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Drug overview for LUMRYZ (sodium oxybate):
Generic name: sodium oxybate (SO-dee-um OX-eh-bait)
Drug class: Anti-Narcolepsy and Anti-Cataplexy Agents - Sedative-Type
Therapeutic class: Central Nervous System Agents
Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA; the drug is a CNS depressant that exhibits anticataplectic and potent hypnotic activity. Calcium, magnesium, potassium, and sodium oxybates is a preparation of sodium oxybate with a composition of cations resulting in a lower sodium content. Unless otherwise specified in this monograph, the term ''lower-sodium oxybate'' refers to the formulation containing calcium, magnesium, potassium and sodium oxybates (Xywav(R)).
No enhanced Uses information available for this drug.
Generic name: sodium oxybate (SO-dee-um OX-eh-bait)
Drug class: Anti-Narcolepsy and Anti-Cataplexy Agents - Sedative-Type
Therapeutic class: Central Nervous System Agents
Sodium oxybate is the sodium salt of gamma-hydroxybutyrate (GHB), an endogenous compound and metabolite of the neurotransmitter GABA; the drug is a CNS depressant that exhibits anticataplectic and potent hypnotic activity. Calcium, magnesium, potassium, and sodium oxybates is a preparation of sodium oxybate with a composition of cations resulting in a lower sodium content. Unless otherwise specified in this monograph, the term ''lower-sodium oxybate'' refers to the formulation containing calcium, magnesium, potassium and sodium oxybates (Xywav(R)).
No enhanced Uses information available for this drug.
DRUG IMAGES
No Image Available
The following indications for LUMRYZ (sodium oxybate) have been approved by the FDA:
Indications:
Cataplexy with associated narcolepsy
Narcolepsy syndrome
Professional Synonyms:
Friedmann's disease
Gelineau's syndrome
Hypnolepsy
Narcolepsy
Paroxysmal sleep
Indications:
Cataplexy with associated narcolepsy
Narcolepsy syndrome
Professional Synonyms:
Friedmann's disease
Gelineau's syndrome
Hypnolepsy
Narcolepsy
Paroxysmal sleep
The following dosing information is available for LUMRYZ (sodium oxybate):
When initiating divalproex sodium in patients taking a stable dosage of immediate-release sodium oxybate or lower-sodium oxybate, a reduction of the sodium oxybate dosage by at least 20% is recommended. When initiating immediate-release sodium oxybate or lower-sodium oxybate in patients already taking divalproex sodium, a lower starting dosage of sodium oxybate is recommended. Subsequently, adjust the dosage of sodium oxybate based on individual clinical response and tolerability.
The manufacturer of sodium oxybate extended-release suspension states that no dosage changes are recommended based on pharmacokinetic studies. However, a pharmacodynamic interaction between sodium oxybate and divalproex sodium, a sedative antiepileptic drug, cannot be ruled out.
The manufacturer of sodium oxybate extended-release suspension states that no dosage changes are recommended based on pharmacokinetic studies. However, a pharmacodynamic interaction between sodium oxybate and divalproex sodium, a sedative antiepileptic drug, cannot be ruled out.
Sodium oxybate is available as an immediate-release oral solution (Xyrem(R)) and extended-release granules for oral suspension (Lumryz(R)). Calcium, magnesium, potassium and sodium oxybates (lower-sodium oxybate) is available as an oral solution (Xywav(R)). Sodium oxybate oral solution (Xyrem(R)) should be stored at 25degreesC (excursions permitted between 15-30degreesC). Extended-release granules (Lumryz(R)) and lower-sodium oxybate oral solution (Xywav(R)) should be stored at 20-25degreesC (excursions permitted between 15-30degreesC).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LUMRYZ ER 4.5 GM PACKET | Maintenance | Adults take 1 packet (4.5 gram) by oral route once daily at bedtime |
| LUMRYZ ER 6 GM PACKET | Maintenance | Adults take 1 packet (6 gram) by oral route once daily at bedtime |
| LUMRYZ ER 7.5 GM PACKET | Maintenance | Adults take 1 packet (7.5 gram) by oral route once daily at bedtime |
| LUMRYZ ER 9 GM PACKET | Maintenance | Adults take 1 packet (9 gram) by oral route once daily at bedtime |
No generic dosing information available.
