Sonata

1

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
SUMMARY OF PRODUCT CHARACTERISTICS 

 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Sonata 5 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each capsule contains 5 mg of zaleplon. 
 
Excipient with known effect: Lactose monohydrate 54 mg. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Capsule, hard. 
Capsules have an opaque white and opaque light brown hard shell with the strength “5 mg”. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of administration 
 
For adults, the recommended dose is 10 mg.  
 
Treatment should be as short as possible with a maximum duration of two weeks. 
 
Sonata can be taken immediately before going to bed or after the patient has gone to bed and is 
experiencing difficulty falling asleep. As administration after food delays the time to maximal plasma 
concentration by approximately 2 hours no food should be eaten with or shortly before intake of 
Sonata. 
 
The total daily dose of Sonata should not exceed 10 mg in any patient. Patients should be advised not 
to take a second dose within a single night. 
 
Elderly 
Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose 
of Sonata. 
 
Paediatric patients 
Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3). 
 
Hepatic impairment 
As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with 
Sonata 5 mg. For severe hepatic impairment see section 4.3. 
 

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Renal impairment 
No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata 
pharmacokinetics is not altered in such patients. Severe renal impairment is contraindicated (see 
section 4.3.). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Severe hepatic impairment 
Severe renal impairment 
Sleep apnoea syndrome 
Myasthenia gravis 
Severe respiratory insufficiency 
Children and adolescents (under 18 years of age) 
 
4.4 Special warnings and precautions for use 
 
Complex behaviours such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a 
sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedativehypnotics. 
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced 
persons. Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at 
therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with 
sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum 
recommended dose. Due to the risk to the patient and the community, discontinuation of zaleplon is 
recommended for patients who report a “sleep-driving” episode. Other complex behaviours (e.g., 
preparing and eating food, making phone calls, or having sex) have been reported in patients who are 
not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not 
remember these events. 
 
Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, 
including zaleplon. Cases of angioedema involving the tongue, glottis or larynx have been reported in 
patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. Some 
patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or 
nausea and vomiting. Some patients have required medical therapy in the emergency department. If 
angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients 
who develop angioedema after treatment with zaleplon should not be rechallenged with the active 
substance. 
 
Insomnia may represent an underlying physical or psychiatric disorder. Insomnia that persists or 
worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient. 
 
Due to zaleplon’s short plasma half-life, alternative therapy should be considered if early morning 
awakening is experienced. Patients should be advised not to take a second dose within a single night. 
 
Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to 
result in changes in zaleplon’s plasma concentrations. (See section 4.5). 
 
Concomitant intake with alcohol is not recommended. The sedative effect may be enhanced when the 
product is used in combination with alcohol which may affect the ability to drive or use machines the 
next day (see section 4.7). 
 
Tolerance 
Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like 
agents may develop after repeated use for a few weeks. 
 

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Dependence 
Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence. 
The risk of dependence increases with dose and duration of treatment and is greater with patients 
having a history of alcohol and medicinal product abuse. Once physical dependence has developed, 
abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of 
headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe 
cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and 
tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or 
epileptic seizures. There have been post-marketing reports of dependence associated with zaleplon, 
predominantly in combination with other psychotropic agents. 
 
Rebound insomnia and anxiety 
A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or 
benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment. It may 
be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and 
restlessness. 
 
Duration of treatment 
The duration of treatment should be as short as possible (see section 4.2), and should not exceed two 
weeks. Extension beyond these periods should not take place without clinical re-evaluation of the 
patient. 
 
It may be useful to inform the patient when treatment is started that it will be of limited duration. It is 
important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety 
should such symptoms develop when the medicinal product is discontinued. 
 
Memory and psychomotor impairment 
Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor 
impairment. These occur most often up to several hours after ingesting the product. To reduce the risk, 
patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more 
after taking Sonata (see section 4.7). 
 
Psychiatric and “paradoxical” reactions 
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal 
thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate 
behaviour, extroversion that seems out of character and other behavioural effects are known to occur 
when using benzodiazepines or benzodiazepine-like agents. They may be active substance-induced, 
spontaneous in origin, or a result of an underlying psychiatric or physical disorder. These reactions are 
more likely to occur in the elderly. Should this occur, use of this product should be discontinued. Any 
new behavioural sign or symptom requires careful and immediate evaluation. 
 
Specific patient groups 
 
Alcohol and medicinal product abuse 
Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a 
history of alcohol or medicinal product abuse. 
 
Hepatic impairment 
Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic 
insufficiency as they may precipitate encephalopathy (see section 4.2). In patients with mild to 
moderate hepatic insufficiency, the bioavailability of zaleplon is increased because of reduced 
clearance, and the dose will therefore need to be modified in these patients. 
 

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Renal impairment 
Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately 
studied in those patients. In patients with mild to moderate renal impairment, the pharmacokinetic 
profile of zaleplon is not significantly different than that in healthy subjects. Hence, no dose 
adjustment is required in these patients. 
 
Respiratory insufficiency 
Caution should be observed when prescribing sedative medicinal products to patients with chronic 
respiratory insufficiency. 
 
Psychosis 
Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of 
psychotic illness. 
 
Depression 
Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or 
anxiety associated with depression (suicide may be precipitated in such patients). Also, because of the 
increased risk for intentional overdose in patients with depression in general, the quantity of a 
medicinal product, including zaleplon, prescribed for such patients should be kept to the necessary 
minimum. 
 
Sonata contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp 
lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant intake with alcohol is not recommended. The sedative effect may be enhanced when the 
product is used in combination with alcohol which may affect the ability to drive or use machines the 
next day (see section 4.7). 
 
Combination with other CNS-acting compounds should be taken into account. Enhancement of the 
central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, 
anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, 
anaesthetics, and sedative antihistamines. Concomitant use of zaleplon with these drugs may increase 
the risk of next day drowsiness, including impaired driving ability (see section 4.7). 
 
Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg 
daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor 
performance (digit symbol substitution test). Additionally, there was no pharmacokinetic interaction 
between zaleplon and venlafaxine (extended release). 
 
In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in 
physiological dependence. 
 
Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory 
effects in human liver are not known. There is no pharmacokinetic interaction between zaleplon and 
diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of 
each drug. However, because both of these compounds have CNS effects, an additive 
pharmacodynamic effect is possible. 
 
Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde 
oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it 
inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for 
zaleplon’s metabolism. Therefore, caution is advisable in co-administering cimetidine and Sonata. 
 

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Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 
inhibitor, produced a 34% increase in zaleplon’s plasma concentrations. A routine dosage adjustment 
of Sonata is not considered necessary, but patients should be advised that the sedative effects might be 
enhanced. 
 
In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a 
four fold reduction in zaleplon plasma concentration. Co-administration of Sonata together with 
inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction 
of zaleplon’s efficacy. 
 
Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two 
compounds with a narrow therapeutic index. In addition, ibuprofen, as an example of compounds that 
alter renal excretion, showed no interaction with Sonata. 
 
4.6 Fertility, pregnancy and lactation 
 
Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data 
are available on Sonata to assess its safety during pregnancy and breastfeeding. Use of Sonata is not 
recommended during pregnancy. If the medicinal product is prescribed to a woman of child-bearing 
potential, she should be warned to contact her physician regarding discontinuance of the medicinal 
product if she intends to become or suspects that she is pregnant. 
 
If for compelling medical reasons, the medicinal product is administered during the late phase of 
pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and 
moderate respiratory depression, can be expected, due to the pharmacological action of the compound. 
 
Infants born to mothers who took benzodiazepine and benzodiazepine-like agents chronically during 
the latter stages of pregnancy may have developed physical dependence and may be at some risk for 
developing withdrawal symptoms in the postnatal period. 
 
Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding 
mothers. 
 
4.7 Effects on ability to drive and use machines 
 
Sonata has major influence on the ability to drive and use machines. 
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the 
ability to drive or to use machines the next day. If insufficient sleep duration occurs, the likelihood of 
impaired alertness may be increased. Furthermore, the co-administration of zaleplon with alcohol and 
other CNS depressants increases this risk (see section 4.5). Caution is recommended for patients 
performing skilled tasks. Patients should be advised not to drive or operate machinery until it is 
established that their performance is not impaired. 
 
