Sonata

Sonata (zaleplon) is a non-benzodiazepine sedative hypnotic drug used to treat insomnia. Sonata is available in generic form. Common side effects of Sonata include:

• dizziness,
• drowsiness,
• short-term memory loss,
• problems with memory or concentration,
• lack of coordination (especially during the first 2 hours after you take the medication),
• "hangover" feeling,
• numbness or tingling,
• anxiety,
• depression,
• nervous feeling,
• problems with vision,
• headache,
• nausea,
• stomach pain,
• loss of appetite,
• constipation,
• dry mouth,
• increased menstrual pain (cramps),
• back pain,
• joint or muscle pain, or
• mild skin rash.

Taking Sonata properly just before falling asleep will reduce your risk of these effects. Some people using Sonata have engaged in activity such as driving, eating, or making phone calls and later having no memory of the activity. If this happens to you, stop taking Sonata and talk with your doctor about another treatment for your sleep disorder. Tell your doctor if you have unlikely but serious side effects of Sonata including:

• mental/mood changes (e.g., agitation, confusion, seeing or hearing things that are not there, rare thoughts of suicide), or
• unusual behavior.

The dose of Sonata should be individualized. The recommended dose for most adults is 10 mg. For some patients, 5 mg may be a sufficient dose. Sonata may interact with cimetidine, thioridazine, promethazine, cyclosporine, rifampin, antibiotics, antidepressants, narcotic pain medications, muscle relaxers, seizure medications, or anti-anxiety medications. Tell your doctor all medications you are taking. Sonata should be used only when prescribed during pregnancy. Discuss the risks and benefits with your doctor. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding. Sonata may be habit-forming and should be used only by the person it was prescribed for. You may have withdrawal symptoms if you stop taking Sonata. Do not stop taking Sonata suddenly without first talking to your doctor.

Our Sonata (zaleplon) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Sonata Consumer Information

Zaleplon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;
• memory problems, unusual thoughts or behavior;
• thoughts of hurting yourself; or
• confusion, hallucinations (hearing or seeing things).

Common side effects may include:

• day-time drowsiness, dizziness, "hangover" feeling;
• feeling light-headed;
• problems with coordination; or
• numbness, tingling, or prickly feeling on your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sonata (Zaleplon)

 

Sonata Professional Information

SIDE EFFECTS

The premarketing development program for Sonata included zaleplon exposures in patients and/or normal subjects from 2 different groups of studies: approximately 900 normal subjects in clinical pharmacology/pharmacokinetic studies; and approximately 2,900 exposures from patients in placebo-controlled clinical effectiveness studies, corresponding to approximately 450 patient exposure years. The conditions and duration of treatment with Sonata varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, and short-term or longer-term exposure. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed In Short-Term, Placebo-Controlled Trials

Adverse Events Associated With Discontinuation Of Treatment

In premarketing placebo-controlled, parallel-group phase 2 and phase 3 clinical trials, 3.1% of 744 patients who received placebo and 3.7% of 2,149 patients who received Sonata discontinued treatment because of an adverse clinical event. This difference was not statistically significant. No event that resulted in discontinuation occurred at a rate of ≥ 1%.

Adverse Events Occurring At An Incidence Of 1% Or More Among Sonata 20 Mg-Treated Patients

Table 1 enumerates the incidence of treatment-emergent adverse events for a pool of three 28night and one 35-night placebo-controlled studies of Sonata at doses of 5 mg or 10 mg and 20 mg. The table includes only those events that occurred in 1% or more of patients treated with Sonata 20 mg and that had a higher incidence in patients treated with Sonata 20 mg than in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

Table 1: Incidence (%) of Treatment-Emergent Adverse Events in Long-Term (28 and 35 Nights) Placebo-Controlled Clinical Trials of Sonata^a

Body System	Placebo	Sonata 5 mg or 10 mg	Sonata 20 mg
Preferred Term	(n = 344)	(n = 569)	(n = 297)
Body as a whole
Abdominal pain	3	6	6
Asthenia	5	5	7
Headache	35	30	42
Malaise	<1	<1	2
Photosensitivity reaction	<1	<1	1
Digestive system
Anorexia	<1	<1	2
Colitis	0	0	1
Nausea	7	6	8
Metabolic and nutritional
Peripheral edema	<1	<1	1
Nervous system
Amnesia	1	2	4
Confusion	<1	<1	1
Depersonalization	<1	<1	2
Dizziness	7	7	9
Hallucinations	<1	<1	1
Hypertonia	<1	1	1
Hypesthesia	<1	<1	2
Paresthesia	1	3	3
Somnolence	4	5	6
Tremor	1	2	2
Vertigo	<1	<1	1
Respiratory system
Epistaxis	<1	<1	1
Special senses
Abnormal vision	<1	<1	2
Ear pain	0	<1	1
Eye pain	2	4	3
Hyperacusis	<1	1	2
Parosmia	<1	<1	2
Urogenital system
Dysmenorrhea	2	3	4
a) Events for which the incidence for Sonata 20 mg-treated patients was at least 1% and greater than the incidence among placebo-treated patients. Incidence greater than 1% has been rounded to the nearest whole number.

