc
Status: Prescription
FDA approval: 5 Nov 2025
Application: ANDA210523-001

Indications

Contraindications

Warnings and precautions

5.1Central Nervous System Depression

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no adequate data on the developmental risk associated with the use of sodium oxybate in pregnant women. Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity; however, oral administration to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and growth, at a clinically relevant dose [see Data] .

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Labor or Delivery Sodium oxybate oral solution has not been studied in labor or delivery. In obstetric anesthesia using an injectable formulation of sodium oxybate, newborns had stable cardiovascular and respiratory measures but were very sleepy, causing a slight decrease in Apgar scores.

There was a fall in the rate of uterine contractions 20 minutes after injection. Placental transfer is rapid and gamma-hydroxybutyrate (GHB) has been detected in newborns at delivery after intravenous administration of GHB to mothers. Subsequent effects of sodium oxybate on later growth, development, and maturation in humans are unknown. Data Animal Data Oral administration of sodium oxybate to pregnant rats (150, 350, or 1,000 mg/kg/day) or rabbits (300, 600, or 1,200 mg/kg/day) throughout organogenesis produced no clear evidence of developmental toxicity.

The highest doses tested in rats and rabbits were approximately 1 and 3 times, respectively, the maximum recommended human dose (MRHD) of 9 g per night on a body surface area (mg/m 2 ) basis. Oral administration of sodium oxybate (150, 350, or 1,000 mg/kg/day) to rats throughout pregnancy and lactation resulted in increased stillbirths and decreased offspring postnatal viability and body weight gain at the highest dose tested.

The no-effect dose for pre- and postnatal developmental toxicity in rats is less than the MRHD on a mg/m 2 basis.

Adverse reactions

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).

To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc. at 1-866-495-8330, or FDA at 1-800-FDA-1088 or www.fda.gov/Medwatch.

6.1Clinical 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 Sodium oxybate oral solution 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 sodium oxybate oral solution, and 213 with placebo).

A total of 781 patients with narcolepsy were treated with sodium oxybate oral solution 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 sodium oxybate oral solution, 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 sodium oxybate oral solution 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 sodium oxybate oral solution 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 Sodium oxybate oral solution than Placebo in Three Controlled Trials (N1, N3, N4) by Body System and Dose at Onset Adverse Reaction Placebo (n=213) % Sodium oxybate oral solution 4.5g (n=185) % Sodium oxybate oral solution 6g (n=258) % Sodium oxybate oral solution 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 sodium oxybate oral solution. Pediatric use information is approved for Jazz Pharmaceuticals Inc.’s XYREM (sodium oxybate) Oral Solution. However, due to Jazz Pharmaceuticals Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of sodium oxybate oral solution. 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.

Sodium Oxybate

Indications

Contraindications

Warnings and precautions

5.1Central Nervous System Depression

At a glance

Two medicines in one question?

Sodium Oxybate

Indications

Contraindications

Warnings and precautions

5.1Central Nervous System Depression

At a glance

Two medicines in one question?

5.2Abuse and Misuse

5.3Sodium Oxybate REMS Program

5.4Respiratory Depression and Sleep-Disordered Breathing

5.5Depression and Suicidality

Interactions

7.1Alcohol, Sedative Hypnotics, and CNS Depressants

7.2Divalproex Sodium

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information