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Active Substance: zaleplon
Common Name: zaleplon
ATC Code: N05CF03
Marketing Authorisation Holder: Meda AB
Active Substance: zaleplon
Status: Authorised
Authorisation Date: 1999-03-12
Therapeutic Area: Sleep Initiation and Maintenance Disorders
Pharmacotherapeutic Group: Psycholeptics

Therapeutic Indication

Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.

What is Sonata?

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

What is Sonata 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 Sonata 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.

How does Sonata 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 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 stages of sleep.

What is the risk associated with Sonata?

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 Sonata 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.

Other information about Sonata:

The European Commission granted 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 March 2009. The marketing authorisation holder is Meda AB.

Source: European Medicines Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.