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Sonata (Zaleplon) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 28-night 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 1
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

1 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.



REPORTS OF SUSPECTED SONATA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Sonata. The information is not vetted and should not be considered as verified clinical evidence.

Possible Sonata side effects / adverse reactions in 45 year old male

Reported by a physician from United States on 2012-01-09

Patient: 45 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Sonata
    Dosage: unk
    Administration route: Oral
    Indication: Insomnia

Depakote
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Geodon
    Dosage: 120 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-01



Possible Sonata side effects / adverse reactions in 45 year old male

Reported by a physician from United States on 2012-01-10

Patient: 45 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Geodon
    Dosage: 120 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-01

Sonata
    Dosage: unk
    Administration route: Oral
    Indication: Sleep Disorder

Depakote
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01



Possible Sonata side effects / adverse reactions in 45 year old male

Reported by a physician from United States on 2012-01-10

Patient: 45 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Geodon
    Dosage: 120 mg, 2x/day
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2009-01-01

Depakote
    Dosage: 250 mg, unk
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2008-01-01

Sonata
    Dosage: unk
    Administration route: Oral
    Indication: Sleep Disorder



See index of all Sonata side effect reports >>

Drug label data at the top of this Page last updated: 2014-08-26

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