Xywav

What is Xywav?

Xywav can be used to combat cataplexy (sudden loss of muscle strength) or to lessen excessive sleepiness during the day caused by the condition known as narcolepsy. It is also prescribed to the adult population to help treat idiopathic hypersomnia (IH), which is a rare chronic sleep disorder that causes excessive daytime sleepiness, even after a great night's rest.Xywav is a central nervous system depressant. It is an oral solution that consists of potassium oxybate, calcium oxybate, magnesium oxybate, and sodium oxybate. It is a low-sodium alternative to Xyrem.The ingredient in Xywav is known as GHB, which is a well-known street drug. Due to the potential for abuse and severe adverse effects, Xywav can be available only through a certified pharmacy in a programme specifically designed for it (XYREM MS). You must be enrolled in the programme and fully understand the dangers and advantages of this drug.

Xywav is FDA-approved for treating:

• Treatment for cataplexy or excess daytime sleepiness (EDS) for patients aged 7 and over with narcolepsy.
• Treatment of idiopathic sleepiness (IH) in adults

Absolutely. Xywav is classified as a Schedule III controlled substance (CIII) when it is used in a legal manner. It is regarded as a Schedule I controlled substance when it is used illegally and at risk of Schedule I penalties. The active ingredient in Xywav is a variant of gammahydroxybutyrate (GHB). Utilising illegal GHB in combination with other CNS depressants could cause serious health problems.

Warnings

Xywav may cause severe sleepiness and could cause breathing to slow or cease even in normal doses, or if you're taking stimulant medications. Do not engage in any activity that requires you to be awake or that could be dangerous, such as driving a vehicle, using machinery that is heavy, or flying in an aeroplane for a minimum of 6 hours following having taken Xywav. These activities shouldn't be completed until you have a clear understanding of the extent to which Xywav can affect either you or the children in your care.The risk of fatal side effects is high when you use Xywav together with alcohol, other sleep medicines, or other substances that cause drowsiness or slow breathing.The misuse of Xywav could cause breathing issues, seizures, loss of consciousness, or even death. Place the medication in a safe place so that others can't access it.Xywav could be a habit-forming drug. Intoxication can lead to an overdose or even death. Make sure the medication is stored in a location where other people aren't able to access it.

Similar or related drugs

Xyrem, Lumryz, Adderall, methylphenidate, Ritalin, Concerta, and Modafinil

Before you take this drug

Avoid drinking alcohol or using other sleep medications in conjunction with Xywav. Risky side effects or even death may occur.Don't provide Xywav to anyone suffering from the rare disorder known as succinic semialdehyde-dehydrogenase deficiency (which could cause physical or mental impairment).

To ensure you can safely take Xywav, inform your doctor if you previously had:

• Breathing issues;
• Snoring as well as the sleep disorder known as sleep apnea (breathing ceases when you sleep);
• Suicidal or depression-related thoughts;
• Psychosis, or abnormal behaviour (anxiety, agitation, and paranoid hallucinations);
• Liver disease liver disease
• Addiction to drugs.

Not permitted for use by people less than 7 years old who suffer from narcolepsy. It is not recommended for use by anyone less than 18 suffering from the condition known as idiopathic hypersomnia.

Pregnancy

Inform your doctor if you are expecting or planning to be pregnant. It isn't known whether Xywav could cause harm to your baby.

Breastfeeding

Inform your doctor if you intend to or are currently breastfeeding. breastfeed. Xywav is absorbed into the milk of your baby. Your doctor and you should decide if your child should take Xywav in addition to breastfeeding.

How to take Xywav?

You should take Xywav exactly as directed by your physician. Follow the directions on the prescription label and go through the entire medication guide or instruction sheet. Xywav can cause extreme drowsiness and could slow or stop your breathing, even in regular doses, or if you're also taking a stimulant medication.Xywav could be a trigger for an addiction. Misuse can cause addiction or overdose. It can also cause death. Put the medication in a place where users are unable to access the medicine. The selling or distribution of this medication is against the law. Don't allow anyone else to take this medication.Xywav instructions Take a minimum of 2 hours after eating before making and/or giving Xywav.Xywav can be taken as a single every night or in two doses (once at bedtime and another 2.5 up to four hours after).Mix Xywav with two ounces (1/4 cup) of water within the dosing cups for children that come with the medicine.