4.8 Undesirable effects 
 
The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and 
dysmenorrhea. 
 
Frequencies are defined as 
Very common (1/10) 
Common (1/100 to <1/10) 
Uncommon (1/1,000 to <1/100) 
Rare (1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
not known (cannot be estimated from the available data) 
 

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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Organ/System 
(Frequency) 

Adverse Reactions 
 

  
Nervous system disorders 
Common: 
Uncommon: 
 

 
amnesia, paraesthesia, somnolence 
ataxia/coordination abnormal, dizziness, 
disturbance in attention, parosmia, speech 
disorder (dysarthria, slurred speech), 
hypoaesthesia 

See also below under Amnesia 
 
Eye disorders 
Uncommon: 
 

 
visual impairment, diplopia 

Ear and labyrinth disorders 
Uncommon: 

 
hyperacusis 
 

Gastrointestinal disorders 
Uncommon: 

 
nausea 
 

Skin and subcutaneous tissue disorders 
Uncommon: 
Frequency not known: 

 
photosensitivity reaction 
angioedema 
 

Metabolism and nutrition disorders 
Uncommon: 
 

 
anorexia 

General disorders and administration site conditions 
Uncommon: 
 

 
asthenia, malaise 

Immune system disorders 
Very rare: 
 

 
anaphylactic/anaphylactoid reactions 

Hepatobiliary disorders 
Frequency not known: 
 

 
hepatotoxicity (mostly described as 
transaminase increased) 
 

Reproductive system and breast disorders 
Common: 

 
dysmenorrhea 
 

Psychiatric disorders 
Uncommon: 
 
Frequency not known: 

 
depersonalisation, hallucinations, depression, 
confusional state, apathy 
somnambulism 
 

See also below under Depression and Psychiatric and “paradoxical” reactions 
 
Amnesia 
Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher 
dosages. Amnestic effects may be associated with inappropriate behaviour (see section 4.4). 
 
Depression 
Pre-existing depression may be unmasked during benzodiazepine or benzodiazepine-like agent use.  
 

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Psychiatric and “paradoxical” reactions 
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal 
thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate 
behaviour, extroversion that seems out of character, and other adverse behavioural reactions are 
known to occur when using benzodiazepines or benzodiazepine-like agents. Such reactions are more 
likely to occur in the elderly. 
 
Dependence 
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation 
of therapy may result in withdrawal or rebound phenomena (see section 4.4). Psychic dependence may 
occur. Abuse of benzodiazepines and benzodiazepine-like active substances has been reported. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose 
levels in humans have not been determined. 
 
As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to 
life unless combined with other CNS depressants (including alcohol). 
 
Symptoms of overdose 
Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central 
nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include 
drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, 
hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. Chromaturia (blue-
green urine discolouration) has been reported with zaleplon overdose. 
 
Therapy of overdose  
In the management of overdose with any medicinal product, it should be borne in mind that multiple 
agents may have been taken. 
 
Treatment of Sonata overdose is largely supportive. Attention to airway patency and supportive 
management of ventilation and haemodynamics are usually sufficient. In mild cases patients should 
sleep under control of respiratory and circulatory function. Induced vomiting is not recommended. In 
severe cases, use of activated charcoal or gastric lavage may be useful when performed soon after 
ingestion. Further, stabilization of circulatory function and intensive monitoring may be required. The 
value of forced dialysis or haemodialysis in the treatment of over dosage has not been determined. 
 
Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the 
management of Sonata overdose. However, there is no clinical experience with the use of flumazenil 
as an antidote to a Sonata overdose. 
 
 

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5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03 
 
Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and 
other hypnotics. Zaleplon binds selectively to the benzodiazepine type I receptor. 
 
Zaleplon’s pharmacokinetic profile shows rapid absorption and elimination (see section 5.2). In 
combination with its subtype selective receptor-binding characteristics, with high selectivity and low 
affinity for the benzodiazepine type I receptor, these properties are responsible for the overall 
characteristics of Sonata. 
 
Sonata’s efficacy has been demonstrated in both sleep laboratory studies using objective 
polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to 
assess sleep. In these studies, patients were diagnosed with primary (psychophysiological) insomnia. 
 
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 
10 mg. In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was 
consistently decreased with Sonata 10 mg compared with placebo in 2-week studies. This decreased 
sleep latency was significantly different from that observed with placebo. Results from the 2- and 4-
week studies showed that no pharmacological tolerance developed with any dose of Sonata. 
 
In Sonata studies using objective PSG measures, Sonata 10 mg was superior to placebo in decreasing 
sleep latency and increasing sleep duration during the first half of the night. Sonata has been shown to 
preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each 
sleep stage. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations 
are reached in approximately 1 hour. At least 71% of the orally-administered dose is absorbed. 
Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately 
30%. 
 
Distribution 
Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous 
administration. The in vitro plasma protein binding is approximately 60%, suggesting little risk of 
active substance interaction due to protein binding. 
 
Metabolism 
Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon. Additionally, zaleplon 
is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase 
to form 5-oxo-desethylzaleplon. The oxidative metabolites are further metabolised by conjugation via 
glucuronidation. All of zaleplon’s metabolites are inactive in both animal behavioural models and in 
vitro activity assays. 
 
Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of 
accumulation following administration of up to 30 mg/day. The elimination half-life of zaleplon is 
approximately 1 hour. 

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Excretion 
Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%). 
Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its 
glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide 
metabolite. The remainder of the urinary recovery consists of minor metabolites. The majority of the 
faecal recovery consists of 5-oxo-zaleplon. 
 
Hepatic Impairment 
Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism. 
Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and 
decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up 
to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy 
subjects. The dose of zaleplon should be reduced in patients with mild to moderate hepatic 
impairment, and zaleplon is not recommended for use in patients with severe hepatic impairment. 
 
Renal Impairment 
The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 
40 to 89 ml/min) and moderate (20 to 39 ml/min)   renal impairment, and in patients on dialysis. In 
patients with moderate impairment and those on dialysis there was a reduction of approximately 23% 
in peak plasma concentration compared to healthy volunteers. The extent of exposure to zaleplon was 
similar among all groups. Therefore, no dose adjustment is necessary in patients with mild to moderate 
renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment. 
 
5.3 Preclinical safety data 
 
Repeated dose toxicity 
In line with effects observed with other compounds binding to benzodiazepine receptors, reversible 
increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral 
administration of high multiples of the maximum human therapeutic dose. At these doses, a significant 
reduction in the weight of both prostate and testes was apparent in a three month study in prepubescent 
dogs. 
 
Reproduction toxicity 
In a fertility and reproductive performance study in rats, mortality and decreased fertility were 
observed in males and females at an oral zaleplon dose of 100 mg/kg/day (equivalent to 49-times the 
maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis). Follow-up studies 
indicated that impaired fertility was due to an effect on the female. 
 
In embryofetal development studies, oral administration of zaleplon up to 100 mg/kg/day and 50 
mg/kg/day to pregnant rats and rabbits, respectively, produced no evidence of teratogenicity 
(equivalent to 49- (rat) and 48-(rabbit) times the MRHD on a mg/m2 basis). Pre-and postnatal growth 
of rats was reduced at the maternally toxic dose of 100 mg/kg/day. The no-effect dose for growth of 
rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis). No adverse effects on 
embryofetal development were observed in rabbits. 
 
In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and 
decreased growth and physical development, were observed in the offspring of females treated with 
doses of ≥7 mg/kg/day that did not elicit maternal toxicity. The no-effect dose for postnatal 
development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis). In a subsequent 
cross-fostering study, adverse effects on offspring viability and growth appeared to result from both in 
utero and lactational exposure to zaleplon. 
 

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Carcinogenicity 
Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day 
did not result in compound-related tumorigenicity. Oral administration of zaleplon to mice for 65 or 
104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant 
increase in benign but not in malignant liver tumors. The increased incidence of benign liver tumors in 
mice was likely an adaptive event. 
 
Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of 
Sonata at recommended doses in humans.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule core 
Microcrystalline cellulose,  
pregelatinised starch,  
silicon dioxide,  
sodium lauryl sulphate,  
magnesium stearate,  
lactose monohydrate,  
indigo carmine (E132),  
titanium dioxide (E171). 
 
