Xyrem

Cataplexy, Narcolepsy, Idiopathic Hypersomnia
Treatment
9 Active Studies for Xyrem

What is Xyrem

Sodium oxybateThe Generic name of this drug
Treatment SummarySodium oxybate (Xyrem) is a medication used to treat cataplexy and excessive daytime sleepiness associated with narcolepsy. It is a form of gamma hydroxybutyric acid (GHB), a natural chemical found in the body and a metabolite of the neurotransmitter GABA. Its purpose is not fully understood, but it is believed that it works by affecting nerve cells in the brain. Sodium oxybate has a complicated way of being absorbed by the body and has a risk of being misused, so it is strictly regulated and requires people to sign up for the sodium oxybate REMs
Xyremis the brand name
image of different drug pills on a surface
Xyrem Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Xyrem
Sodium oxybate
2002
3

Effectiveness

How Xyrem Affects PatientsSodium oxybate can help people with narcolepsy sleep better at night and be more alert during the day, as well as helping to reduce cataplexy. Higher doses can reduce excessive daytime sleepiness. Research suggests that sodium oxybate helps people sleep more deeply and continuously. It is a type of central nervous system depressant, meaning it can cause serious breathing problems and carries a risk of substance misuse, abuse, addiction, withdrawal, and overdoses. Sodium oxybate also increases dopamine levels and serotonin turnover, and stimulates growth hormone release. This makes it a potential target for misuse as a bodybuilding supplement. In people
How Xyrem works in the bodySodium oxybate works by activating certain receptors in the body, which releases a nerve-stimulating chemical called glutamate. At higher doses, it activates receptors that help regulate sleep-wake cycles, attention and vigilance. It also changes into GABA, which helps modulate two other types of receptors.

When to interrupt dosage

The suggested dose of Xyrem is determined by the diagnosed condition, such as Excessive Daytime Sleepiness, Narcolepsy and Cataplexy. The quantity of dosage is adjustable contingent upon the method of delivery listed in the table underneath.
Condition
Dosage
Administration
Narcolepsy
, 500.0 mg/mL
, Solution, Solution - Oral, Oral
Idiopathic Hypersomnia
, 500.0 mg/mL
, Solution, Solution - Oral, Oral
Cataplexy
, 500.0 mg/mL
, Solution, Solution - Oral, Oral

Warnings

Xyrem Contraindications
Condition
Risk Level
Notes
Pulse Frequency
Do Not Combine
Succinate-semialdehyde dehydrogenase
Do Not Combine
Pulse Frequency
Do Not Combine
There are 20 known major drug interactions with Xyrem.
Common Xyrem Drug Interactions
Drug Name
Risk Level
Description
Azelastine
Major
Sodium oxybate may increase the central nervous system depressant (CNS depressant) activities of Azelastine.
Ethanol
Major
Sodium oxybate may increase the central nervous system depressant (CNS depressant) activities of Ethanol.
Oliceridine
Major
The risk or severity of hypotension, sedation, death, somnolence, and respiratory depression can be increased when Sodium oxybate is combined with Oliceridine.
Thalidomide
Major
Sodium oxybate may increase the central nervous system depressant (CNS depressant) activities of Thalidomide.
Daridorexant
Minor
The risk or severity of CNS depression can be increased when Sodium oxybate is combined with Daridorexant.
Xyrem Toxicity & Overdose RiskThe lowest toxic dose of GHB in rats is 9690 mg/kg. If someone takes an excessive amount of GHB, they may become disoriented, confused, agitated, and/or unresponsive, and have trouble with motor skills, blurred vision, sweating, and headaches. They may also experience deeper levels of unconsciousness, seizures, slow or shallow breathing, a slow heart rate, and/or low body temperature. In rare cases, an overdose can be fatal. There is no cure for GHB overdose and treatment consists of supportive care and possible decontamination.
image of a doctor in a lab doing drug, clinical research

Xyrem Novel Uses: Which Conditions Have a Clinical Trial Featuring Xyrem?

17 active trials are presently assessing the potential of Xyrem to address Cataplexy, Excessive Daytime Sleepiness and Narcolepsy.
Condition
Clinical Trials
Trial Phases
Cataplexy
0 Actively Recruiting
Idiopathic Hypersomnia
7 Actively Recruiting
Phase 4, Phase 3, Phase 1, Phase 2
Narcolepsy
2 Actively Recruiting
Not Applicable, Phase 1

Xyrem Reviews: What are patients saying about Xyrem?

