According to the latest news from the FDA the combined use of Xyrem (sodium oxybate) with alcohol or psychotic drugs could put consumer’s health in jeopardy. The notification was issued by the FDA on 17, December 2012 in which the federal agency has alerted, warned and reminded patients, individuals and health care professionals that the use of Xyrem with alcohol or antidepressant drugs can cause severe breathing problems and could also markedly impair consciousness of the patients.

While talking to various industry experts and media professionals the representative of the FDA says the use of alcohol with Xyrem is a new contraindication added to the Xyrem label, which already contraindicates its use with insomnia drugs. The use of Xyrem with other CNS depressant drugs (drugs that affect the CNS and may lead to breathing problems) such as opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, general anesthetics, and muscle relaxants should generally be avoided.

The agency has also said that the use of Xyrem along with these products or other CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma, and death.

What is Xyrem?

XYREM is a medication approved for the treatment of excessive (too much) daytime sleepiness and the treatment of cataplexy (weak or paralyzed muscles), both in patients with narcolepsy. In studies with XYREM, about 80% of patients were also taking stimulants (medicines that help keep you alert)  XYREM is approved by the FDA (Food and Drug Administration).

Be conscious and consult your Doctor if you have any of the below mentioned conditions:

  • If you are under depression.
  • Have tried to hurt yourself or have thoughts about hurting yourself.
  • Have sleep apnea (short periods of not breathing while sleeping).
  • Have liver problems.
  • Have snoring, breathing, or lung problems.
  • Are on a low-salt diet or have high blood pressure, heart failure, or kidney problems.
  • Are breast-feeding.
  • Are pregnant or plan to become pregnant

Who should not take XYREM?

Do not take XYREM if you:

  • If you are already using sleep medicines or sedatives (medicines that cause sleepiness)
  • If you are suffering from a rare condition called SSADH (succinic semialdehyde dehydrogenase deficiency) that interferes with your ability to walk, speak, focus, and understand.

What are the possible side effects with XYREM?

  • These can include decreased breathing, and sleep apnea (short periods of no breathing while sleeping). Patients who already have breathing or lung problems have a higher chance for breathing problems with XYREM.
  • Various mental ailments
  • Confusion
  • Psychosis (seeing or hearing things that are not real)
  • Agitation (emotionally very disturbed or upset)
  • Abnormal thinking (unusual or disturbing thoughts)
  • Depression
  • Thoughts of killing