The following drug interaction information is available for LUMRYZ (sodium oxybate):
There are 1 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Oxybate/Sedative Hypnotics; Alcohol SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Oxybate may be associated with respiratory depression. As oxybate is taken at bedtime, concurrent use with alcohol or hypnotics may increase the risk for respiratory depression or loss of consciousness.(1-3) Primidone is metabolized to phenobarbital. CLINICAL EFFECTS: Concurrent use of sodium oxybate and sedative hypnotics or alcohol may further increase the risk for respiratory depression and profound sedation or coma.(1,2) Fatalities have been reported.(3) PREDISPOSING FACTORS: Based upon FDA evaluation of deaths in patients taking sodium oxybate, risk factors may include: use of multiple drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Note that in oxybate clinical trials for narcolepsy 78% - 85% of patients were also receiving concomitant CNS stimulants.(1-3) PATIENT MANAGEMENT: The FDA states that sodium oxybate is contraindicated in patients also taking hypnotics or alcohol.(1,2) Significant quantities of alcohol may be present in medicinal products. Alcohol is is used to improve docetaxel and paclitaxel solubility. - The quantity of alcohol in paclitaxel injection formulations (0.385-0.396 grams/mL) is similar across manufacturers. A paclitaxel 200 mg dose contains approximately 13 grams of alcohol. - The quantity of alcohol in docetaxel formulations varies approximately 3-fold depending upon the manufacturer. FDA data on alcohol content (4): Product Manufacturer Alcohol/200 mg dose Docetaxel Inj. Pfizer 6.4 grams Docetaxel Inj. Sandoz 5.5 grams Docetaxel Inj. Accord 4.0 grams Taxotere-one vial Sanofi 4.0 grams formulation Docetaxel Inj. Hospira 3.7 grams Docefrez Sun Pharma 2.9 grams Taxotere-two vial Sanofi 2.0 grams formulation DISCUSSION: The FDA evaluated sodium oxybate postmarket fatal adverse event reports from the FDA Adverse Event Reporting System(AERS)and from the manufacturer. Although report documentation was not always optimal or complete, useful information was obtained. Factors which may have contributed to fatal outcome: concomitant use of one or more drugs which depress the CNS, more rapid than recommended upward dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Many deaths occurred in patients with serious psychiatric disorders such as depression and substance abuse. Other concomitant diseases may have also contributed to respiratory and CNS depressant effects of oxybate.(3) |
AA 2%-D10W-CALCIUM, AA 2%-D10W-CALCIUM-HEPARIN, AA 2%-D10W-LOW CALCIUM-HEPARIN, AA 2%-D5W-CALCIUM-HEPARIN, AA 2.5%-D10W-CALCIUM-HEPARIN, AA 3%-D10W-CALCIUM, AA 3%-D10W-CALCIUM-HEPARIN, AA 3%-D10W-LOW CALCIUM-HEPARIN, AA 3%-D5W-CALCIUM, AA 3%-D5W-CALCIUM-HEPARIN, AA 3%-D5W-LOW CALCIUM-HEPARIN, AA 3.5%-D10W-CALCIUM, AA 3.5%-D10W-CALCIUM-HEPARIN, AA 3.5%-D10W-LO CALCIUM-HEPARN, AA 4%-D10W-CALCIUM-HEPARIN, AA 6%-D10W-CALCIUM-HEPARIN, ALCOHOL,DEHYDRATED, ALPRAZOLAM, ALPRAZOLAM ER, ALPRAZOLAM INTENSOL, ALPRAZOLAM ODT, ALPRAZOLAM XR, AMBIEN, AMBIEN CR, AMINO ACID 3%-D10W, AMINO ACID 3.5%-D10W, AMINO ACID 3.5%-D10W-HEPARIN, AMINO ACID 4%-D10W, AMINO ACID 4.5%-D10W-HEPARIN, AMINO ACIDS 2.5%-D10W, AMINOSYN II, AMINOSYN-PF, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, ATIVAN, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, BYFAVO, CHLORAL HYDRATE, CHLORDIAZEPOXIDE HCL, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CHLORDIAZEPOXIDE-CLIDINIUM, CLINIMIX, CLINIMIX