Capsule shell 
gelatin,  
titanium dioxide (E171),  
red iron oxide (E172),  
yellow iron oxide (E172),  
black iron oxide (E172),  
sodium lauryl sulphate,  
 
Printing inks on the shell contain the following (gold ink SB-3002):  
shellac,  
ammonium hydroxide,  
yellow iron oxide (E172). 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life  
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
 
6.5 Nature and contents of container 
 
PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters. Not all 
pack sizes may be marketed. 
 

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6.6  Special precautions for disposal and other handling 
 
No special requirements. 
 
Sonata has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will 
change colour and become cloudy. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Meda AB 
Pipers väg 2A 
S-170 09 Solna  
Sweden 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/99/102/001-003 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 March 1999 
Date of latest renewal: 12 March 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Sonata 10 mg hard capsules 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each capsule contains 10 mg of zaleplon. 
 
Excipient with known effect: Lactose monohydrate 49 mg. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Capsule, hard. 
Capsules have an opaque white hard shell with the strength “10 mg”. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
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. 
 
4.2 Posology and method of administration 
 
For adults, the recommended dose is 10 mg.  
 
Treatment should be as short as possible with a maximum duration of two weeks. 
 
Sonata can be taken immediately before going to bed or after the patient has gone to bed and is 
experiencing difficulty falling asleep. As administration after food delays the time to maximal plasma 
concentration by approximately 2 hours no food should be eaten with or shortly before intake of 
Sonata. 
 
The total daily dose of Sonata should not exceed 10 mg in any patient. Patients should be advised not 
to take a second dose within a single night. 
 
Elderly 
Elderly patients may be sensitive to the effects of hypnotics; therefore, 5 mg is the recommended dose 
of Sonata. 
 
Paediatric patients 
Sonata is contraindicated in children and adolescents under 18 years of age (see section 4.3). 
 
Hepatic impairment 
As clearance is reduced, patients with mild to moderate hepatic impairment should be treated with 
Sonata 5 mg. For severe hepatic impairment see section 4.3. 
 

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Renal impairment 
No dosage adjustment is required in patients with mild to moderate renal insufficiency, because Sonata 
pharmacokinetics is not altered in such patients. Severe renal impairment is contraindicated (see 
section 4.3.). 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Severe hepatic impairment 
Severe renal impairment 
Sleep apnoea syndrome 
Myasthenia gravis 
Severe respiratory insufficiency 
Children and adolescents (under 18 years of age) 
 
4.4 Special warnings and precautions for use 
 
Complex behaviours such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a 
sedative-hypnotic, with amnesia for the event) have been reported in patients taking sedativehypnotics. 
These events can occur in sedative-hypnotic-naive as well as in sedative-hypnotic experienced 
persons. Although behaviours such as sleep-driving may occur with a sedative-hypnotic alone at 
therapeutic doses, the use of alcohol and other central nervous system (CNS) depressants with 
sedative-hypnotics appears to increase the risk of such behaviours, as does exceeding the maximum 
recommended dose. Due to the risk to the patient and the community, discontinuation of zaleplon is 
recommended for patients who report a “sleep-driving” episode. Other complex behaviours (e.g., 
preparing and eating food, making phone calls, or having sex) have been reported in patients who are 
not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not 
remember these events. 
 
Severe anaphylactic/anaphylactoid reactions have been reported with the use of sedative-hypnotics, 
including zaleplon. Cases of angioedema involving the tongue, glottis or larynx have been reported in 
patients after taking the first or subsequent doses of sedative-hypnotics, including zaleplon. Some 
patients taking sedative-hypnotics have had additional symptoms such as dyspnoea, throat closing, or 
nausea and vomiting. Some patients have required medical therapy in the emergency department. If 
angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients 
who develop angioedema after treatment with zaleplon should not be rechallenged with the active 
substance. 
 
Insomnia may represent an underlying physical or psychiatric disorder. Insomnia that persists or 
worsens after a short course of zaleplon treatment may indicate a need to re-evaluate the patient. 
 
Due to zaleplon’s short plasma half-life, alternative therapy should be considered if early morning 
awakening is experienced. Patients should be advised not to take a second dose within a single night. 
 
Co-administration of Sonata with medicinal products known to influence CYP3A4 is expected to 
result in changes in zaleplon’s plasma concentrations. (See section 4.5). 
 
Concomitant intake with alcohol is not recommended. The sedative effect may be enhanced when the 
product is used in combination with alcohol which may affect the ability to drive or use machines the 
next day (see section 4.7). 
 
Tolerance 
Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines and benzodiazepine-like 
agents may develop after repeated use for a few weeks. 
 

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Dependence 
Use of benzodiazepines and benzodiazepine-like agents may lead to physical and psychic dependence. 
The risk of dependence increases with dose and duration of treatment and is greater with patients 
having a history of alcohol and medicinal product abuse. Once physical dependence has developed, 
abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of 
headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe 
cases the following symptoms may occur: unreality, depersonalisation, hyperacusis, numbness and 
tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or 
epileptic seizures. There have been post-marketing reports of dependence associated with zaleplon, 
predominantly in combination with other psychotropic agents. 
 
Rebound insomnia and anxiety 
A transient syndrome whereby the symptoms that led to the treatment with a benzodiazepine or 
benzodiazepine-like agent recur in an enhanced form, may occur on withdrawal of treatment. It may 
be accompanied by other reactions including mood changes, anxiety, or sleep disturbances and 
restlessness.  
 
Duration of treatment 
The duration of treatment should be as short as possible (see section 4.2), and should not exceed two 
weeks. Extension beyond these periods should not take place without clinical re-evaluation of the 
patient. 
 
It may be useful to inform the patient when treatment is started that it will be of limited duration.  It is 
important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety 
should such symptoms develop when the medicinal product is discontinued. 
 
Memory and psychomotor impairment 
Benzodiazepines and benzodiazepine-like agents may induce anterograde amnesia and psychomotor 
impairment. These occur most often up to several hours after ingesting the product. To reduce the risk, 
patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more 
after taking Sonata (see section 4.7). 
 
Psychiatric and “paradoxical” reactions 
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal 
thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate 
behaviour, extroversion that seems out of character and other behavioural effects are known to occur 
when using benzodiazepines or benzodiazepine-like agents. They may be active substance-induced, 
spontaneous in origin, or a result of an underlying psychiatric or physical disorder. These reactions are 
more likely to occur in the elderly. Should this occur, use of this product should be discontinued. Any 
new behavioural sign or symptom requires careful and immediate evaluation. 
 
Specific patient groups 
 
Alcohol and medicinal product abuse 
Benzodiazepine and benzodiazepine-like agents should be used with extreme caution in patients with a 
history of alcohol or medicinal product abuse. 
 
Hepatic impairment 
Benzodiazepine and benzodiazepine-like agents are not indicated to treat patients with severe hepatic 
insufficiency as they may precipitate encephalopathy (see section 4.2). In patients with mild to 
moderate hepatic insufficiency, the bioavailability of zaleplon is increased because of reduced 
clearance, and the dose will therefore need to be modified in these patients. 
 

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Renal impairment 
Sonata is not indicated to treat patients with severe renal impairment as it has not been adequately 
studied in those patients. In patients with mild to moderate renal impairment, the pharmacokinetic 
profile of zaleplon is not significantly different than that in healthy subjects. Hence, no dose 
adjustment is required in these patients. 
 
Respiratory insufficiency 
Caution should be observed when prescribing sedative medicinal products to patients with chronic 
respiratory insufficiency. 
 
Psychosis 
Benzodiazepine and benzodiazepine-like agents are not recommended for the primary treatment of 
psychotic illness. 
 
Depression 
Benzodiazepines and benzodiazepine-like agents should not be used alone to treat depression or 
anxiety associated with depression (suicide may be precipitated in such patients). Also, because of the 
increased risk for intentional overdose in patients with depression in general, the quantity of a 
medicinal product, including zaleplon, prescribed for such patients should be kept to the necessary 
minimum. 
 
Sonata contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp 
lactase deficiency or glucose-galactose malabsorption should not take this medicine. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Concomitant intake with alcohol is not recommended. The sedative effect may be enhanced when the 
product is used in combination with alcohol which may affect the ability to drive or use machines the 
next day (see section 4.7). 
 