4.7Patient Review
3/20/2016
Xyrem for Recurring Sleep Episodes During the Day
This medication has been vital in helping me to keep my job. I have narcolepsy with cataplexy, and without this drug I would constantly be asleep.
4.3Patient Review
9/21/2014
Xyrem for Recurring Sleep Episodes During the Day
This medicine has changed my life for the better. It took some time to get the dosage right, but now that I have, I sleep better than ever and no longer experience fibro-like symptoms.
4.3Patient Review
1/24/2015
Xyrem for Muscle Weakness associated with Sleeping Disease
I've taken Zyrem for eight years now. The main active ingredient is salt, so make sure you stay hydrated while taking it! It's also very short-acting, which I appreciate.
2.7Patient Review
2/20/2014
Xyrem for Recurring Sleep Episodes During the Day
This drug can be difficult to predict; sometimes it works well, other times you're in for a long night of pain. I also don't love that you have to get up in the middle of the night to take another dose.
2.7Patient Review
5/12/2014
Xyrem for Recurring Sleep Episodes During the Day
I was only able to get three hours of sleep each time I took this medication, but the side effects weren't worth it.
1Patient Review
4/3/2021
Xyrem for Muscle Weakness associated with Sleeping Disease
I was really out of it for the months I took this medication, and lost a lot of weight. It got to the point where my family was taking pictures with me at Thanksgiving, but not with anyone else. That's when I knew I had to stop.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about xyrem

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does Xyrem do to the body?

"Xyrem slows down activity in your central nervous system, which is called CNS depression. Even when you take Xyrem at the doses your doctor prescribes, the drug causes this side effect. CNS depression can affect your motor skills, judgment, and thinking."

Answered by AI

What kind of drug is Xyrem?

"The prescription drug Xyrem is the sodium salt of gamma-hydroxybutyrate (GHB). GHB is a Schedule I controlled substance under the Controlled Substances Act and has not been approved for any medical use. GHB has the potential for abuse, such as in cases of sexual assault."

Answered by AI

Is Xyrem a narcotic?

"Xyrem has a high potential for abuse and is available only from a certified doctor and pharmacy. It is known by the street name GHB and is not a narcotic."

Answered by AI

Is Xyrem addictive?

"Xyrem may impede or discontinue your respiration, even at customary amounts or on the off chance that you are likewise taking stimulant medication. Xyrem might be addictive. Abuse can bring about dependence, overdose, or demise. Keep the medication in a spot where others can't get to it."

Answered by AI

Clinical Trials for Xyrem

Image of Takeda Site 11 in Redwood City, United States.

TAK-360 for Excessive Daytime Sleepiness

18 - 70
All Sexes
Redwood City, CA
Idiopathic Hypersomnia (IH) is a condition where people feel extremely sleepy during the day, especially in the morning, even if they sleep a lot at night. They may have trouble waking up in the morning, no matter how much they sleep (sometimes more than 11 hours per day), and they can't help feeling tired, even after taking daytime naps. Because of this sleepiness, they may have trouble focusing, thinking clearly, or keeping up with daily activities. They may also have symptoms like dizziness or feeling lightheaded. Orexin is a chemical made in the brain that helps keep a person awake and alert. TAK-360 acts like orexin. Previous studies have shown that medicines that act like orexin may keep people awake. The main aim of this study is to learn how safe TAK-360 is and how well adults with IH tolerate it. Researchers also want to find out if TAK-360 can help people with IH stay awake and how much TAK-360 is needed to do that. Participants will be randomly (by chance, like drawing names from a hat) chosen to receive either TAK-360 or a placebo. The placebo looks just like TAK-360 but does not have any medicine in it. Using a placebo helps researchers learn about the real effect of the treatment.
Phase 2
Recruiting
Takeda Site 11 (+13 Sites)Study DirectorTakeda
Have you considered Xyrem clinical trials? We made a collection of clinical trials featuring Xyrem, we think they might fit your search criteria.Go to Trials
Image of PROSOMNIA Sleep Health and Wellness in Aventura, United States.

