Human medicines European public assessment report (EPAR): Ozawade, pitolisant, Date of authorisation: 01/09/2021, Revision: 7, Status: Authorised

Overview

Ozawade is a medicine used to improve wakefulness and reduce excessive daytime sleepiness in adults with obstructive sleep apnoea. Obstructive sleep apnoea is the repeated interruption of breathing during sleep due to airways becoming blocked. Ozawade is used when other treatments, such as continuous positive airway pressure (CPAP, use of a ventilator to keep the airways open) have not satisfactorily improved excessive daytime sleepiness or cannot be tolerated by the patient. Ozawade contains the active substance pitolisant Expand section Collapse section How is Ozawade used? Ozawade can only be obtained with a prescription. Treatment should be started by a healthcare professional experienced in the treatment of obstructive sleep apnoea and in the management of risks associated with cardiovascular disease (affecting the heart and blood circulation). Ozawade is available as tablets to be taken once a day in the morning with food. The starting dose is 4.5 mg once a day. Depending on how well the medicine works, the dose may be increased weekly, up to a maximum of 18 mg once a day by week three. Ozawade should always be used at the lowest effective dose. For more information about using Ozawade, see the package leaflet or contact your doctor or pharmacist. How does Ozawade work? The active substance in Ozawade, pitolisant, works by attaching to receptors (targets) in the brain called 'histamine H3 receptors'. This increases the activity of certain brain cells called 'histamine neurons', which are important for keeping the body awake. Pitolisant also increases levels of the neurotransmitters acetylcholine, dopamine and noradrenaline in the brain. Neurotransmitters are chemical messengers that allow nerve cells to communicate with each other. Since these neurotransmitters are involved in maintaining alertness and arousal, increasing their levels may improve wakefulness. What benefits of Ozawade have been shown in studies? Ozawade has been found to improve excessive daytime sleepiness in adults with obstructive sleep apnoea in two main studies. The first study involved 244 patients with obstructive sleep apnoea who were receiving CPAP therapy, but whose excessive daytime sleepiness had not improved satisfactorily. Patients received either Ozawade or placebo (a dummy treatment) in addition to CPAP therapy and excessive daytime sleepiness was measured using a standard daytime sleepiness scale called the Epworth sleepiness scale. After 12 weeks of treatment, daytime sleepiness was reduced by an average of 5.5 points on the Epworth sleepiness scale in patients receiving Ozawade and 2.8 points in those receiving placebo. The second study, involving 268 patients who could not tolerate or refused CPAP therapy, found that patients receiving Ozawade had an average reduction in daytime sleepiness of 6.3 points on the Epworth sleepiness scale after 12 weeks, compared with 3.6 points in those receiving placebo. What are the risks associated with Ozawade? The most common side effect with Ozawade (which may affect more than 1 in 10 people) is headache. Common side effects (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), nausea (feeling sick), anxiety, abdominal (belly) pain, vertigo (a spinning sensation) and diarrhoea. For the full list of side effects of Ozawade, see the package leaflet. Ozawade must not be used by people who have severely reduced liver function or by women who are breastfeeding. For the full list of restrictions, see the package leaflet. Why is Ozawade authorised in the EU? Ozawade was shown to improve excessive daytime sleepiness in people with obstructive sleep apnoea, both in those receiving CPAP and in those in whom CPAP did not work well enough or was not tolerated. The side effects of the medicine were mostly mild or moderate. The European Medicines Agency therefore decided that Ozawade's benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Ozawade? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ozawade have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Ozawade are continuously monitored. Suspected side effects reported with Ozawade are carefully evaluated and any necessary action taken to protect patients. Other information about Ozawade Ozawade received a marketing authorisation valid throughout the EU on 1 September 2021. Ozawade : EPAR - Medicine overview English (EN) (129.15 KB - PDF) First published: 14/10/2021 View Other languages (22) български (BG) (155.98 KB - PDF) First published: 14/10/2021 View español (ES) (131.54 KB - PDF) First published: 14/10/2021 View čeština (CS) (153.64 KB - PDF) First published: 14/10/2021 View dansk (DA) (130.21 KB - PDF) First published: 14/10/2021 View Deutsch (DE) (134.93 KB - PDF) First published: 14/10/2021 View eesti (ET) (119.33 KB - PDF) First published: 14/10/2021 View ελληνικά (EL) (157.04 KB - PDF) First published: 14/10/2021 View français (FR) (133.24 KB - PDF) First published: 14/10/2021 View hrvatski (HR) (151.5 KB - PDF) First published: 14/10/2021 View italiano (IT) (131.56 KB - PDF) First published: 14/10/2021 View latviešu (LV) (161.3 KB - PDF) First published: 14/10/2021 View lietuvių (LT) (154.86 KB - PDF) First published: 14/10/2021 View magyar (HU) (152.39 KB - PDF) First published: 14/10/2021 View Malti (MT) (154.31 KB - PDF) First published: 14/10/2021 View Nederlands (NL) (130.92 KB - PDF) First published: 14/10/2021 View polski (PL) (154.01 KB - PDF) First published: 14/10/2021 View português (PT) (143.77 KB - PDF) First published: 14/10/2021 View română (RO) (163.06 KB - PDF) First published: 14/10/2021 View slovenčina (SK) (152.2 KB - PDF) First published: 14/10/2021 View slovenščina (SL) (163.99 KB - PDF) First published: 14/10/2021 View suomi (FI) (128.21 KB - PDF) First published: 14/10/2021 View svenska (SV) (129.93 KB - PDF) First published: 14/10/2021 View Ozawade : EPAR - Risk management plan summary English (EN) (196.63 KB - PDF) First published: 14/10/2021 View