Combination with other CNS-acting compounds should be taken into account. Enhancement of the 
central sedation may occur in cases of concomitant use with antipsychotics (neuroleptics), hypnotics, 
anxiolytics/sedatives, antidepressant agents, narcotic analgesics, anti-epileptic medicinal products, 
anaesthetics, and sedative antihistamines. Concomitant use of zaleplon with these drugs may increase 
the risk of next day drowsiness, including impaired driving ability (see section 4.7). 
 
Coadministration of a single zaleplon 10 mg dose and venlafaxine (extended release) 75 mg or 150 mg 
daily did not produce any interaction on memory (immediate and delayed word recall) or psychomotor 
performance (digit symbol substitution test). Additionally, there was no pharmacokinetic interaction 
between zaleplon and venlafaxine (extended release). 
 
In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in 
physiological dependence. 
 
Diphenhydramine is reported to be a weak inhibitor of aldehyde oxidase in rat liver, but its inhibitory 
effects in human liver are not known. There is no pharmacokinetic interaction between zaleplon and 
diphenhydramine following the administration of a single dose (10 mg and 50 mg, respectively) of 
each drug. However, because both of these compounds have CNS effects, an additive 
pharmacodynamic effect is possible. 
 
Cimetidine, a non-specific moderate inhibitor of several hepatic enzymes including both aldehyde 
oxidase and CYP3A4, produced an 85% increase in plasma concentrations of zaleplon because it 
inhibited both the primary (aldehyde oxidase) and secondary (CYP3A4) enzymes responsible for 
zaleplon’s metabolism. Therefore, caution is advisable in co-administering cimetidine and Sonata.  
 

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Co-administration of Sonata with a single 800 mg dose of erythromycin, a strong, selective CYP3A4 
inhibitor, produced a 34% increase in zaleplon’s plasma concentrations. A routine dosage adjustment 
of Sonata is not considered necessary, but patients should be advised that the sedative effects might be 
enhanced. 
 
In contrast, rifampicin, a strong inducer of several hepatic enzymes, including CYP3A4 resulted in a 
four fold reduction in zaleplon plasma concentration. Co-administration of Sonata together with 
inducers of CYP3A4 such as rifampicin, carbamazepine and phenobarbitone, may result in a reduction 
of zaleplon’s efficacy. 
 
Sonata did not affect the pharmacokinetic and pharmacodynamic profiles of digoxin and warfarin, two 
compounds with a narrow therapeutic index. In addition, ibuprofen, as an example of compounds that 
alter renal excretion, showed no interaction with Sonata. 
 
4.6 Fertility, pregnancy and lactation 
 
Although animal studies have shown no teratogenic or embryotoxic effects, insufficient clinical data 
are available on Sonata to assess its safety during pregnancy and breastfeeding. Use of Sonata is not 
recommended during pregnancy. If the medicinal product is prescribed to a woman of child-bearing 
potential, she should be warned to contact her physician regarding discontinuance of the medicinal 
product if she intends to become or suspects that she is pregnant. 
 
If for compelling medical reasons, the medicinal product is administered during the late phase of 
pregnancy, or during labour at high doses, effects on the neonate, such as hypothermia, hypotonia and 
moderate respiratory depression, can be expected, due to the pharmacological action of the compound. 
 
Infants born to mothers who took benzodiazepine and benzodiazepine-like agents chronically during 
the latter stages of pregnancy may have developed physical dependence and may be at some risk for 
developing withdrawal symptoms in the postnatal period. 
 
Because zaleplon is excreted in the breast milk, Sonata should not be administered to breast-feeding 
mothers. 
 
4.7 Effects on ability to drive and use machines 
 
Sonata has major influence on the ability to drive and use machines. 
Sedation, amnesia, impaired concentration and impaired muscular function may adversely affect the 
ability to drive or to use machines the next day. If insufficient sleep duration occurs, the likelihood of 
impaired alertness may be increased. Furthermore, the co-administration of zaleplon with alcohol and 
other CNS depressants increases this risk (see section 4.5). Caution is recommended for patients 
performing skilled tasks. Patients should be advised not to drive or operate machinery until it is 
established that their performance is not impaired. 
 
4.8 Undesirable effects 
 
The most frequent reported adverse drug reactions are amnesia, paraesthesia, somnolence and 
dysmenorrhea. 
 
Frequencies are defined as 
Very common (1/10) 
Common (1/100 to <1/10) 
Uncommon (1/1,000 to <1/100) 
Rare (1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
not known (cannot be estimated from the available data) 
 

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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
Organ/System  
(Frequency) 

Adverse Reactions 
 

  
Nervous system disorders 
Common: 
Uncommon: 
 

 
amnesia, paraesthesia, somnolence 
ataxia/coordination abnormal, dizziness, 
disturbance in attention, parosmia, speech 
disorder (dysarthria, slurred speech), 
hypoaesthesia 

See also below under Amnesia 
 
Eye disorders 
Uncommon:  
 

 
visual impairment, diplopia 

Ear and labyrinth disorders 
Uncommon: 

 
hyperacusis 
 

Gastrointestinal disorders 
Uncommon: 

 
nausea 
 

Skin and subcutaneous tissue disorders 
Uncommon: 
Frequency not known: 

 
photosensitivity reaction 
angioedema 
 

Metabolism and nutrition disorders 
Uncommon: 
 

 
anorexia 

General disorders and administration site conditions 
Uncommon: 
 

 
asthenia, malaise 

Immune system disorders 
Very rare: 
 

 
anaphylactic/anaphylactoid reactions 

Hepatobiliary disorders 
Frequency not known: 
 

 
hepatotoxicity (mostly described as 
transaminase increased) 
 

Reproductive system and breast disorders 
Common: 

 
dysmenorrhea 
 

Psychiatric disorders 
Uncommon: 
 
Frequency not known: 

 
depersonalisation, hallucinations, depression, 
confusional state, apathy 
somnambulism 
 

See also below under Depression and Psychiatric and “paradoxical” reactions 
 
Amnesia 
Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher 
dosages. Amnestic effects may be associated with inappropriate behaviour (see section 4.4). 
 
Depression 
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Psychiatric and “paradoxical” reactions 
Reactions like restlessness, agitation, irritability, decreased inhibition, aggressiveness, abnormal 
thinking, delusions, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate 
behaviour, extroversion that seems out of character and other adverse behavioural reactions are known 
to occur when using benzodiazepines or benzodiazepine-like agents. Such reactions are more likely to 
occur in the elderly. 
 
Dependence 
Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation 
of therapy may result in withdrawal or rebound phenomena (see section 4.4). Psychic dependence may 
occur. Abuse of benzodiazepines and benzodiazepine-like active substances has been reported. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
There is limited clinical experience with the effects of an acute overdose of Sonata, and overdose 
levels in humans have not been determined. 
 
As with other benzodiazepines or benzodiazepine-like agents, overdose should not present a threat to 
life unless combined with other CNS depressants (including alcohol). 
 
Symptoms of overdose 
Overdose of benzodiazepine or benzodiazepine-like agents is usually manifested by degrees of central 
nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include 
drowsiness, mental confusion, and lethargy, in more serious cases, symptoms may include ataxia, 
hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. Chromaturia (blue-
green urine discolouration) has been reported with zaleplon overdose. 
 
Therapy of overdose  
In the management of overdose with any medicinal product, it should be borne in mind that multiple 
agents may have been taken. 
 
Treatment of Sonata overdose is largely supportive. Attention to airway patency and supportive 
management of ventilation and haemodynamics are usually sufficient. In mild cases patients should 
sleep under control of respiratory and circulatory function. Induced vomiting is not recommended. In 
severe cases, use of activated charcoal or gastric lavage may be useful when performed soon after 
ingestion. Further, stabilization of circulatory function and intensive monitoring may be required. The 
value of forced dialysis or haemodialysis in the treatment of over dosage has not been determined. 
 
Animal studies suggest that flumazenil is an antagonist to zaleplon and should be considered in the 
management of Sonata overdose. However, there is no clinical experience with the use of flumazenil 
as an antidote to a Sonata overdose. 
 
