Side Effects > Zaleplon

Zaleplon Side Effects

Brand Names: Sonata

Please note - some side effects for Zaleplon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zaleplon - for the Consumer

Zaleplon

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zaleplon:

Abnormal skin sensations; decreased sensitivity to touch; dizziness; drowsiness; incoordination; lightheadedness; muscle pain; short-term memory loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Zaleplon:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; agitation; bizarre behavior; changes in personality, mood, or behavior; daytime drowsiness; hallucinations; memory loss; shortness of breath; suicidal thoughts; worsening of depression.

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Zaleplon Side Effects - for the Professional

Zaleplon

The premarketing development program for Zaleplon 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 Zaleplon 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 Zaleplon 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 Zaleplon 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 Zaleplon 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 Zaleplon 20 mg and that had a higher incidence in patients treated with Zaleplon 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 Zaleplon1

Body System                Preferred Term	Placebo (n = 344)	Zaleplon  5 mg or 10 mg (n=569)	Zaleplon  20 mg (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 Zaleplon 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 Zaleplon

 
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 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 Zaleplon, 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.
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Side Effects by Body System

General

General side effects including headache (28% to 38%), asthenia (5% to 8%), fever (2%), malaise (<1% to 2 %), and photosensitivity (<1% to 1%) have been reported.

Nervous system

Nervous system side effects including dizziness (7% to 8%), somnolence (5%), amnesia (2% to 4%), anxiety (less than 1% to 3%), paresthesia (3%), depersonalization (less than 1% to 2%), tremor (2%), hypesthesia (less than 1% to 2%), hallucinations (less than 1% to 1%), and vertigo (less than 1% to 1%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (7% to 8%), dyspepsia (4% to 7%), abdominal pain (5% to 6%), anorexia (<1% to 2%), and colitis (1%) have been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia (5% to 7%) have been reported.

Ocular

Ocular side effects including eye pain (4%) and abnormal vision (<1 to 2%) have been reported.

Genitourinary

Genitourinary side effects including dysmenorrhea (2% to 4%) have been reported.

Other

Other side effects including hyperacusis (2%), parosmia (<1% to 2%), and ear pain (<1% to 1%) have been reported.

Respiratory

Respiratory side effects including epistaxis (<1% to 1%) have been reported.

Metabolic

Metabolic side effects including peripheral edema (<1% to 1%) have been reported.

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