Xyrem

sodium oxybate

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This is a summary of the European public assessment report (EPAR) for Xyrem. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Xyrem.

What is Xyrem?

Xyrem is an oral solution, which contains the active substance sodium oxybate (500 mg/ml).

What is Xyrem used for?

Xyrem is used to treat adults who have narcolepsy with cataplexy. Narcolepsy is a sleep disorder that causes excessive daytime sleepiness. Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise. Cataplexy can sometimes cause a patient to collapse.

The medicine can only be obtained with a special prescription.

How is Xyrem used?

Xyrem treatment should be started and given under the guidance of a doctor who has experience in the treatment of sleep disorders. Because sodium oxybate can be abused, doctors should check for a history of or susceptibility to drug abuse before treatment, and monitor for misuse and abuse during treatment.

Xyrem is given at a dose of 4.5 to 9 g per day in two equally divided doses. The maximum daily dose is 9 g. Patients should usually start with two doses of 2.25 g (4.5 ml) per day. The dose is then adjusted at one- to two-week intervals depending on the patient’s response. The starting dose should be halved in patients who have problems with their liver. Patients who have problems with their kidneys should consider a low sodium diet. Patients taking Xyrem should avoid alcohol, as it can increase Xyrem’s effects.

Xyrem is supplied with a measuring device and a cup. Before taking the medicine, the patient should dissolve the dose in water to make up a drink. The first dose of the day is taken at bedtime, at least two to three hours after food. The second dose is taken 2.5 to 4 hours later. Both doses should be prepared at the same time before the patient goes to bed. For more information, see the package leaflet.

How does Xyrem work?

The active substance in Xyrem, sodium oxybate, is a central-nervous-system depressant. The precise way in which it works is not known, but it is thought to attach to receptor molecules on the surface of some cells in the brain. This leads to changes in the activity of the brain, bringing about ‘delta’ (slow) brain waves and night-time sleep. When taken at bedtime, Xyrem increases deep sleep and increases the amount of time spent asleep at night, whilst reducing the number of sleeping periods during the day. This improves the symptoms of narcolepsy.

How has Xyrem been studied?

The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies. In all of the studies, Xyrem was given at a daily dose between 3 and 9 g and was compared with placebo (a dummy treatment). The first study (136 patients) examined the effects of Xyrem on the number of cataplexy attacks over four weeks of treatment. The second study, including 56 patients who had been taking Xyrem for at least six months, compared the effects of continuing to take Xyrem at the same dose as before, with the effects of switching to placebo. The study measured the number of cataplexy attacks over two weeks. The other two studies (516 patients) examined the effects of Xyrem on excessive daytime sleepiness and other symptoms of narcolepsy, either taken alone or as an add-on to the patient’s existing dose of modafinil (a stimulant medicine used to treat narcolepsy). The main measure of effectiveness was the change in daytime sleepiness.

The effects of Xyrem have also been studied in fibromyalgia patients with moderate to severe symptoms in two short-term (12-week) studies in 1,121 patients, and one long-term (up to nine months) study in 560 patients. Fibromyalgia is a disease of unknown origin causing long-lasting, widespread pain and painful responses to touch. The main measure of effectiveness was based on reduction of pain severity and improvement in function.

What benefit has Xyrem shown during the studies?

Xyrem was more effective than placebo in reducing symptoms. In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared with a fall of 4.3 per week in the patients taking placebo. The second study showed that Xyrem continued to prevent cataplexy attacks after long-term treatment: there was no change over two weeks in the number of attacks in the patients continuing to take Xyrem, compared to an increase of 21.0 attacks in those switching to placebo. Xyrem also reduced excessive daytime sleepiness in patients who continued to take modafinil, as well as in those who took Xyrem alone.

The data obtained in the fibromyalgia studies did not support the use of Xyrem in this condition in the European population.

What is the risk associated with Xyrem?

The most common side effects with Xyrem (seen in more than 1 patient in 10) are dizziness, headache and nausea (feeling sick). Nausea is more common in women than in men. Xyrem can also cause respiratory depression (inhibition of breathing). For the full list of all side effects reported with Xyrem, see the package leaflet.

Xyrem should not be used in people who may be hypersensitive (allergic) to sodium oxybate or any of the other ingredients. It must not be used in patients with major depression, in patients with ‘succinic-semialdehyde-dehydrogenase deficiency’ (a rare metabolic disease), or in patients being treated with opioids (such as some painkillers) or barbiturates (such as some anaesthetics and medicines used to prevent seizures). Because sodium oxybate can be abused, doctors must carefully monitor patients using Xyrem.

Why has Xyrem been approved?

The CHMP decided that Xyrem’s benefits are greater than its risks. Although the 9-g dose was the most effective, it was linked to high levels of side effects, so the Committee recommended a starting dose of 4.5 g per day. Since the effective dose is close to the dose at which side effects become serious, increases in dose must be carried out strictly and under the supervision of a doctor specialised in the treatment of sleep disorders. The Committee recommended that Xyrem be given marketing authorisation.

Which measures are being taken to ensure the safe use of Xyrem?

The company that makes Xyrem will minimise the risk of abuse of Xyrem by providing educational materials to healthcare workers and patients, strictly controlling the distribution of the medicine, and monitoring its use.

Other information about Xyrem

The European Commission granted a marketing authorisation valid throughout the European Union for Xyrem to UCB Pharma Ltd on 13 October 2005. After five years, the marketing authorisation was renewed for a further five years.

For more information about treatment with Xyrem, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Xyrem : EPAR - Summary for the public BG = bălgarski 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public ES = español 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public CS = čeština 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public DA = dansk 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public DE = Deutsch 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public ET = eesti keel 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public EL = elliniká 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public EN = English 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public FR = français 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public IT = italiano 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public LV = latviešu valoda 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public LT = lietuvių kalba 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public HU = magyar 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public MT = Malti 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public NL = Nederlands 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public PL = polski 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public PT = português 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public RO = română 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public SK = slovenčina 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public SL = slovenščina 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public FI = suomi 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public SV = svenska 2007-07-06 2014-07-17
Xyrem : EPAR - Summary for the public HR = Hrvatski 2007-07-06 2014-07-17

This EPAR was last updated on 05/11/2015 .

Authorisation details

Product details

Product details for Xyrem
NameXyrem
Agency product numberEMEA/H/C/000593
Active substance

sodium oxybate

International non-proprietary name (INN) or common name

sodium oxybate

Therapeutic area CataplexyNarcolepsy
Anatomical therapeutic chemical (ATC) code N07XX04

Publication details

Publication details for Xyrem
Marketing-authorisation holder

UCB Pharma Ltd

Revision23
Date of issue of marketing authorisation valid throughout the European Union13/10/2005

Contact address:

UCB Pharma Ltd
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom

Product information

Product information

04/08/2016  Xyrem -EMEA/H/C/000593 -II/0061

Name Language First published Last updated
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14
Xyrem : EPAR - Product Information HR = Hrvatski 2009-12-07 2016-09-14

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  
Xyrem : EPAR - All Authorised presentations HR = Hrvatski 2008-12-10  

Pharmacotherapeutic group

Other nervous-system drugs

Therapeutic indication

Treatment of narcolepsy with cataplexy in adult patients.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Xyrem : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-09  
Xyrem : EPAR - Scientific Discussion HR = Hrvatski 2006-08-09  

Authorised

This medicine is approved for use in the European Union

More information on Xyrem

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 3 February 2003. Upon request of the marketing-authorisation holder, Xyrem has now been removed from the Community register of orphan medicinal products.