 

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5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03 
 
Zaleplon is a pyrazolopyrimidine hypnotic that is structurally different from benzodiazepines and 
other hypnotics. Zaleplon binds selectively to the benzodiazepine type I receptor. 
 
Zaleplon’s pharmacokinetic profile shows rapid absorption and elimination (see section 5.2). In 
combination with its subtype selective receptor-binding characteristics, with high selectivity and low 
affinity for the benzodiazepine type I receptor, these properties are responsible for the overall 
characteristics of Sonata. 
 
Sonata’s efficacy has been demonstrated in both sleep laboratory studies using objective 
polysomnography (PSG) measures of sleep and in outpatient studies using patient questionnaires to 
assess sleep. In these studies, patients were diagnosed with primary (psychophysiological) insomnia. 
 
Sleep latency in outpatient studies was decreased for up to 4 weeks in non-elderly patients with Sonata 
10 mg. In elderly patients, sleep latency was often significantly decreased with Sonata 5 mg and was 
consistently decreased with Sonata 10 mg compared with placebo in 2-week studies. This decreased 
sleep latency was significantly different from that observed with placebo. Results from the 2- and 4-
week studies showed that no pharmacological tolerance developed with any dose of Sonata. 
 
In Sonata studies using objective PSG measures, Sonata 10 mg was superior to placebo in decreasing 
sleep latency and increasing sleep duration during the first half of the night. Sonata has been shown to 
preserve sleep stages in controlled studies that measured the percentage of sleep time spent in each 
sleep stage. 
 
5.2 Pharmacokinetic properties 
 
Absorption 
Zaleplon is rapidly and almost completely absorbed after oral administration, and peak concentrations 
are reached in approximately 1 hour. At least 71% of the orally-administered dose is absorbed. 
Zaleplon undergoes presystemic metabolism, resulting in an absolute bioavailability of approximately 
30%. 
 
Distribution 
Zaleplon is lipophilic with a volume of distribution of about 1.4 ± 0.3 l/kg following intravenous 
administration. The in vitro plasma protein binding is approximately 60%, suggesting little risk of 
active substance interaction due to protein binding. 
 
Metabolism 
Zaleplon is primarily metabolised by aldehyde oxidase to form 5-oxo-zaleplon. Additionally, zaleplon 
is metabolised by CYP3A4 to form desethylzaleplon which is further metabolised by aldehyde oxidase 
to form 5-oxo-desethylzaleplon. The oxidative metabolites are further metabolised by conjugation via 
glucuronidation. All of zaleplon’s metabolites are inactive in both animal behavioural models and in 
vitro activity assays. 
 
Zaleplon plasma concentrations increased linearly with dose, and zaleplon showed no signs of 
accumulation following administration of up to 30 mg/day. The elimination half-life of zaleplon is 
approximately 1 hour. 
 

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Excretion 
Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%). 
Fifty-seven percent (57%) of the dose is recovered in urine in the form of 5-oxo-zaleplon and its 
glucuronide metabolite, an additional 9% is recovered as 5-oxo-desethylzaleplon and its glucuronide 
metabolite. The remainder of the urinary recovery consists of minor metabolites. The majority of the 
faecal recovery consists of 5-oxo-zaleplon. 
 
Hepatic Impairment 
Zaleplon is metabolised primarily by the liver and undergoes significant presystemic metabolism. 
Consequently, the oral clearance of zaleplon was reduced by 70% and 87% in compensated and 
decompensated cirrhotic patients, respectively, leading to marked increases in mean Cmax and AUC (up 
to 4-fold and 7-fold in compensated and decompensated patients, respectively) relative to healthy 
subjects. The dose of zaleplon should be reduced in patients with mild to moderate hepatic 
impairment, and zaleplon is not recommended for use in patients with severe hepatic impairment. 
 
Renal Impairment 
The single dose pharmacokinetics of zaleplon were studied in patients with mild (creatinine clearance 
40 to 89 ml/min) and moderate (20 to 39 ml/min)   renal impairment, and in patients on dialysis. In 
patients with moderate impairment and those on dialysis there was a reduction of approximately 23% 
in peak plasma concentration compared to healthy volunteers. The extent of exposure to zaleplon was 
similar among all groups. Therefore, no dose adjustment is necessary in patients with mild to moderate 
renal impairment. Zaleplon has not been adequately studied in patients with severe renal impairment. 
 
5.3 Preclinical safety data 
 
Repeated dose toxicity 
In line with effects observed with other compounds binding to benzodiazepine receptors, reversible 
increases in liver and adrenal weights in rats and dogs were only noted upon repeated oral 
administration of high multiples of the maximum human therapeutic dose. At these doses, a significant 
reduction in the weight of both prostate and testes was apparent in a three month study in prepubescent 
dogs. 
 
Reproduction toxicity 
In a fertility and reproductive performance study in rats, mortality and decreased fertility were 
observed in males and females at an oral zaleplon dose of 100 mg/kg/day (equivalent to 49-times the 
maximum recommended human dose (MRHD) of 20 mg on a mg/m2 basis). Follow-up studies 
indicated that impaired fertility was due to an effect on the female. 
 
In embryofetal development studies, oral administration of zaleplon up to 100 mg/kg/day and 50 
mg/kg/day to pregnant rats and rabbits, respectively, produced no evidence of teratogenicity 
(equivalent to 49- (rat) and 48-(rabbit) times the MRHD on a mg/m2 basis). Pre-and postnatal growth 
of rats was reduced at the maternally toxic dose of 100 mg/kg/day. The no-effect dose for growth of 
rat offspring was 10 mg/kg (equivalent to 5-times the MRHD on a mg/m2 basis). No adverse effects on 
embryofetal development were observed in rabbits. 
 
In a pre- and postnatal development study in rats, increased stillbirth and postnatal mortality, and 
decreased growth and physical development, were observed in the offspring of females treated with 
doses of ≥7 mg/kg/day that did not elicit maternal toxicity. The no-effect dose for postnatal 
development was 1 mg/kg/day (equivalent to 0.5-times the MRHD on a mg/m2 basis). In a subsequent 
cross-fostering study, adverse effects on offspring viability and growth appeared to result from both in 
utero and lactational exposure to zaleplon. 
 

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Carcinogenicity 
Oral administration of zaleplon to rats for 104 consecutive weeks at dosage levels up to 20 mg/kg/day 
did not result in compound-related tumorigenicity. Oral administration of zaleplon to mice for 65 or 
104 consecutive weeks at high dosage levels (≥100 mg/kg/day) elicited a statistically significant 
increase in benign but not in malignant liver tumors. The increased incidence of benign liver tumors in 
mice was likely an adaptive event. 
 
Overall, the results of the preclinical studies do not suggest any significant safety hazard for use of 
Sonata at recommended doses in humans.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Capsule core 
Microcrystalline cellulose,  
pregelatinised starch,  
silicon dioxide,  
sodium lauryl sulphate,  
magnesium stearate,  
lactose monohydrate,  
indigo carmine (E132),  
titanium dioxide (E171).   
 
Capsule shell 
gelatin,  
titanium dioxide (E171), 
sodium lauryl sulphate,  
 
Printing inks on the shell contain the following (pink ink SW-1105):  
shellac,  
titanium dioxide (E171),  
ammonium hydroxide,  
red iron oxide (E172),  
yellow iron oxide (E172). 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life  
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special temperature storage conditions. 
 
6.5 Nature and contents of container 
 
PVC / PVDC aluminium blister packages of 7, 10, 14 capsules in perforated unit-dose blisters. Not all 
pack sizes may be marketed. 
 

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6.6  Special precautions for disposal and other handling 
 
No special requirements. 
 