E, CLINISOL, CLOBAZAM, CLONAZEPAM, CLORAZEPATE DIPOTASSIUM, DIAZEPAM, DICHLORALPHENAZONE, DONNATAL, DORAL, DOXEPIN HCL, EDLUAR, ESTAZOLAM, ESZOPICLONE, FIORICET, FIORICET WITH CODEINE, FLURAZEPAM HCL, HALCION, KABIVEN, KLONOPIN, LIBRAX, LORAZEPAM, LORAZEPAM INTENSOL, LOREEV XR, LUNESTA, MEPROBAMATE, MIDAZOLAM, MIDAZOLAM HCL, MIDAZOLAM HCL-0.8% NACL, MIDAZOLAM HCL-0.9% NACL, MIDAZOLAM HCL-D5W, MIDAZOLAM HCL-NACL, MIDAZOLAM-0.9% NACL, MIDAZOLAM-NACL, MKO (MIDAZOLAM-KETAMINE-ONDAN), MYSOLINE, NAYZILAM, ONFI, OXAZEPAM, PENTOBARBITAL SODIUM, PERIKABIVEN, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PLENAMINE, PREMASOL, PRIMIDONE, PROSOL, QUAZEPAM, RALDESY, RESTORIL, SEZABY, SILENOR, SODIUM BROMIDE, SYMPAZAN, TEMAZEPAM, TENCON, TRAVASOL, TRAZODONE HCL, TRIAZOLAM, VALIUM, VALTOCO, XANAX, XANAX XR, ZALEPLON, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE ER |
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Oxybate/Agents that May Cause Respiratory Depression SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Oxybate by itself may be associated with severe somnolence or respiratory depression. Concurrent use with other CNS depressants may further increase the risk for respiratory depression or loss of consciousness.(1-3) CLINICAL EFFECTS: Concurrent use of sodium oxybate and sedative hypnotics or alcohol may further increase the risk for profound sedation, respiratory depression, coma, and/or death.(1,2) Fatalities have been reported.(3) PREDISPOSING FACTORS: Based upon FDA evaluation of deaths in patients taking sodium oxybate, risk factors may include: use of multiple drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Note that in oxybate clinical trials for narcolepsy 78% - 85% of patients were also receiving concomitant CNS stimulants.(1-3) PATIENT MANAGEMENT: Avoid use of concomitant opioids, benzodiazepines, sedating antidepressants, sedating antipsychotics, general anesthetics, or muscle relaxants, particularly when predisposing risk factors are present. If combination use is required, dose reduction or discontinuation of one or more CNS depressants should be considered. If short term use of an opioid or general anesthetic is required, consider interruption of sodium oxybate treatment.(1,2) Respiratory depression can occur at any time during opioid therapy, especially during therapy initiation and following dosage increases. Consider this risk when using concurrently with other agents that may cause CNS depression.(4) Discuss naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). Consider prescribing naloxone to patients prescribed medicines to treat OUD or opioid analgesics (such as those taking CNS depressants) who are at increased risk of opioid overdose and when a patient has household members/close contacts at risk for accidental overdose.(5) DISCUSSION: The FDA evaluated sodium oxybate postmarket fatal adverse event reports from the FDA Adverse Event Reporting System(AERS)and from the manufacturer. Although report documentation was not always optimal or complete, useful information was obtained. Factors which may have contributed to fatal outcome: concomitant use of one or more drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Many deaths occurred in patients with serious psychiatric disorders such as depression and substance abuse. Other concomitant diseases may have also contributed to respiratory and CNS depressant effects of oxybate.(3) |
