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Author: Meda AB


Long information

What is it?

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

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Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Sonata is used for the treatment of adults with insomnia who have difficulty falling asleep. It is used only when the insomnia is severe, disabling or causing extreme distress.
The medicine can only be obtained with a prescription.

How is it used?

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 recommended dose is 10 mg, except for the elderly or patients with mild or moderate liver disease, who should take 5 mg.
The maximum total daily dose of Sonata is 10 mg. Patients should not take a second dose within a single night. No food should be eaten with or shortly before taking Sonata, because it can reduce the medicine?s effects. Sonata must not be taken by children or by patients who have severe liver or kidney problems. For more information, see the Package Leaflet.

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How does it work?

The active substance in Sonata, zaleplon, belongs to a group of medicines that are related to the benzodiazepines. 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 it 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 benefits has it 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 stages of sleep.

What is the risk associated?

The most common side effects with Sonata (seen in between 1 and 10 patients 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 the Package Leaflet.
Sonata should not be used in people who may be hypersensitive (allergic) to zaleplon or any of the other ingredients. It must not be used in patients with severe liver or kidney problems, sleep apnoea syndrome (frequent interruption of breathing during sleep), myasthenia gravis (a disease causing muscle weakness) or severe respiratory insufficiency (breathing disorders), or in patients under 18 years of age.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Sonata?s benefits are greater than its risks for the treatment of patients with insomnia who have difficulty falling asleep, when the disorder is severe, disabling or subjecting the individual to extreme distress. The Committee recommended that Sonata be given marketing authorisation.

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