Sonata has been designed so that if the contents of the capsule are dissolved in a liquid, the liquid will 
change colour and become cloudy. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Meda AB 
Pipers väg 2A 
S-170 09 Solna  
Sweden 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/99/102/004-006 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 12 March 1999 
Date of latest renewal: 12 March 2009 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 
 

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ANNEX II 
 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 

SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 
 
 

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A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
MEDA Manufacturing GmbH 
Neurather Ring 1 
51063 Cologne 
Germany 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
Periodic Safety Update Reports 
The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE 
USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
 

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ANNEX III 
LABELLING AND PACKAGE LEAFLET 

 

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A. LABELLING 
 
 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR 
SONATA 5 MG – PACK SIZES 7, 10 AND 14 CAPSULES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sonata 5 mg hard capsules 
zaleplon 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 5 mg zaleplon 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose monohydrate 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 hard capsules 
10 hard capsules 
14 hard capsules  
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Meda AB 
Pipers väg 2A 
S-170 09 Solna  
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/102/001 7 capsules  
EU/1/99/102/002 10 capsules 
EU/1/99/102/003 14 capsules 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
Sonata 5 mg  
 
 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
5 MG CAPSULE BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sonata 5 mg hard capsules 
zaleplon 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Meda AB 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON, TEXT FOR 
SONATA 10 MG – PACK SIZES 7, 10 AND 14 CAPSULES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sonata 10 mg hard capsules 
zaleplon 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each hard capsule contains 10 mg zaleplon 
 
 
3. LIST OF EXCIPIENTS 
 
Also contains: lactose monohydrate 
See leaflet for further information. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
7 hard capsules 
10 hard capsules 
14 hard capsules 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS
 
 

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10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Meda AB 
Pipers väg 2A 
S-170 09 Solna  
Sweden 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/99/102/004 7 capsules 
EU/1/99/102/005 10 capsules 
EU/1/99/102/006 14 capsules 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE  
 
Sonata 10 mg  
 
 
 
 

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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
10 MG CAPSULE BLISTERS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Sonata 10 mg hard capsules 
zaleplon 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Meda AB 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. OTHER 
 

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B. PACKAGE LEAFLET 
 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Sonata 5 mg hard capsules 
zaleplon 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 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 signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Sonata is and what it is used for 
2. What you need to know before you take Sonata 
3. How to take Sonata 
4. Possible side effects 
5. How to store Sonata 
6. Contents of the pack and other information 
 
 
1. What Sonata is and what it is used for 
 
Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which 
consists of preparations with hypnotic actions. 
 
Sonata 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. 
 
 
2. What you need to know before you take Sonata  
 
Do not take Sonata 
 
 if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in 

section 6). 
 if you have sleep apnoea syndrome (stopping breathing for short periods while asleep). 
 if you have severe kidney or liver problems. 
 if you have myasthenia gravis (very weak or tired muscles). 
 if you have severe breathing or chest problems. 
 
If you are in any doubt about whether you have any of these conditions, do ask your doctor. 
Children and adolescents under 18 years of age must not take Sonata. 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking 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 medicines 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. Once physical dependence has 
developed, abrupt termination of treatment may be accompanied by withdrawal symptoms. 

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These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion 
and irritability. 

 Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to. 
 Do not use a second dose of Sonata within a single night. 
 If your sleeplessness persists or worsens after a short course of Sonata treatment contact your 

doctor. 
 There is a chance that you may experience a certain type of temporary memory loss (amnesia) 

and lack of coordination when taking sleep medicines. This can usually be avoided if you 
remain inactive for at least 4 hours after taking Sonata. 

 There is a chance that you may experience somnambulism (sleepwalking), including eating or 
driving while not fully awake with no memory of the event. If you experience these events, 
contact your doctor immediately.  

 Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, 
rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, 
extroversion that seems out of character and other behavioural effects have been reported 
following use of any medicines belonging to the sleep inducing group, including Sonata.  These 
reactions may be active substance-induced, spontaneous in origin, or a result of an underlying 
psychiatric or physical disorder. They are more likely to occur in the elderly. If you experience 
these events, contact your doctor immediately. 

 Rare cases of severe allergic reactions have been reported. An allergic reaction may include a 
rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and 
vomiting. If you experience any of these events, contact your doctor immediately. 

 
Children and adolescents 
Do not give this medicine to children and adolescents under 18 years of age. 
 
Other medicines and Sonata 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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), medicines used for strong pain relief (narcotic 
analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), 
medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of 
allergies (sedative antihistamines). Drinking alcohol while being treated with Sonata may also cause 
you to feel drowsy the next day. Never drink alcohol while you are being treated with Sonata (see 
“Warnings and precautions”). 
 
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or 
erythromycin (an antibiotic). 
 
Sonata with food, drink and alcohol 
 
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 “Warnings and precautions”). 
 

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Pregnancy and breast-feeding 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Sonata should not be taken at these 
times because there are not enough clinical data available to assess its safety during pregnancy and 
breast-feeding. 
 
Driving and using machines 
 
Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness. This 
feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if 
you are already taking another central nervous system depressant or if you are drinking alcohol (see 
‘other medicines and Sonata’). If affected do not drive or operate machinery. 
 
 
Sonata contains lactose. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Sonata 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The usual dose for adults is 10 mg 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. 
 
There are different doses for people who are 65 or older, and those who have mild to moderate liver 
problems: 
 65 or older: Take one 5 mg capsule 
 Mild to moderate liver problems: Take one 5 mg capsule  
 
Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will 
change colour and become cloudy. 
 
If you take more Sonata than you should 
 
Contact a doctor immediately and say how many capsules you have taken. Do not go 
unaccompanied to seek medical help. 
 
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses 
probably leading to a coma. 
 
If you forget to take Sonata 
 
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 medicine, ask your doctor or pharmacist. 

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4. Possible side effects 
 
Like all medicines, this medicine 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. 
 
The frequency of possible side effects listed below is defined using the following convention: 
very common (affects more than 1 user in 10) 
common (affects 1 to 10 users in 100) 
uncommon (affects 1 to 10 users in 1,000) 
rare (affects 1 to 10 users in 10,000) 
very rare (affects less than 1 user in 10,000) 
not known (frequency cannot be estimated from the available data) 
 
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. 
in the extremities (paraesthesia); painful menstruation.  
 
Uncommon side effects include: dizziness; weakness; reduced coordination of movements; 
unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; 
irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, 
decreased inhibition, aggressiveness, 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 
extremities (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. An allergic reaction may also include a rash, 
itching, or swelling of the face, lips, throat or tongue. 
 
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. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Sonata 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date 
refers to the last day of that month. 
 
This medicinal product does not require any special temperature storage conditions. 
 
If you have any further questions, please consult your doctor or pharmacist. 
 

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Sonata contains 
 
The active substance in each Sonata hard capsule is zaleplon 5 mg. 
 
The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium 
lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide 
(E171). 
 
Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron 
oxide (E172), black iron oxide (E172) and sodium lauryl sulphate. Printing inks on the shell contain 
the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172). 
 
What Sonata looks like and contents of the pack 
 
Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, 
with gold imprint “5 mg”. They are packed in blisters. Each pack contains 7, 10 or 14 hard capsules.  
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation holder: 
Meda AB 
Pipers väg 2A 
S-170 73 Solna  
Sweden 
 
 

Manufacturer: 
MEDA Manufacturing GmbH 
Neurather Ring 1 
51063 Cologne 
Germany 
 
 

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
MEDA Pharma S.A./N.V. 
Chaussée de la Hulpe 166/ 
Terhulpsesteenweg 166 
B-1170 Brussels 
Tél/Tel: +32 2 5 04 08 11 
 

Lietuva 
Meda Pharma SIA 
Veiverių 134 
LT – 46352 Kaunas 
Tel.: +370 37 330 509 
 

България 
ТП Меда Фармасойтикалс 
Ул. Одрин 71-75, ет.2, ап 7 
1303 София 
Тел.: +359 2 4177977 
 

Luxembourg/Luxemburg 
MEDA Pharma S.A./N.V. 
Chaussée de la Hulpe 166/ 
Terhulpsesteenweg 166 
B-1170 Brussels 
Belgique/Belgien 
Tél/Tel: +32 2 5 04 08 11 
 

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Česká republika 
MEDA Pharma s.r.o. 
Kodaňská 1441/46 
CZ 100 10 Praha 10 
Tel: +420 234 064 203 
 

Magyarország 
MEDA PHARMA Hungary Kereskedelmi Kft. 
H-1139 Budapest 
Váci ut 91 
Tel.: +36 1 236 3410 
 

Danmark 
Meda A/S 
Solvang 8 
DK-3450 Allerød 
Tlf: +45 44 52 88 88 
 

Malta 
Alfred Gera & Sons Ltd.  
10, Triq il-Masġar 
Qormi QRM 3217 
Tel:  +356 2092 4000 
 

