Medical Editor: John P. Cunha, DO, FACOEP
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:
- 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,
- nervous feeling,
- problems with vision,
- stomach pain,
- loss of appetite,
- 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.
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.
Zaleplon may cause a severe allergic reaction. Stop taking zaleplon and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using zaleplon and call your doctor at once if you have any of these serious side effects:
- aggression, agitation, changes in behavior;
- thoughts of hurting yourself; or
- hallucinations (hearing or seeing things).
Less serious side effects may include:
- day-time drowsiness, dizziness, "hangover" feeling;
- problems with memory or concentration;
- numbness or tingling;
- anxiety, depression, nervous feeling;
- problems with vision;
- nausea, stomach pain, loss of appetite, constipation;
- dry mouth;
- increased menstrual pain (cramps);
- back pain, joint or muscle pain; or
- mild skin rash.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Sonata (Zaleplon)
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 5 mg or 10 mg
(n = 569)
|Sonata 20 mg
(n = 297)
|Body as a whole|
|Malaise||< 1||< 1||2|
|Photosensitivity reaction||< 1||< 1||1|
|Anorexia||< 1||< 1||2|
|Metabolic and nutritional|
|Peripheral edema||< 1||< 1||1|
|Confusion||< 1||< 1||1|
|Depersonalization||< 1||< 1||2|
|Hallucinations||< 1||< 1||1|
|Hypesthesia||< 1||< 1||2|
|Vertigo||< 1||< 1||1|
|Epistaxis||< 1||< 1||1|
|Abnormal vision||< 1||< 1||2|
|Ear pain||0||< 1||1|
|Parosmia||< 1||< 1||2|
|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.
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.
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.
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.
Anaphylactic/anaphylactoid reactions, including severe reactions, and nightmares.
Drug Abuse And Dependence
Controlled Substance Class
Sonata is classified as a Schedule IV controlled substance by federal regulation.
Abuse, Dependence, And Tolerance
Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug's effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.
Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.
Two studies assessed the abuse liability of Sonata at doses of 25 mg, 50 mg, and 75 mg in subjects with known histories of sedative drug abuse. The results of these studies indicate that Sonata has an abuse potential similar to benzodiazepine and benzodiazepine-like hypnotics.
The potential for developing physical dependence on Sonata and a subsequent withdrawal syndrome was assessed in controlled studies of 14-, 28-, and 35-night durations and in open-label studies of 6- and 12-month durations by examining for the emergence of rebound insomnia following drug discontinuation. Some patients (mostly those treated with 20 mg) experienced a mild rebound insomnia on the first night following withdrawal that appeared to be resolved by the second night. The use of the Benzodiazepine Withdrawal Symptom Questionnaire and examination of any other withdrawal-emergent events did not detect any other evidence for a withdrawal syndrome following abrupt discontinuation of Sonata therapy in pre-marketing studies.
However, available data cannot provide a reliable estimate of the incidence of dependence during treatment at recommended doses of Sonata. Other sedative/hypnotics have been associated with various signs and symptoms following abrupt discontinuation, ranging from mild dysphoria and insomnia to a withdrawal syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors, and convulsions. Seizures have been observed in two patients, one of which had a prior seizure, in clinical trials with Sonata. Seizures and death have been seen following the withdrawal of zaleplon from animals at doses many times higher than those proposed for human use. Because individuals with a history of addiction to, or abuse of, drugs or alcohol are at risk of habituation and dependence, they should be under careful surveillance when receiving Sonata or any other hypnotic.
Possible tolerance to the hypnotic effects of Sonata 10 mg and 20 mg was assessed by evaluating time to sleep onset for Sonata compared with placebo in two 28-night placebo-controlled studies and latency to persistent sleep in one 35-night placebo-controlled study where tolerance was evaluated on nights 29 and 30. No development of tolerance to Sonata was observed for time to sleep onset over 4 weeks.
Read the entire FDA prescribing information for Sonata (Zaleplon)
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