Patient Screening, Counseling, & Evaluation

All prescribers must screen, counsel, and evaluate their patients before prescribing XYREM1

Patient Screening, Counseling, & Evaluation

Patient Screening

Prescribers will screen each patient for certain medical conditions and concomitant medications.1

Prescribers will screen each patient for1:

  • History of alcohol or substance abuse
  • History of sleep-related breathing disorders
  • History of compromised respiratory function
  • Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents
  • History of depression or suicidality

The Certified Pharmacy will also specifically screen each patient for the following1:

  • Breathing disorders, including sleep apnea, asthma, and COPD
  • History of depression, suicidality, and drug or alcohol abuse
  • Seizure disorders
  • Hepatic impairment
  • High blood pressure, heart problems, kidney problems, or salt-restricted diet
  • Potentially interacting agents: sedative hypnotics; alcohol; sedating antidepressants, antipsychotics, or anti-epileptics; general anesthetics; muscle relaxants; opioid analgesics; valproate drugs; and illicit CNS depressants (eg, heroin, gamma-hydroxybutyrate [GHB])

The Certified Pharmacy will contact the prescriber with concerns about potential drug interactions or clinically significant medical conditions.1

Patient Counseling

Patient Counseling

Prescribers will counsel each patient on the serious risks, safe use, handling, and storage of XYREM.

Prescribers will1:

  • Review the contents of the XYREM® REMS Program Patient Quick Start Guide with each patient
  • Encourage all patients to read the XYREM Medication Guide and to ask any questions they may have regarding treatment with XYREM

Before initiating treatment with XYREM, prescribers will counsel each patient on1:

  • The serious risks associated with XYREM
  • Contraindications (alcohol, sedative hypnotics)
  • Risk of concomitant use of XYREM with alcohol, other CNS depressants, or other potentially interacting agents
  • Preparation and dosing instructions for XYREM
  • Risk of abuse and misuse associated with the use of XYREM
  • Risk of operating hazardous machinery, including automobiles or airplanes, for the first 6 hours after taking a dose of XYREM
  • Safe use, handling, and storage of XYREM
Patient Evaluation

Patient Evaluation

Prescribers will evaluate each patient within the first 3 months of starting XYREM, including the evalution of1:

  • Concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents
  • Serious adverse events
  • Signs of abuse and misuse such as an increase in dose or frequency of dosing; reports of lost, stolen, or spilled medication; and/or drug seeking behavior

It is recommended that patients be re-evaluated every 3 months thereafter while on XYREM therapy.1

Prescribers will report all potential serious adverse events, including CNS depression, respiratory depression, loss of consciousness, coma, and death, and any cases of suspected abuse, misuse, or diversion to Jazz Pharmaceuticals.1

To report suspected adverse reactions, contact Jazz Pharmaceuticals at
1-800-520-5568 or
jazzsafety@jazzpharma.com.

Need Help? Have Questions?

Call the XYREM REMS Program hotline anytime.

The Certified Pharmacy provides 24/7 toll-free access to a pharmacist to help answer any questions or concerns the prescriber, office staff, or patients may have regarding safety, dosing, and patient care.

Frequently Asked Questions

Prior to initiating XYREM, the prescriber should screen each patient for history of alcohol or substance abuse; history of sleep-related breathing disorders; history of compromised respiratory function; concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; and history of depression or suicidality.1

The Certified Pharmacy will also specifically screen each patient for breathing disorders such as sleep apnea, asthma, or COPD; history of depression, suicidality, and drug or alcohol abuse; seizure disorders; hepatic impairment; and high blood pressure, heart problems, kidney problems, or salt-restricted diet.1

In addition, the Certified Pharmacy will screen each patient for potentially interacting agents, including sedative hypnotics; alcohol; sedating antidepressants, antipsychotics, or anti-epileptics; general anesthetics; muscle relaxants; opioid analgesics; valproate drugs; and illicit CNS depressants (eg, heroin, gamma-hydroxybutyrate [GHB]). Remember to include a list of all nonprescription and prescription concomitant medications, including dosing information, on or with the XYREM REMS Program Prescription Form. The Certified Pharmacy will contact the prescriber with concerns about potential drug interactions or clinically significant medical conditions.1

Prescribers must counsel each patient on the serious risks, safe use, handling, and storage of XYREM by reviewing the contents of the XYREM REMS Program Patient Quick Start Guide, and encourage all patients to read the XYREM Medication Guide and to ask any questions they may have regarding treatment with XYREM.1

Before initiating treatment with XYREM, the prescriber should counsel each patient on the serious risks associated with XYREM; contraindications (alcohol, sedative hypnotics); risk of concomitant use of XYREM with alcohol, other CNS depressants, or other potentially interacting agents; preparation and dosing instructions for XYREM; risk of abuse and misuse associated with use of XYREM; risk of operating hazardous machinery, including automobiles or airplanes, for the first 6 hours after taking a dose of XYREM; and the safe use, handling, and storage of XYREM.1

Prescribers should evaluate each patient within the first 3 months of starting XYREM. During the evaluation, prescribers should assess for concomitant use of sedative hypnotics, other CNS depressants, or other potentially interacting agents; serious adverse events; and signs of abuse and misuse such as an increase in dose or frequency of dosing, reports of lost, stolen, or spilled medication, and/or drug seeking behavior.1

It is recommended that patients be re-evaluated every 3 months thereafter while on XYREM therapy.1