Deutschland 
MEDA Pharma GmbH & Co. KG 
Benzstraße 1 
D-61352 Bad Homburg v.d.H. 
Tel: + 49 6172 888 01 
 

Nederland 
MEDA Pharma B.V. 
Krijgsman 20 
NL-1186 DM Amstelveen 
Tel: +31 20 751 65 00 

Eesti 
Meda Pharma SIA 
Narva mnt 11D  
EE - 10151 Tallinn, Eesti  
Tel. + 372 6261 025 
 

Norge 
Meda A/S 
Askerveien 61 
N-1384 Asker 
Tlf: +47 66 75 33 00 

Ελλάδα 
MEDA Pharmaceuticals AE 
Ευρυτανίας 3 
GR-15231 Χαλάνδρι-Αττική 
Τηλ: +30 210 6 77 5690 
 

Österreich 
MEDA Pharma GmbH 
Guglgasse 15 
A-1110 Wien 
Tel: + 43 1 86 390 0 

España 
MEDA Pharma S.A.U. 
Avenida de Castilla, 2 
Parque Empresarial San Fernando 
Edificio Berlin 
E-28830 San Fernando de Henares (Madrid) 
Tel: +34 91 669 93 00 
 

Polska 
Meda Pharmaceuticals Sp. z o.o. 
Al. Jana Pawła II nr 15 
PL-00-828 Warszawa 
Tel: +48 22 697 7100 
 

France 
MEDA PHARMA  SAS  
25 Bd. de l´Amiral Bruix 
F-75016 Paris 
Tél : +33 156 64 10 70 

Portugal 
MEDA Pharma Produtos Farmacêuticos SA  
Rua do Centro Cultural 13 
P-1749-066 Lisboa 
Tel: +351 21 842 0300 
 

Hrvatska 
Medical Intertrade d.o.o.  
Dr. Franje Tudmana 3 
10431 Sveta Nedelja 
Tel: +385 1 3374 010 

România 
MEDA Pharmaceuticals Switzerland GmbH 
Reprezentanta Romania 
Calea Floreasca 141-143, et.4 
014467 Bucuresti 
Tel.: +40 21 230 90 30 
 

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Ireland 
Meda Health Sales Ireland Limited, 
Unit 34/35, Block A, 
Dunboyne Business Park, 
Dunboyne 
Co. Meath 
Tel: +353 1 802 66 24 

Slovenija  
MEDA Pharmaceuticals Switzerland GmbH,  
Podružnica Ljubljana 
Cesta 24. junija 23 
Ljubljana 
Tel: +386 59 096 951 
 

Ísland 
Meda AB 
Box 906 
S-170 09 Solna 
Svíþjóð. 
Sími: +46 8 630 1900 
 

Slovenská republika 
MEDA Pharma spol. s r.o.. 
Trnavská cesta 50 
SK-821 02 Bratislava 
Tel: +421 2 4914 0171 

Italia 
Meda Pharma S.p.A. 
Viale Brenta, 18 
I-20139 Milano 
Tel: +39 02 57 416 1 
 

Suomi/Finland 
Meda Oy 
Vaisalantie 4/ Vaisalavägen 4 
FI-02130 Espoo/ Esbo 
Puh/Tel: +358 20 720 9550 

Κύπρος 
MEDA Pharmaceuticals AE 
Ευρυτανίας 3 
GR-15231 Χαλάνδρι-Αττική 
Ελλάδα 
Τηλ: +30 210 6 77 5690 
 

Sverige 
Meda AB 
Box 906 
S-170 09 Solna 
Tel: +46 8 630 1900 

Latvija 
Meda Pharma SIA 
Vienības gatve 109 
LV-1058 Riga, Latvia  
Tel.: +371 67616137 
 

United Kingdom 
Meda Pharmaceuticals Ltd. 
Skyway House 
Parsonage Road  
Takeley 
Bishop's Stortford 
CM22 6PU - UK 
Tel: +44 845 460 0000 
 

 
 
This leaflet was last approved in 
 
Detailed information on this medicine is available on the European Medicines Agency web site:  
http://www.ema.europa.eu/.  

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Sonata 10 mg hard capsules 
zaleplon 

 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 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 signs of illness are the same as yours. 
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet: 
1. What Sonata is and what it is used for 
2. What you need to know before you take Sonata 
3. How to take Sonata 
4. Possible side effects 
5. How to store Sonata 
6. Contents of the pack and other information 
 
 
1. What Sonata is and what it is used for 
 
Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which 
consists of preparations with hypnotic actions. 
 
Sonata 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. 
 
  
2. What you need to know before you take Sonata  
 
Do not take Sonata 
 
 if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in 

section 6). 
 if you have sleep apnoea syndrome (stopping breathing for short periods while asleep). 
 if you have severe kidney or liver problems. 
 if you have myasthenia gravis (very weak or tired muscles). 
 if you have severe breathing or chest problems. 
 
If you are in any doubt about whether you have any of these conditions, do ask your doctor. 
Children and adolescents under 18 years of age must not take Sonata. 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking 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 medicines 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. Once physical dependence has 
developed, abrupt termination of treatment may be accompanied by withdrawal symptoms. 

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These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion 
and irritability. 

 Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to. 
 Do not use a second dose of Sonata within a single night. 
 If your sleeplessness persists or worsens after a short course of Sonata treatment contact your 

doctor. 
 There is a chance that you may experience a certain type of temporary memory loss (amnesia) 

and lack of coordination when taking sleep medicines. This can usually be avoided if you 
remain inactive for at least 4 hours after taking Sonata. 

 There is a chance that you may experience somnambulism (sleepwalking), including eating or 
driving while not fully awake with no memory of the event. If you experience these events, 
contact your doctor immediately.  

 Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, 
rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, 
extroversion that seems out of character and other behavioural effects have been reported 
following use of any medicines belonging to the sleep inducing group, including Sonata.  These 
reactions may be active substance-induced, spontaneous in origin, or a result of an underlying 
psychiatric or physical disorder. They are more likely to occur in the elderly. If you experience 
these events, contact your doctor immediately. 

 Rare cases of severe allergic reactions have been reported. An allergic reaction may include a 
rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and 
vomiting. If you experience any of these events, contact your doctor immediately. 

 
Children and adolescents 
Do not give this medicine to children and adolescents under 18 years of age. 
 
Other medicines and Sonata 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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), medicines used for strong pain relief (narcotic 
analgesics), medicines used for the treatment of seizures/convulsions (antiepileptic medicines), 
medicines used for loss of feeling/insensibility (anaesthetics), and medicines used in the treatment of 
allergies (sedative antihistamines). Drinking alcohol while being treated with Sonata may also cause 
you to feel drowsy the next day. Never drink alcohol while you are being treated with Sonata (see 
“Warnings and precautions”). 
 
 
You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or 
erythromycin (an antibiotic). 
 
Sonata with food, drink and alcohol 
 
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 “Warnings and precautions”). 
 

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Pregnancy and breast-feeding 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor or pharmacist for advice before taking this medicine. Sonata should not be taken at these 
times because there are not enough clinical data available to assess its safety during pregnancy and 
breast-feeding. 
 
Driving and using machines 
 
Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness. This 
feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if 
you are already taking another central nervous system depressant or if you are drinking alcohol (see 
‘other medicines and Sonata’). If affected do not drive or operate machinery. 
 
 
Sonata contains lactose. 
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 
before taking this medicinal product. 
 
 
3. How to take Sonata 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The usual dose for adults is 10 mg 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. 
 
There are different doses for people who are 65 or older, and those who have mild to moderate liver 
problems: 
 65 or older: Take one 5 mg capsule  
 Mild to moderate liver problems: Take one 5 mg capsule 
 
Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will 
change colour and become cloudy. 
 
If you take more Sonata than you should 
 
Contact a doctor immediately and say how many capsules you have taken. Do not go 
unaccompanied to seek medical help. 
 
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses 
probably leading to a coma. 
 
If you forget to take Sonata 
 
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 medicine, ask your doctor or pharmacist. 

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4. Possible side effects 
 
Like all medicines, this medicine 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. 
 
