FDA APPROVES XYWAV, THE FIRST DRUG FOR IDIOPATHIC HYPERSOMNIA, A CHRONIC SLEEP DISORDER

FDA APPROVES XYWAV, THE FIRST DRUG FOR IDIOPATHIC HYPERSOMNIA, A CHRONIC SLEEP DISORDER (IH)

Edited by, JASPER VICTORIA

Idiopathic hypersomnia is a sleep disorder that causes excessive sleepiness in the day, in individuals, though they had enough sleep in the night.

 FDA approves Xywav to Jazz Pharmaceuticals plc., for the indication of idiopathic hypersomnia in adults.

Xywav is a medication which is already approved and used for the treatment of excessive sleepiness in daytime or cataplexy (symptom of narcolepsy) in adults or patients above 7 years of age with narcolepsy. It is available as oral solution and contains calcium, magnesium, potassium and sodium oxybates. 

Xywav is approved to be used for idiopathic hypersomnia based on the evaluation of safety and efficacy in 154 patients aged between 19 and 75 years having idiopathic hypersomnia, by randomised, controlled withdrawal study. A group of patients who were administered with Xywav from the start of the study were made to take placebo instead of Xywav during the study. The patients who switched over from Xywav were observed to have excessive sleepiness and worsened symptoms of idiopathic hypersomnia due to the discontinuation or withdrawal of Xywav.

Gamma hydroxybutyrate or oxybate, the active moiety of Xywav is a substance prone for abuse or misuse and is associated with seizures, respiratory depression, reduced alertness, coma and /or death, which are serious and life threatening side effects. 

Xywav contains the labeled warning for CNS depression along with abuse or misuse of the drug. 21.4% of the patients who took Xywav had nausea, 10.4% had vomiting, 16.2% had head ache, 11.7% had dizziness, 10.4% had anxiety noted as the most prevalent adverse events during the clinical trial of Xywav.

The abuse or misuse of the medication and the CNS depression, being considered, Xywav needs due control and regulations for it to be rationally and safely used. Hence it can be sought only on producing a prescription from a registered or licensed medical professionals.