Product information

Ozawade : EPAR - Product information English (EN) (489.12 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Other languages (24) български (BG) (543.04 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View español (ES) (483.9 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View čeština (CS) (512.26 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View dansk (DA) (488.74 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Deutsch (DE) (510.39 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View eesti (ET) (500.13 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View ελληνικά (EL) (544.37 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View français (FR) (483.61 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View hrvatski (HR) (511.25 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View italiano (IT) (504.42 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View latviešu (LV) (519.2 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View lietuvių (LT) (523.53 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View magyar (HU) (518.55 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Malti (MT) (554.49 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Nederlands (NL) (491.21 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View polski (PL) (538.47 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View português (PT) (485.09 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View română (RO) (510.73 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View slovenčina (SK) (529.42 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View slovenščina (SL) (507.86 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View suomi (FI) (550.72 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View svenska (SV) (483.62 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Íslenska (IS) (492.65 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View norsk (NO) (484.82 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Latest procedure affecting product information: VR/0000341691 23/07/2026 This medicine's product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Ozawade : EPAR - All authorised presentations English (EN) (63.76 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Other languages (24) български (BG) (70.32 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View español (ES) (65.13 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View čeština (CS) (67.13 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View dansk (DA) (65.89 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Deutsch (DE) (71.94 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View eesti (ET) (64.19 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View ελληνικά (EL) (69.75 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View français (FR) (63.62 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View hrvatski (HR) (64.72 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View italiano (IT) (65.08 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View latviešu (LV) (67.32 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View lietuvių (LT) (67.83 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View magyar (HU) (67.63 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Malti (MT) (67.64 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Nederlands (NL) (64.02 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View polski (PL) (67.95 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View português (PT) (65.29 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View română (RO) (65.67 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View slovenčina (SK) (68.29 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View slovenščina (SL) (65.61 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View suomi (FI) (63.45 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View svenska (SV) (65.16 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View Íslenska (IS) (66.91 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View norsk (NO) (65.54 KB - PDF) First published: 14/10/2021 Last updated: 06/08/2026 View

Product details

Name of medicine Ozawade Active substance pitolisant International non-proprietary name (INN) or common name pitolisant Therapeutic area (MeSH) Sleep Apnea, Obstructive Anatomical therapeutic chemical (ATC) code N07XX11 Pharmacotherapeutic group Other nervous system drugs Therapeutic indication Ozawade is indicated to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adult patients with obstructive sleep apnoea (OSA)

Authorisation details

EMA product number EMEA/H/C/005117 Marketing authorisation holder Bioprojet Pharma 115 Rue d'Aboukir Paris 75002 France Opinion adopted 20/05/2021 Marketing authorisation issued 01/09/2021 Revision 7

Assessment history

Expand section Collapse section Changes since initial authorisation of medicine Ozawade : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (184.01 KB - PDF) First published: 05/09/2025 Last updated: 06/08/2026 View Ozawade : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (157.83 KB - PDF) First published: 14/01/2022 Last updated: 18/11/2025 View Initial marketing authorisation documents Ozawade : EPAR - Public assessment report Adopted Reference Number: EMA/375687/2021 English (EN) (1.88 MB - PDF) First published: 14/10/2021 View CHMP summary of positive opinion for Ozawade Adopted Reference Number: EMA/CHMP/153636/2021 English (EN) (133.7 KB - PDF) First published: 21/05/2021 View

More information on Ozawade

A multi-center, observational prospective post-authorization safety study to compare the cardiovascular risks and long-term safety of OZAWADE® in patients with obstructive sleep apnoea treated or not by primary therapy and exposed or not to OZAWADE® when used in routine medical practice - post-authorisation study