The frequency of possible side effects listed below is defined using the following convention: 
very common (affects more than 1 user in 10) 
common (affects 1 to 10 users in 100) 
uncommon (affects 1 to 10 users in 1,000) 
rare (affects 1 to 10 users in 10,000) 
very rare (affects less than 1 user in 10,000) 
not known (frequency cannot be estimated from the available data) 
 
Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. 
in the extremities (paraesthesia); painful menstruation  
 
Uncommon side effects include: dizziness; weakness; reduced coordination of movements; 
unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; 
irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, 
decreased inhibition, aggressiveness, 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 
extremities (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. An allergic reaction may also include a rash, 
itching, or swelling of the face, lips, throat or tongue. 
 
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. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
 
5. How to store Sonata 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date 
refers to the last day of that month. 
 
This medicinal product does not require any special temperature storage conditions. 
 
If you have any further questions, please consult your doctor or pharmacist. 
 

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Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Sonata contains 
 
The active substance in each Sonata hard capsule is zaleplon 10 mg. 
 
The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium 
lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide 
(E171). 
 
Ingredients of the capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulphate. Printing 
inks on the shell contain the following (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 10 mg hard capsules, which contain a light blue powder, have a white cap and white body, with 
pink imprint “10 mg”. They are packed in blisters. Each pack contains 7, 10 or 14 hard capsules.  
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation holder: 
Meda AB 
Pipers väg 2A 
S-170 73 Solna  
Sweden 

Manufacturer: 
MEDA Manufacturing GmbH 
Neurather Ring 1 
51063 Cologne 
Germany 
 
  

 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
MEDA Pharma S.A./N.V. 
Chaussée de la Hulpe 166/ 
Terhulpsesteenweg 166 
B-1170 Brussels 
Tél/Tel: +32 2 5 04 08 11 
 

Lietuva 
Meda Pharma SIA 
Veiverių 134 
LT – 46352 Kaunas 
Tel.: +370 37 330 509 
 

България 
ТП Меда Фармасойтикалс 
Ул. Одрин 71-75, ет.2, ап 7 
1303 София 
Тел.: +359 2 4177977 
 

Luxembourg/Luxemburg 
MEDA Pharma S.A./N.V. 
Chaussée de la Hulpe 166/ 
Terhulpsesteenweg 166 
B-1170 Brussels 
Belgique/Belgien 
Tél/Tel: +32 2 5 04 08 11 
 

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Česká republika 
MEDA Pharma s.r.o. 
Kodaňská 1441/46 
CZ 100 10 Praha 10 
Tel: +420 234 064 203 
 

Magyarország 
MEDA PHARMA Hungary Kereskedelmi Kft. 
H-1139 Budapest 
Váci ut 91 
Tel.: +36 1 236 3410 
 

Danmark 
Meda A/S 
Solvang 8 
DK-3450 Allerød 
Tlf: +45 44 52 88 88 
 

Malta 
Alfred Gera & Sons Ltd.  
10, Triq il-Masġar 
Qormi QRM 3217 
Tel:  +356 2092 4000 
 

Deutschland 
MEDA Pharma GmbH & Co. KG 
Benzstraße 1 
D-61352 Bad Homburg v.d.H. 
Tel: + 49 6172 888 01 
 

Nederland 
MEDA Pharma B.V. 
Krijgsman 20 
NL-1186 DM Amstelveen 
Tel: +31 20 751 65 00 

Eesti 
Meda Pharma SIA 
Narva mnt 11D  
EE - 10151 Tallinn, Eesti  
Tel. + 372 6261 025 
 

Norge 
Meda A/S 
Askerveien 61 
N-1384 Asker 
Tlf: +47 66 75 33 00 

Ελλάδα 
MEDA Pharmaceuticals AE 
Ευρυτανίας 3 
GR-15231 Χαλάνδρι-Αττική 
Τηλ: +30 210 6 77 5690 
 

Österreich 
MEDA Pharma GmbH 
Guglgasse 15 
A-1110 Wien 
Tel: + 43 1 86 390 0 

España 
MEDA Pharma S.A.U. 
Avenida de Castilla, 2 
Parque Empresarial San Fernando 
Edificio Berlin 
E-28830 San Fernando de Henares (Madrid) 
Tel: +34 91 669 93 00 
 

Polska 
Meda Pharmaceuticals Sp. z o.o. 
Al. Jana Pawła II nr 15 
PL-00-828 Warszawa 
Tel: +48 22 697 7100 
 

France 
MEDA PHARMA  SAS  
25 Bd. de l´Amiral Bruix 
F-75016 Paris 
Tél : +33 156 64 10 70 

Portugal 
MEDA Pharma Produtos Farmacêuticos SA  
Rua do Centro Cultural 13 
P-1749-066 Lisboa 
Tel: +351 21 842 0300 
 

Hrvatska 
Medical Intertrade d.o.o.  
Dr. Franje Tudmana 3 
10431 Sveta Nedelja 
Tel: +385 1 3374 010 

România 
MEDA Pharmaceuticals Switzerland GmbH 
Reprezentanta Romania 
Calea Floreasca 141-143, et.4 
014467 Bucuresti 
Tel.: +40 21 230 90 30 
 

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Ireland 
Meda Health Sales Ireland Limited, 
Unit 34/35, Block A, 
Dunboyne Business Park, 
Dunboyne 
Co. Meath 
Tel: +353 1 802 66 24 

Slovenija  
MEDA Pharmaceuticals Switzerland GmbH,  
Podružnica Ljubljana 
Cesta 24. junija 23 
Ljubljana 
Tel: +386 59 096 951 
 

Ísland 
Meda AB 
Box 906 
S-170 09 Solna 
Svíþjóð. 
Sími: +46 8 630 1900 
 

Slovenská republika 
MEDA Pharma spol. s r.o.. 
Trnavská cesta 50 
SK-821 02 Bratislava 
Tel: +421 2 4914 0171 

Italia 
Meda Pharma S.p.A. 
Viale Brenta, 18 
I-20139 Milano 
Tel: +39 02 57 416 1 
 

Suomi/Finland 
Meda Oy 
Vaisalantie 4/ Vaisalavägen 4 
FI-02130 Espoo/ Esbo 
Puh/Tel: +358 20 720 9550 

Κύπρος 
MEDA Pharmaceuticals AE 
Ευρυτανίας 3 
GR-15231 Χαλάνδρι-Αττική 
Ελλάδα 
Τηλ: +30 210 6 77 5690 
 

Sverige 
Meda AB 
Box 906 
S-170 09 Solna 
Tel: +46 8 630 1900 

Latvija 
Meda Pharma SIA 
Vienības gatve 109 
LV-1058 Riga, Latvia  
Tel.: +371 67616137 
 

United Kingdom 
Meda Pharmaceuticals Ltd. 
Skyway House 
Parsonage Road  
Takeley 
Bishop's Stortford 
CM22 6PU - UK 
Tel: +44 845 460 0000 
 

 
 
This leaflet was last approved in 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  
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Annex IV 

Scientific conclusions and grounds recommending the variation to the terms of the Marketing 
Authorisation 

 
 
 
 
 

 

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Scientific conclusions 

Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of 
CHMP are as follows:  

Literature articles regarding next day effects on driving and mental alertness were published during the 
reporting period which examined these effects with zaleplon and other agents of the class. While there 
were no significant findings in relation to zaleplon, a small number of cases have been reported in the 
post-marketing setting, although mostly in combination with other CNS depressant agents and at doses 
greater than 10mg.  

Warnings already exist in the zaleplon product information however based on the available information 
the PRAC considered it prudent within this procedure to strengthen the wording in SmPC and PL to ensure 
clear information is available for patients and healthcare professionals given the potentially serious 
consequences of next day psychomotor impairment.  

Therefore, in view of available data regarding next day effects on driving and mental alertness, the PRAC 
considered that changes to the product information were warranted.  

  

The CHMP agrees with the scientific conclusions made by the PRAC. 

 

Grounds recommending the variation to the terms of the Marketing Authorisation  

On the basis of the scientific conclusions for zaleplon the CHMP is of the opinion that the benefit-risk 
balance of the medicinal product containing zaleplon is favourable subject to the proposed changes to the 
product information 

The CHMP recommends that the terms of the Marketing Authorisation should be varied. 

 
 
 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVEUSE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
	Scientific conclusions and grounds recommending the variation to the terms of the MarketingAuthorisation