Sonata 5mg and 10mg hard capsules
zaleplon
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Sonata is and what it is used for
- 2. Before you take Sonata
- 3. How to take Sonata
- 4. Possible side effects
- 5. How to store Sonata
- 6. Further Information
What Sonata Is And What It Is Used For
Sonata belongs to a class of substances called benzodiazepine-related drugs, which consists of preprations with hypnotic actions.
Sonata is a capsule that will help you to sleep. Sleeping problems do not usually last long, and most people only need a short course of treatment. The duration of treatment should usually vary from a few days to two weeks. If you still have problems sleeping after you have finished your capsules, contact your doctor again.
Before You Take Sonata
Do not take Sonata if you have
- hypersensitivity (an allergy) to zaleplon or to any other ingredients of Sonata, including indigo camine (E132)
- sleep apnoea (stopping breathing for short periods while asleep)
- severe liver disease
- myasthenia gravis (very weak or tired muscles)
- severe breathing or chest problems
If you are in any doubt about whether you have any of these conditions, do ask your doctor.
Children under 18 years of age should not take Sonata
Take special care with Sonata
- Never drink alcohol while you are being treated with Sonata. Alcohol can increase the undesirable effects of any medicine taken to help you sleep.
- Use with extreme caution if you have ever been addicted to drugs or alcohol.
- If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them.
- Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
- There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medications. This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
Taking other medicines
Do not take any other medicines without asking your doctor or pharmacist first. This includes medicines that can be bought without a prescription. Some can cause drowsiness and should not be taken while taking Sonata.
When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should. Be aware that such combinations may cause you to feel drowsy the next day. These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/sedatives, antidepressants), drugs used for strong pain relief (narcotic analgesics), drugs used for the treatment of seizures/convulsions (antiepileptic medicines), anaesthetics, and drugs used in the treatment of allergies (sedative antihistamines).
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach drug) or erythromycin (an antibiotic).
Taking Sonata with food and drink
It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly. Swallow the capsule(s) with a small glass of water. Never drink alcohol while you are being treated with Sonata (see "Take Special care with Sonata").
Pregnancy and breast-feeding
Tell your doctor if you are or intend to become pregnant. Sonata should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy.
Tell your doctor if you are breast-feeding. Sonata should not be taken at this time because there are not enough clinical data available to assess its safety during brest-feeding.
Driving and using medicines
If you feel drowsy the morning after taking Sonata you should avoid driving or operating machinery.
Important information about one of the ingredients of Sonata
WARNING: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Sonata
- Take the exact dose your doctor has prescribed. Do not change it without talking to your doctor first.
- There are different doses for people who are less than 65 years of age, those who are 65 or older, and those who have mild to moderate liver problems:
- Less than 65: Take one 10-mg capsule
- 65 or older: Take one 5-mg capsule
- Mild to moderate liver problems: Take one 5-mg capsule
- If you have a severe kidney disease, your doctor will have to evaluate if you can take Sonata.
- You should only take Sonata just before going to bed, or after you have gone to bed and you are having difficulty falling asleep. You should not take a second dose within a single night.
If you take more Sonata than you should
Contact a doctor immediately and say how many capsules have been taken.
If you forget to take Sonata
Do not worry, just take your next capsule at the usual time, then go on as before. Do not try and catch up on the doses you have missed.
If you stop taking Sonata
On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness. If you suffer from these symptoms, ask your doctor for advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Sonata can cause side effects, although not everybody gets them. If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.
Side effects that may occur in 1 or more out of 100 patients: drowsiness/sleepiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.
Less common side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; night restlessness; depression; agitation; irritability; confusion, abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, agressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremeties (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).
In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care.
Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Sonata
Keep out of the reach and sight of children.
Do not store above 30° C.
Do not use Sonata after the expiry date, which is stated on the carton. The expiry date refers to the last day of that month.
If you have any further questions, please consult your doctor or pharmacist.
Further Information
What Sonata contains
The active substance in each Sonata capsule is zaleplon 5 mg or 10mg.
The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).
Sonata has been designed so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Ingredients of the capsule shell 5mg: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), sodium lauryl sulphate and silicon dioxide. Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
Ingredients of the capsule shell 10mg: gelatin, titanium dioxide (E171), sodium lauryl sulphate and silicon dioxide. Printing inks on the shell contain the folowing (pink ink SW-1105): shellac, titanium dioxide (E171), ammonium hydroxide, red iron oxide (E172), yellow iron oxide (E172).
What Sonata looks like and contents of the pack
Sonata 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint "W", and white body, with gold imprint "5 mg". They are packed in blisters. Each pack contains 7, 10, 14 or 100 hard capsules (the 100 capsules presentation is to facilitate unit dose administration). Not all pack sizes may be marketed.
Sonata 10 mg hard capsules, which contain an intensely dark blue powder, have a white cap, with pink imprint "W", and white body, with pink imprint "10 mg". They are packed in blisters. Each pack contains 7, 10, 14 or 100 hard capsules (the 100 capsules presentation is to facilitate unit dose administration). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Company responsible for manufacturing Sonata (7, 10, 14) for Meda AB is
Company responsible for manufacturing Sonata (100) for Meda AB is
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved on 01/2008
PR301459
PAA001534
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