If you are taking two nightly doses, make each dose while getting ready to go to bed. Put the second dose in a safe place near your bed in order to be able to take it in the same place without waking up. You might have to set an alarm that will wake you up to take your second dosage.This drug works fast. Most people fall asleep in 5 to 15 minutes.Take Xywav only when you are asleep in bed, ready to go to sleep. There have been instances of people falling asleep in the process of standing or stepping out of bed and suffering injuries that are severe enough to require hospital treatment.Do not permit your child to take this medication without supervision from an adult.Don't alter the dose or stop taking Xywav abruptly, or you may experience painful withdrawal signs. Discuss with your doctor the best way to stop taking this medicine in a safe manner.Store the item in an airy and dry area, far away from humidity and heat. Place your medication in a safe place, in a place where nobody will use it in a way that isn't safe.Discard any dose not consumed within 24 hours of mixing.Don't keep anything left over from Xywav liquid. Consult your pharmacist on how you can find a drug disposal programme that takes back the drug. If there isn't a take-back programme available, simply pour any liquid medicine that is not used into the sink drain.

Details on dosage

Usual Adult Dose of Xywav for Narcolepsy

Dose initial: 4.5 mg orally daily, divided into 2 equal doses, up to 2.25 grams per dose.

Dose for maintenance: It is possible to increase the dose by 1.5 grammes (OR 0.75 grammes/dose) at night or orally during weekly intervals of 6–9 g/day.

Maximum dose: 9 g/day

Comments:

• Both doses should be taken simultaneously in the evening.
• The first dose should be taken prior to bed, while the second dose is to be taken between 2.5 and 4 hours following the first dose. Some may have to set alarms to get up to take the second dose.
• Patients should stay in bed following every dose.
• When the second dose has not been taken, patients should avoid the dose and not take the drug the following night.
• Dosing can be gradually adjusted, and dosages should be determined based on efficacy and tolerance.

Usage: Treatment of cataplexy (excessive daytime sleepiness) for patients with narcolepsy

Usual Adult Dose of Xywav for Idiopathic Hypersomnia

2 times a night routine:

Dose initial: 4.5 g orally daily, divided into two equal doses

The dosage can increase by 1.5 grammes (or 0.75 grammes per dose) every night each week.

Maintenance dosage: 6 to 9 g/day

Maximum dose: 9 g/day

Once a night, a routine:

Dose the initial 3 grammes orally every day, which is divided into 2 equal doses.

The dosage can be increased to 1.5 grammes (or 0.75 grammes per dose) every night at regular intervals over the course of a week.

Maintain dose 3 to 6 grammes per day

Maximum dose: 6 g/day

Comments:

• This medication can be administered in doses that are divided or in one dose.
• Dosing can be gradually titrated, and dosages should be based on efficacy and tolerance.
• Patients may be more responsive with the first dose administered at bedtime, and the second dose is administered between 2.5 and 4 hours later.

Usage: Treatment of idiopathic hypersomnia

Common Paediatric Dose to Treat Narcolepsy (7 Years and Over)

less than 20kg:

Specific dosage recommendations are not available.

20 to less than 30kg:

The initial dose is up to 2 grammes orally daily. Divided and given in 2 doses equal to up to 1 mg/dose

Dose for maintenance: It is possible to increase the dose by one gramme (OR 0.5 mg/dose) in the evening, orally, at 2 to 1 week intervals. This can be up to 6 grammes per day.

Maximum dose: 6 g/day

from 30 to 45kg:

The initial dose is up to 3 grammes orally daily. Divided and given in two equal doses of up to 1.5 grammes per dose

Maintaining dose It is possible to increase the dose by one gramme (OR 0.5 mg/dose) in the evening, orally, at 2–1 week intervals. This can be up to 7.5 grammes per day.