ACETAMIN-CAFF-DIHYDROCODEINE, AMIDATE, AMITRIPTYLINE HCL, AMOXAPINE, AMRIX, APADAZ, ASENAPINE MALEATE, BELBUCA, BELLADONNA-OPIUM, BENZHYDROCODONE-ACETAMINOPHEN, BREVITAL SODIUM, BRIXADI, BUPRENORPHINE, BUPRENORPHINE HCL, BUPRENORPHINE-NALOXONE, BUTORPHANOL TARTRATE, BUTRANS, CARISOPRODOL, CARISOPRODOL-ASPIRIN, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CHLORPROMAZINE HCL, CHLORZOXAZONE, CLOZAPINE, CLOZAPINE ODT, CLOZARIL, CYCLOBENZAPRINE HCL, CYCLOBENZAPRINE HCL ER, CYCLOPAK, CYCLOTENS, DEMEROL, DESFLURANE, DESIPRAMINE HCL, DIHYDROCODEINE BITARTRATE, DILAUDID, DIPRIVAN, DISKETS, DROPERIDOL, DSUVIA, DURAMORPH, ENDOCET, ETOMIDATE, FENTANYL, FENTANYL CITRATE, FENTANYL CITRATE-0.9% NACL, FENTANYL CITRATE-D5W, FENTANYL CITRATE-STERILE WATER, FENTANYL CITRATE-WATER, FENTANYL-BUPIVACAINE-0.9% NACL, FENTANYL-BUPIVACAINE-NACL, FENTANYL-ROPIVACAINE-0.9% NACL, FENTANYL-ROPIVACAINE-NACL, FEXMID, FORANE, GABAPENTIN, GABAPENTIN ER, GABARONE, GRALISE, HORIZANT, HYCODAN, HYDROCODONE BITARTRATE, HYDROCODONE BITARTRATE ER, HYDROCODONE-ACETAMINOPHEN, HYDROCODONE-CHLORPHENIRAMNE ER, HYDROCODONE-HOMATROPINE MBR, HYDROCODONE-IBUPROFEN, HYDROMET, HYDROMORPHONE ER, HYDROMORPHONE HCL, HYDROMORPHONE HCL-0.9% NACL, HYDROMORPHONE HCL-D5W, HYDROMORPHONE HCL-NACL, HYDROMORPHONE HCL-WATER, HYSINGLA ER, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, INFUMORPH, ISOFLURANE, KETALAR, KETAMINE HCL, KETAMINE HCL-0.9% NACL, KETAMINE HCL-NACL, KETAMINE HCL-WATER, LEVORPHANOL TARTRATE, LORZONE, LYBALVI, LYRICA, LYRICA CR, MEPERIDINE HCL, MEPERIDINE HCL-0.9% NACL, METAXALONE, METHADONE HCL, METHADONE HCL-0.9% NACL, METHADONE HCL-NACL, METHADONE INTENSOL, METHADOSE, METHOHEXITAL SODIUM, METHOHEXITAL-STERILE WATER, MIRTAZAPINE, MIRTAZAPINE ANHYDROUS, MITIGO, MORPHINE SULFATE, MORPHINE SULFATE ER, MORPHINE SULFATE-0.9% NACL, MORPHINE SULFATE-NACL, MS CONTIN, NALBUPHINE HCL, NALOCET, NEFAZODONE HCL, NEURONTIN, NORPRAMIN, NORTRIPTYLINE HCL, NUCYNTA, NUCYNTA ER, OLANZAPINE, OLANZAPINE ODT, OLANZAPINE-FLUOXETINE HCL, OLINVYK, OPIUM TINCTURE, OXYCODONE HCL, OXYCODONE HCL ER, OXYCODONE HYDROCHLORIDE, OXYCODONE-ACETAMINOPHEN, OXYCONTIN, OXYMORPHONE HCL, OXYMORPHONE HCL ER, PAMELOR, PENTAZOCINE-NALOXONE HCL, PERCOCET, PERPHENAZINE-AMITRIPTYLINE, PHENERGAN, PREGABALIN, PREGABALIN ER, PRIMLEV, PROLATE, PROMETHAZINE HCL, PROMETHAZINE HCL-0.9% NACL, PROMETHAZINE VC, PROMETHAZINE-DM, PROMETHAZINE-PHENYLEPHRINE HCL, PROMETHEGAN, PROPOFOL, PROTRIPTYLINE HCL, QUETIAPINE FUMARATE, QUETIAPINE FUMARATE ER, REMERON, REMIFENTANIL HCL, ROXICODONE, ROXYBOND, SAPHRIS, SECUADO, SEROQUEL, SEROQUEL XR, SEVOFLURANE, SOMA, SUBLOCADE, SUBOXONE, SUFENTANIL CITRATE, SUPRANE, TERRELL, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TREZIX, TRIFLUOPERAZINE HCL, TRIMIPRAMINE MALEATE, ULTANE, ULTIVA, VANADOM, VERSACLOZ, XTAMPZA ER, ZUBSOLV, ZYPREXA |
| Sodium Oxybate/Codeine; Tramadol SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Oxybate by itself may be associated with severe somnolence or respiratory depression. Concurrent use with other CNS depressants may further increase the risk for respiratory depression or loss of consciousness.(1-3) Codeine and tramadol are converted to their more active opioid metabolites (morphine and O-desmethyltramadol respectively) by CYP2D6. CLINICAL EFFECTS: Concurrent use of sodium oxybate and opioids such as tramadol, or alcohol may further increase the risk for respiratory depression and profound sedation, syncope or coma.(1,2) Fatalities have been reported.