XYREM will be dispensed only by the central pharmacy that is specially certified.

Healthcare Providers who prescribe XYREM are specially certified.

Notable requirements of the XYWAV and XYREM REMS include the following: XYWAV and XYREM REMSīecause of the risks of central nervous system depression and abuse/misuse, XYREM is available only through a restricted distribution program called the XYWAV and XYREM REMS. Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely. The rapid onset of sedation, coupled with the amnestic features of XYREM, particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The active ingredient of XYREM, sodium oxybate or gamma hydroxybutyrate (GHB), is a Schedule I controlled substance. XYREM is a Schedule III controlled substance.

Patients should be queried about CNS depression-related events upon initiation of XYREM therapy and periodically thereafter. Also caution patients against these hazardous activities for at least 6 hours after taking XYREM. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYREM should be considered.Īfter first initiating treatment and until certain that XYREM does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. If use of these CNS depressants in combination with XYREM is required, dose reduction or discontinuation of one or more CNS depressants (including XYREM) should be considered. The concurrent use of XYREM with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. WARNINGS AND PRECAUTIONS Central Nervous System Depression

patients with succinic semialdehyde dehydrogenase deficiency.

combination with sedative hypnotics or alcohol.

Food and Drug Administration.CONTRAINDICATIONS XYREM is contraindicated for use in:

Other symptoms can include cataplexy, which is a sudden loss in muscle tone triggered by strong emotion. Narcolepsy is a sleep disorder that causes daily periods of excessive daytime sleepiness.

The most common adverse reactions to Wakix, occurring in 5 percent of adults or more, were insomnia, nausea, and anxiety. Harmony reports that Wakix is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. It has been commercially available in the U.S. Wakix is administered orally, once daily after waking up in the morning. It works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. About WakixĪccording to Harmony, Wakix is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The FDA previously approved Wakix for the treatment of excessive daytime sleepiness in adult patients with narcolepsy. Food and Drug Administration has approved Wakix (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. Guiding Principles for Industry Support.Young Investigators Research Forum (YIRF).Accredited Sleep Technologist Education Program (A-STEP).

Advanced Practice Registered Nurses and Physician Assistants (APRN PA).

Cataplexy treatment