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Sonata (zaleplon) - N05CF03

Updated on site: 10-Oct-2017

Medication nameSonata
ATC CodeN05CF03
Substancezaleplon
ManufacturerMeda AB

Sonata is a medicine that contains the active substance zaleplon. It is available as capsules (white and brown: 5 mg; white: 10 mg).

Treatment with Sonata should be as short as possible and should last for no more than two weeks. Sonata is taken immediately before going to bed, or after the patient has gone to bed and is having difficulty falling asleep. The ec mmended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.

MedicinalThe maximum total dai y dose of Sonata is 10 mg. Patients should not take a second dose within a single night. No food shou d be eaten with or shortly before taking Sonata, because it can reduce the

medicine’s effects. Son ta must not be taken by children or by patients who have severe liver or kidney problems. For more information, see the Package Leaflet.

How does Sonata work?

The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiaz pines. Zaleplon is chemically different from the benzodiazepines, but it acts on the same receptors in the brain. It is a gamma-amino butyric acid (GABA) receptor agonist, which means that it attaches to the receptors for the neurotransmitter GABA and activates them. Neurotransmitters such as GABA are chemicals that allow nerve cells to communicate with each other. In the brain, GABA is involved in bringing about sleep. By activating its receptors, zaleplon increases GABA’s effects, which encourages sleep.

The powder in Sonata capsules is coloured with an intense dark blue dye, to prevent it being given to someone without their knowledge.

How has Sonata been studied?

Sonata has been studied in a total of 14 studies, involving nearly 3,500 adults and elderly patients. Five of these studies were comparative: Sonata was compared with placebo (a dummy treatment) or with zolpidem or triazolam (other medicines used in insomnia). The main studies lasted for two to four weeks. The main measure of effectiveness was the time taken to fall asleep. Some studies also looked at the time spent asleep and sleeping patterns.

What benefit has Sonata shown during the studies?

The time taken to fall asleep was reduced in adults taking Sonata 10 mg, and the effects were maintained for up to four weeks.

In elderly patients, the time taken to fall asleep was often decreased with Sonata 5 mg and was always decreased with Sonata 10 mg, when they were compared with placebo in the two-week studies. Sonata 10 mg was more effective than placebo in decreasing the time taken to fall asleep and increasing time spent asleep during the first half of the night.

Sonata also preserved sleep patterns in the studies that measured the time spent in different tages of sleep.

What is the risk associated with Sonata?

The most common side effects with Sonata (seen in between 1 and 10 patien s in 100) are amnesia (memory problems), paraesthesia (unusual sensations like pins and needles), somnolence (sleepiness) and dysmenorrhoea (painful menstruation). For the full list of all side effects reported with Sonata, see

other ingredients. It must not be used in patients with severe liv r or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathi g disorders), or in patients under 18 years of age.

The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata’s benefits are greater than its risks for theproducttreatment of pa ien s with insomnia who have difficulty falling asleep,

when the disorder is severe, disabling or subje ing the individual to extreme distress. The Committee recommended that Sonata be given marketing authorisation.

Other information about Sonata:

The European Commission g anted a marketing authorisation valid throughout the European Union for Sonata on 12 March 1999. The marketing authorisation was renewed on 12 March 2004 and on 12

This summary was last updated in 03-2009.

March 2009. The marketing authorisation holder is Meda AB.

TheMedicinalfull EPAR for So ta is available here.

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