(3) PREDISPOSING FACTORS: Based upon FDA evaluation of deaths in patients taking sodium oxybate, risk factors may include: use of multiple drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. Note that in oxybate clinical trials for narcolepsy 78% - 85% of patients were also receiving concomitant CNS stimulants.(1-3) In patients receiving codeine or tramadol, ultrarapid metabolizers of CYP2D6 are more likely to have higher than normal systemic concentrations of the active opioid.(4) Other patients at high risk from this interaction include: adolescents between 12 and 18 years who are obese or have conditions such as obstructive sleep apnea or severe lung disease, which may increase the risk of respiratory depression; and breastfeeding women (due to the risk of serious adverse reactions in breastfed infants).(5) PATIENT MANAGEMENT: Avoid use of oxybate when concomitant opioids, benzodiazepines, sedating antidepressants, sedating antipsychotics, general anesthetics, or muscle relaxants, particularly when predisposing risk factors are present. If combination use is required, dose reduction or discontinuation of one or more CNS depressants should be considered. If short term use of an opioid or general anesthetic is required, consider interruption of sodium oxybate treatment.(1,2) Codeine and tramadol are converted to their active opioid metabolites by CYP2D6. Ultrarapid metabolizers of CYP2D6 more rapidly convert codeine or tramadol to their active metabolites (morphine and o-desmethyltramadol respectively) and so are more likely to have higher than normal systemic concentrations of the active opioid. Respiratory depression can occur at any time during opioid therapy, especially during therapy initiation and following dosage increases. Consider this risk when using concurrently with other agents that may cause CNS depression.(6) Discuss naloxone with all patients when prescribing or renewing an opioid analgesic or medicine to treat opioid use disorder (OUD). Consider prescribing naloxone to patients prescribed medicines to treat OUD or opioid analgesics (such as those taking CNS depressants) who are at increased risk of opioid overdose and when a patient has household members/close contacts at risk for accidental overdose.(7) DISCUSSION: The FDA evaluated sodium oxybate postmarket fatal adverse event reports from the FDA Adverse Event Reporting System(AERS) and from the manufacturer. Although report documentation was not always optimal or complete, useful information was obtained. Factors which may have contributed to fatal outcome: concomitant use of one or more drugs which depress the CNS, more rapid than recommended oxybate dose titration, exceeding the maximum recommended oxybate dose, and prescribing for unapproved uses such as fibromyalgia, insomnia or migraine. FDA reported the case of a 5-year-old patient who received one dose of tramadol following a tonsillectomy and experienced slow, difficult breathing requiring emergency intervention and hospitalization. The child was subsequently found to be an ultrarapid metabolizer of CYP2D6.(4) Many deaths occurred in patients with serious psychiatric disorders such as depression and substance abuse. Other concomitant diseases may have also contributed to respiratory and CNS depressant effects of oxybate.(3) |
ACETAMINOPHEN-CODEINE, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BUTALB-ACETAMINOPH-CAFF-CODEIN, CARISOPRODOL-ASPIRIN-CODEINE, CODEINE PHOSPHATE, CODEINE SULFATE, CONZIP, FIORICET WITH CODEINE, PROMETHAZINE-CODEINE, QDOLO, TRAMADOL HCL, TRAMADOL HCL ER, TRAMADOL HCL-ACETAMINOPHEN, TUXARIN ER |
There are 0 moderate interactions.