Maximum dose: 7.5 g/day

45 kg or more:

The initial dose is up to 4.5 grammes orally daily, divided into 2 doses equal to up to 2.25 grammes per dose.

Dose for maintenance: This dose can be raised by 1.5 grammes (OR 0.75 grammes/dose) each night orally at o 2-week int intervals and up to 9 grammes/day.

Maximum dose: 9 g/day

Comments:

• Patients who are sleeping more than 8 hours a night can be administered the first dose prior to bedtime or following an initial period of rest.
• Patients with a weight less than 20kg could receive lower maximums, initial maintenance, as well as total daily doses.
• Different doses might be needed for some patients in order to achieve the best performance from the treatment.
• Both doses must be diluted simultaneously in the evening.
• The first dose is best taken before bed, and the second dose is to be taken between 2.5 and four hours following the first dose. Some may have to set an alarm in order to get up to take the second dose.
• Patients are advised to remain in bed following the administration of every dose.
• In the event that the dose for the next day is not taken, patients should avoid the dose and not consume this medication until the next day.
• Dosing can be gradually titrated, and doses must be based on efficacy and tolerance.

Usage: Treatment of cataplexy (excessive daytime sleepiness) for patients suffering from narcolepsy

What happens if I miss the dose?

Do not miss the missed dose, and take your next dose at the normal time. Don't take two doses at once.Use Xywav only during your usual time of sleep (wait at least two hours after having eaten).

What will happen if I take excessively?

Get medical attention immediately, or contact us for help at the Poison Help Line at 1-800-222-1222. A fatal overdose of Xywav could be fatal.The symptoms of an overdose can be sweating, nausea, extreme confusion, loss of balance or coordination, or seizures (convulsions).

What should be avoided?

Don't drink or consume alcohol. Dangerous side effects or even death could happen.Do not take any other sleeping medication with Xywav.Xywav can cause drowsiness and could affect your ability to think or react. It is possible to feel sleepy the next day after taking this medication. Wait at least 6 hours or until you are completely awake before you drive or operate machinery, pilot an aircraft, or perform any activity that requires you to be alert and awake.

Side Effects of

See a doctor immediately. If you are experiencing symptoms that you are experiencing an allergic reaction, Xywav: hives, breathing difficulties, or swelling of your lips, face, and tongue.

See your doctor right away. If you suffer from:

• Breathing that is weak or shallow and ceases for only a few minutes
• Extreme drowsiness, feeling lightheaded;
• Sleeping (may cause injury) as well as waking up and having disturbed behaviour during the midnight;
• A seizure;
• Anxiety, depression, strange negative or uncomfortable thoughts
• Feelings of feeling devalued, feelings of low self-esteem, feelings of low self-esteem, you used to enjoy;
• Confusion, hallucinations, paranoia, and confusion (seeing as well as hearing);
• Fatigue, difficulty concentrating,
• Suicidal ideas or actions.

Common side effects of Xywav include:

• Sleeping, walking, eating, or talking in your sleep
• New sleep issues, bizarre dreams, night terrors
• Drowsiness, dizziness, tiredness, headache;
• Tremors, anxiety;
• Mouth dry, vomiting, dry mouth and vomiting, diarrhoea;
• Weight loss;
• Bedwetting (in kids).

It isn't a complete listing of all the side effects. Other side effects could occur. Consult your physician for advice regarding medical effects. You can report any adverse reactions to the FDA at 1-800-FDA-1088.

Interaction with other drugs

Side effects that are fatal can be experienced if you use Xywav together with other medications that can cause drowsiness or slow breathing. Ask your doctor before you take allergy or cold medications, opioids such as sedatives, muscle relaxers, seizure medication, or medications for anxiety, depression, or mental illnesses.If you stop or begin using divalproex (Depakote), your doctor might require adjusting the dose of Xywav.Other medications may interfere with magnesium, calcium, sodium oxybates, and potassium, such as prescription and over-the-counter medications, vitamins, and herbal products. Tell your physician about any other medication you're using.