Other Adverse Events Observed During The Premarketing Evaluation Of Sonata

Listed below are COSTART terms that reflect treatment-emergent adverse events as defined in the introduction to the ADVERSE REACTIONS section. These events were reported by patients treated with Sonata (zaleplon) at doses in a range of 5 mg/day to 20 mg/day during premarketing phase 2 and phase 3 clinical trials throughout the United States, Canada, and Europe, including approximately 2,900 patients. All reported events are included except those already listed in Table 1 or elsewhere in labeling, those events for which a drug cause was remote, and those event terms that were so general as to be uninformative. It is important to emphasize that although the events reported occurred during treatment with Sonata, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1,000 patients; rare events are those occurring in fewer than 1/1,000 patients.

Body as a whole -Frequent: back pain, chest pain, fever; Infrequent: chest pain substernal, chills, face edema, generalized edema, hangover effect, neck rigidity.

Cardiovascular system -Frequent: migraine; Infrequent: angina pectoris, bundle branch block, hypertension, hypotension, palpitation, syncope, tachycardia, vasodilatation, ventricular extrasystoles; Rare: bigeminy, cerebral ischemia, cyanosis, pericardial effusion, postural hypotension, pulmonary embolus, sinus bradycardia, thrombophlebitis, ventricular tachycardia.

Digestive system -Frequent: constipation, dry mouth, dyspepsia; Infrequent: eructation, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, glossitis, increased appetite, melena, mouth ulceration, rectal hemorrhage, stomatitis; Rare: aphthous stomatitis, biliary pain, bruxism, cardiospasm, cheilitis, cholelithiasis, duodenal ulcer, dysphagia, enteritis, gum hemorrhage, increased salivation, intestinal obstruction, abnormal liver function tests, peptic ulcer, tongue discoloration, tongue edema, ulcerative stomatitis.

Endocrine system -Rare: diabetes mellitus, goiter, hypothyroidism.

Hemic and lymphatic system -Infrequent: anemia, ecchymosis, lymphadenopathy; Rare: eosinophilia, leukocytosis, lymphocytosis, purpura.

Metabolic and nutritional -Infrequent: edema, gout, hypercholesteremia, thirst, weight gain; Rare: bilirubinemia, hyperglycemia, hyperuricemia, hypoglycemia, hypoglycemic reaction, ketosis, lactose intolerance, AST (SGOT) increased, ALT (SGPT) increased, weight loss.

Musculoskeletal system -Frequent: arthralgia, arthritis, myalgia; Infrequent: arthrosis, bursitis, joint disorder (mainly swelling, stiffness, and pain), myasthenia, tenosynovitis; Rare: myositis, osteoporosis.

Nervous system -Frequent: anxiety, depression, nervousness, thinking abnormal (mainly difficulty concentrating); Infrequent: abnormal gait, agitation, apathy, ataxia, circumoral paresthesia, emotional lability, euphoria, hyperesthesia, hyperkinesia, hypotonia, incoordination, insomnia, libido decreased, neuralgia, nystagmus; Rare: CNS stimulation, delusions, dysarthria, dystonia, facial paralysis, hostility, hypokinesia, myoclonus, neuropathy, psychomotor retardation, ptosis, reflexes decreased, reflexes increased, sleep talking, sleep walking, slurred speech, stupor, trismus.

Respiratory system -Frequent: bronchitis; Infrequent: asthma, dyspnea, laryngitis, pneumonia, snoring, voice alteration; Rare: apnea, hiccup, hyperventilation, pleural effusion, sputum increased.

Skin and appendages -Frequent: pruritus, rash; Infrequent: acne, alopecia, contact dermatitis, dry skin, eczema, maculopapular rash, skin hypertrophy, sweating, urticaria, vesiculobullous rash; Rare: melanosis, psoriasis, pustular rash, skin discoloration.

Special senses -Frequent: conjunctivitis, taste perversion; Infrequent: diplopia, dry eyes, photophobia, tinnitus, watery eyes; Rare: abnormality of accommodation, blepharitis, cataract specified, corneal erosion, deafness, eye hemorrhage, glaucoma, labyrinthitis, retinal detachment, taste loss, visual field defect.

Urogenital system -Infrequent: bladder pain, breast pain, cystitis, decreased urine stream, dysuria, hematuria, impotence, kidney calculus, kidney pain, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, urinary urgency, vaginitis; Rare: albuminuria, delayed menstrual period, leukorrhea, menopause, urethritis, urinary retention, vaginal hemorrhage.

Postmarketing Reports

Anaphylactic/anaphylactoid reactions, including severe reactions and nightmares.

Read the entire FDA prescribing information for Sonata (Zaleplon)

&Copy; Sonata Patient Information is supplied by Cerner Multum, Inc. and Sonata Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.