The following contraindication information is available for LUMRYZ (sodium oxybate):
Drug contraindication overview.
*Concomitant therapy with sedative-hypnotic agents or concomitant use with alcohol. *Succinic semialdehyde dehydrogenase (SSADH) deficiency.
*Concomitant therapy with sedative-hypnotic agents or concomitant use with alcohol. *Succinic semialdehyde dehydrogenase (SSADH) deficiency.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Alcohol intoxication |
| Alcohol use disorder |
| Succinate-semialdehyde dehydrogenase deficiency |
There are 10 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Child-pugh class A hepatic impairment |
| Child-pugh class B hepatic impairment |
| Child-pugh class C hepatic impairment |
| Depression |
| Disease of liver |
| Drug abuse |
| Respiratory depression |
| Seizure disorder |
| Sleep apnea |
| Suicidal ideation |
There are 5 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Acute cognitive impairment |
| Chronic heart failure |
| Hypertension |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Sleep walking disorder |
The following adverse reaction information is available for LUMRYZ (sodium oxybate):
Adverse reaction overview.
Adverse effects occurring in 5% or more of adult patients receiving sodium oxybate (Xyrem(R)) in controlled clinical trials and at least twice as frequently as with placebo include nausea, dizziness, vomiting, somnolence, enuresis, and tremor. Adverse effects occurring in 5% or more of adult patients receiving extended-release sodium oxybate (Lumryz(R)) in controlled clinical trials and at least twice as frequently as with placebo include nausea, dizziness, enuresis, headache, and vomiting. Adverse effects occurring in 5% or more of adult patients receiving lower-sodium oxybate (Xywav(R)) in controlled clinical trials for narcolepsy or idiopathic hypersomnia include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor. Adverse reactions occurring 5% or more of pediatric patients receiving immediate-release sodium oxybate (Xyrem(R)) include nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.
Adverse effects occurring in 5% or more of adult patients receiving sodium oxybate (Xyrem(R)) in controlled clinical trials and at least twice as frequently as with placebo include nausea, dizziness, vomiting, somnolence, enuresis, and tremor. Adverse effects occurring in 5% or more of adult patients receiving extended-release sodium oxybate (Lumryz(R)) in controlled clinical trials and at least twice as frequently as with placebo include nausea, dizziness, enuresis, headache, and vomiting. Adverse effects occurring in 5% or more of adult patients receiving lower-sodium oxybate (Xywav(R)) in controlled clinical trials for narcolepsy or idiopathic hypersomnia include nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor. Adverse reactions occurring 5% or more of pediatric patients receiving immediate-release sodium oxybate (Xyrem(R)) include nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking.
There are 18 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Depression Urinary incontinence |
Acute cognitive impairment CNS depression Dyspnea |
| Rare/Very Rare |
|---|
|
Accidental fall Angioedema Apnea Coma Drug-induced psychosis Hallucinations Hypersensitivity drug reaction Hypertension Infection Respiratory depression Seizure disorder Sleep apnea Suicidal ideation |
There are 48 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dizziness Drowsy Headache disorder Hyperhidrosis Insomnia Nausea Sleep walking disorder Symptoms of anxiety Tremor Vomiting |
Agitation Akathisia Anorexia Ataxia Constipation Diarrhea Disturbance of attention Dream disorder Dyspepsia Fatigue Muscle spasm Pain Parasomnia Paresthesia Upper abdominal pain Weight loss Xerostomia |
| Rare/Very Rare |
|---|
|
Aggressive behavior Altered consciousness Arthralgia Blurred vision Body fluid retention Hostility Hypoesthesia Irritability Loss of taste Memory impairment Nocturia Pain in extremities Panic disorder Paranoid disorder Pharyngitis Proteinuria Rhinitis Sedation hangover effect Sleep paralysis Stupor Viral infection |
The following precautions are available for LUMRYZ (sodium oxybate):
Safety and efficacy of sodium oxybate immediate-release oral solution (Xyrem(R)) have been established in pediatric patients 7 years of age and older for the management of narcolepsy in a double-blind, placebo-controlled, randomized-withdrawal study. In a study of pediatric patients with narcolepsy, serious adverse reactions included 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. Safety and efficacy of lower-sodium oxybate (Xywav(R)) for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older are supported by evidence from clinical studies of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of lower-sodium oxybate similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of lower-sodium oxybate from healthy adult volunteers.