PROSOMNIA Sleep Therapy for Chronic Insomnia

18 - 65
All Sexes
Aventura, FL
This clinical trial aims to evaluate the safety and efficacy of PROSOMNIA Sleep Therapy (PSTx) for individuals suffering from chronic insomnia, sleep deprivation, and REM sleep disorders. Chronic insomnia, characterized by difficulty falling or staying asleep, significantly affects patients and quality of life, mood, and cognitive function. REM sleep disorders, in which the body struggles to enter or maintain restful REM sleep, can worsen these issues. The trial introduces a novel therapy using anesthesia-induced sleep, targeting sleep homeostasis and improving sleep architecture. Objectives: The primary goals of the trial are to determine: 1. Whether PROSOMNIA Sleep Therapy increases the quality of REM sleep. 2. Whether PSTx increases the duration of REM and/or NREM sleep. 3. Whether PSTx decreases the time it takes participants to fall asleep (sleep onset latency). Participants will receive ONE (1) PROSOMNIA Sleep Therapy session lasting between 60-120 minutes. Each session uses Diprivan/Propofol to induce sleep, and is monitored via an EEG to ensure proper sleep stages, particularly REM sleep. Participant Criteria: Inclusion: Adults aged 18-65 with diagnosed or undiagnosed chronic insomnia or sleep deprivation. Exclusion: Patients with severe obesity, significant cardiovascular, neurological, or psychiatric conditions, or those with an ASA status above II. Study Design: This trial is non-randomized, single-arm and open-label, with all participants receiving the PSTx. The trial does not include a comparison group, as the focus is on evaluating the immediate, direct effects of the therapy. Participants will undergo continuous EEG monitoring during therapy sessions, allowing researchers to track brain activity and sleep stages in real-time. This method ensures that sleep cycles, particularly REM sleep, are optimized for therapeutic benefit. Therapy Methodology: PROSOMNIA Sleep Therapy leverages anesthesia to mimic natural sleep patterns and enhance the efficiency of REM sleep. Diprivan/Propofol is used to induce REM sleep, while EEG monitoring tracks and maintains proper sleep architecture throughout the session. The therapy promotes the clearance of adenosine, a compound that builds up during wakefulness and drives the need for sleep. Adenosine is cleared during REM sleep, reducing sleep pressure and improving cognitive function. Outcome Measures: Primary Outcomes: Researchers will measure the increase in REM sleep duration, improvement in sleep quality (via self-reported questionnaires), and a reduction in sleep onset latency. Secondary Outcomes: These include changes in mood, cognitive function, and blood serum uric acid levels. Patient-reported outcomes will also be tracked through tools like the PROSOMNIA Sleep Quiz, which is specifically designed for PSTx. Significance: Chronic insomnia and REM sleep disorders affect millions globally, leading to cognitive impairment, mood disturbances, and poor overall health. Traditional treatments, including pharmacological approaches and Cognitive Behavioral Therapy for Insomnia (CBT-I), often provide suboptimal results for many individuals. PSTx offers a novel, therapeutic approach to restoring sleep balance and enhancing the overall quality of sleep, particularly for those who have not responded to conventional treatments. Study Process: Recruitment and Baseline Assessments: Participants undergo a comprehensive sleep assessment, including sleep questionnaires and polysomnography, to establish a baseline for sleep quality and duration. Blood serum uric acid levels will also be measured to track any biochemical changes due to therapy. Therapy Sessions: Only one (1) PROSOMNIA Sleep Therapy session will be administered, with the session lasting between 60-120 minutes. Diprivan/Propofol is used to induce sleep, and EEG will monitor brain activity to ensure the proper balance of sleep stages. Post-Therapy Follow-up: Follow-up assessments will occur at 24 hours, 7 days, and 30 days post-treatment. Researchers will analyze the therapy effects on REM sleep, mood, cognitive function, and other health indicators. Potential Implications: If successful, this trial could revolutionize how we treat sleep disorders by targeting the underlying mechanisms of sleep pressure and REM sleep disruption. PROSOMNIA Sleep Therapy may offer a safe, effective, and immediate alternative for patients who have exhausted other treatment options. Key Concepts: Homeostatic sleep drive, (Process S), caused by adenosine buildup during wakefulness, is disrupted by chronic insomnia. This impacts cognitive function health and recovery. Anesthesia-induced REM sleep via PSTx helps regulate this homeostatic sleep stage, offering deeper and more restorative sleep compared to other sleep therapies. The study uses statistical methods like ANOVA and Chi-square to measure outcomes.
Phase 1
Waitlist Available
PROSOMNIA Sleep Health and Wellness (+1 Sites)Nyree Penn, MHSc., CAA, Master of Health ScienceNyree Penn
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