What is Xyrem REMS?

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 26, 2024.

Official Answer by Drugs.com

Xyrem REMS refers to the program through which Xyrem can be prescribed by a doctor and through which Xyrem can be dispensed to a patient.

REMS stands for Risk Evaluation and Mitigation Strategy and the purpose of the program is to manage known or potential serious risks associated with a drug.
The FDA requires REMS programs for certain drugs to ensure that the benefits of the drug outweigh the risks.
The Xyrem REMS program is actually called the Xywav and Xyrem REMS.
The program ensures that only Xyrem (and Xywav) are dispensed only from the Certified Pharmacy.

Xyrem is a central nervous system depressant that may be used to treat cataplexy or excessive daytime sleepiness in adults and children aged 7 years and older with narcolepsy. Because Xyrem contains sodium oxybate (GHB), a known street drug with a high potential for abuse and serious side effects, the FDA has restricted who can prescribe it and who can dispense it.

Doctors must become certified in the Xyrem REMS program before they can prescribe Xyrem. To become certified, doctors must complete a one-time Xyrem REMS Program Prescriber Enrollment Form and submit it to the XYREM REMS Program via fax, email, or mail. They must also:

Be familiar with the Xyrem datasheet and prescribing information. This includes how to screen people for a history of alcohol or substance abuse or other medical conditions that may prohibit the use of Xyrem
Know how to educate and counsel people prescribed Xyrem and tell them about potential drug interactions
Use the correct Xyrem REMS program Prescription form for new prescriptions and also refills and renewals of Xyrem prescriptions
Provide new patients with a Xyrem REMS Program Patient Quick Start Guide.

Each new person prescribed Xyrem must complete a one-time enrollment in the Xyrem REMS Program Patient Enrollment Form and be able to answer patient questions about usage, storage, the risks associated with Xyrem, and where to obtain it from.

The prescription for Xyrem can only be filled by the central certified pharmacy, not your local pharmacy. This is the only pharmacy in the United States permitted to fill the prescription and send it directly to patients. This pharmacy also:

Gives the patient access to a pharmacist 24 hours a day, 7 days a week to answer questions about Xyrem
Provides an overnight delivery service (includes Saturdays) but only the patient or a designated adult can sign for the delivery
Follows up your prescription with a nurse case manager two days after delivery to answer questions.

How does Xyrem work for narcolepsy?

Xyrem's mechanism of action for narcolepsy is thought to involve binding to GABA_B and GHB receptors which enhances delta wave activity, improving the quality and quantity of deep sleep; however, the exact way it works is unknown. Continue reading

Is Xyrem a controlled substance / narcotic drug of abuse?

Yes, Xyrem is a controlled substance, and has a high potential to be abused. Xyrem contains sodium oxybate, also known as GHB, which is a known street drug of abuse. Xyrem is not a narcotic, the active ingredient sodium oxybate, is a central nervous system depressant. Continue reading

Does Xyrem cause weight gain or loss?

Xyrem (sodium oxybate), which is used to treat cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy, can cause weight loss. Weight loss is reported to be an adverse reaction associated with Xyrem treatment, but it is also seen as a beneficial effect of the drug because narcolepsy is linked to weight gain and obesity. Continue reading

What is Xyrem REMS?

Related questions

Read next

How does Xyrem work for narcolepsy?

Is Xyrem a controlled substance / narcotic drug of abuse?

Does Xyrem cause weight gain or loss?

See also:

Aimovig

Botox

Xywav

Nurtec ODT

Emgality

Inderal

Ajovy

Vyepti

Botox Cosmetic

Fremanezumab

Related medical questions

Drug information

Related support groups