Safety and efficacy of sodium oxybate extended-release suspension (Lumryz(R)) have been established in pediatric patients >=7 years of age for treatment of cataplexy or excessive daytime sleepiness. Sodium oxybate extended-release suspension has not been evaluated in a pediatric clinical trial; evidence supporting its use is from a double-blind, placebo-controlled, randomized-withdrawal study of immediate-release sodium oxybate. Safety and effectiveness of sodium oxybate and lower-sodium oxybate in pediatric patients younger than 7 years of age have not been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Safety and efficacy of sodium oxybate extended-release suspension (Lumryz(R)) have been established in pediatric patients >=7 years of age for treatment of cataplexy or excessive daytime sleepiness. Sodium oxybate extended-release suspension has not been evaluated in a pediatric clinical trial; evidence supporting its use is from a double-blind, placebo-controlled, randomized-withdrawal study of immediate-release sodium oxybate. Safety and effectiveness of sodium oxybate and lower-sodium oxybate in pediatric patients younger than 7 years of age have not been established.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data on the developmental risk associated with the use of sodium oxybate in pregnant women. Mixed evidence is available from animal studies; in pregnant rats and rabbits, administration 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. Sodium oxybate and lower-sodium oxybate have not been studied in labor or delivery; but use of an injectable formulation of sodium oxybate resulted in very sleepy newborns with a decrease in Apgar scores.
Insufficient information is available on the risk of sodium oxybate to a breastfed infant, and on milk production in nursing mothers. The metabolite, GHB, is excreted in human milk after oral administration of sodium oxybate. Caution is advised if the drug is administered in nursing women.
Clinical studies of sodium oxybate and lower-sodium oxybate in patients with narcolepsy or idiopathic hypersomnia did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults. In clinical trials of sodium oxybate in another patient population (i.e., patients with disorders other than narcolepsy), the incidence of headaches was higher in geriatric patients compared with younger adults. In general, dosage selection in geriatric patients should be cautious, usually starting at the lower end of the dosage range, because of the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy in these patients. Geriatric patients receiving sodium oxybate should be monitored for impaired motor or cognitive function.
The following prioritized warning is available for LUMRYZ (sodium oxybate):
WARNING: Sodium oxybate is a very powerful central nervous system (CNS) depressant with a high risk of abuse. It may cause slow/shallow breathing or severe drowsiness at recommended doses. It must be used only for the purpose that your doctor prescribes.
It is against the law to use this drug for any other purposes. Abuse or misuse of this drug can result in seizures, severe difficulty breathing, loss of consciousness, and even death. It must not be used with alcohol or other CNS depressants (see also Drug Interactions section).
To receive sodium oxybate in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
WARNING: Sodium oxybate is a very powerful central nervous system (CNS) depressant with a high risk of abuse. It may cause slow/shallow breathing or severe drowsiness at recommended doses. It must be used only for the purpose that your doctor prescribes.
It is against the law to use this drug for any other purposes. Abuse or misuse of this drug can result in seizures, severe difficulty breathing, loss of consciousness, and even death. It must not be used with alcohol or other CNS depressants (see also Drug Interactions section).
To receive sodium oxybate in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
The following icd codes are available for LUMRYZ (sodium oxybate)'s list of indications:
| Cataplexy with associated narcolepsy | |
| G47.411 | Narcolepsy with cataplexy |
| G47.421 | Narcolepsy in conditions classified elsewhere with cataplexy |
| Narcolepsy syndrome | |
| G47.4 | Narcolepsy and cataplexy |
| G47.41 | Narcolepsy |
| G47.411 | Narcolepsy with cataplexy |
| G47.419 | Narcolepsy without cataplexy |
| G47.42 | Narcolepsy in conditions classified elsewhere |
| G47.421 | Narcolepsy in conditions classified elsewhere with cataplexy |
| G47.429 | Narcolepsy in conditions classified elsewhere without cataplexy |
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