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Zaleplon Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 7, 2023.

Applies to zaleplon: oral capsule.

Warning

Oral route (Capsule)

Complex sleep behaviors including sleep-walking, sleep driving, and engaging in other activities while not fully awake may occur following use of zaleplon. Some of these events may result in serious injuries, including death. Discontinue zaleplon immediately if a patient experiences a complex sleep behavior.

Serious side effects of Zaleplon

Along with its needed effects, zaleplon may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking zaleplon:

Less common

Rare

Get emergency help immediately if any of the following symptoms of overdose occur while taking zaleplon:

Symptoms of overdose

Other side effects of Zaleplon

Some side effects of zaleplon may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Rare

For Healthcare Professionals

Applies to zaleplon: oral capsule.

General

The most commonly reported side effects included headache, dizziness, nausea, asthenia, and somnolence.[Ref]

Nervous system

Very common (10% or more): Headache (up to 42%)

Common (1% to 10%): Amnesia, difficulty concentrating, dizziness, hypertonia, hypesthesia, migraine, paresthesia, parosmia, somnolence, taste perversion, tremor, vertigo

Uncommon (0.1% to 1%): Abnormal gait, ataxia, hyperesthesia, hyperkinesia, hypotonia, incoordination, neuralgia, nystagmus

Rare (less than 0.1%): Central nervous system (CNS) stimulation, cerebral ischemia, decreased reflexes, dysarthria, dystonia, facial paralysis, hypokinesia, increased reflexes, myoclonus, neuropathy, slurred speech, stupor, taste loss, visual field defect[Ref]

Psychiatric

Common (1% to 10%): Abnormal thinking, anxiety, confusion, depersonalization, depression, hallucinations, nervousness

Uncommon (0.1% to 1%): Agitation, apathy, decreased libido, emotional lability, euphoria, insomnia

Rare (less than 0.1%): Bruxism, delusions, hostility, psychomotor retardation, sleep talking, sleep walking

Postmarketing reports: Nightmares[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, colitis, constipation, dry mouth, dyspepsia, nausea

Uncommon (0.1% to 1%): Circumoral paresthesia, eructation, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, glossitis, mouth ulceration, rectal hemorrhage, stomatitis

Rare (less than 0.1%): Aphthous stomatitis, cardiospasm, cheilitis, duodenal ulcer, dysphagia, enteritis, gum hemorrhage, increased salivation, intestinal obstruction, peptic ulcer, tongue discoloration, tongue edema, ulcerative stomatitis[Ref]

Other

Common (1% to 10%): Asthenia, ear pain, fever, hyperacusis, malaise

Uncommon (0.1% to 1%): Chills, face edema, hangover effect, substernal chest pain, tinnitus

Rare (less than 0.1%): Deafness, labyrinthitis[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, arthritis, back pain, myalgia

Uncommon (0.1% to 1%): Arthrosis, bursitis, joint disorder, joint pain, joint stiffness, joint swelling, neck rigidity, myasthenia, tenosynovitis

Rare (less than 0.1%): Myositis, osteoporosis, trismus[Ref]

Dermatologic

Common (1% to 10%): Photosensitivity reaction, pruritus, rash

Uncommon (0.1% to 1%): Acne, alopecia, contact dermatitis, dry skin, ecchymosis, eczema, maculopapular rash, skin hypertrophy, sweating, urticaria, vesiculobullous rash

Rare (less than 0.1%): Melanosis, psoriasis, purpura, pustular rash, skin discoloration[Ref]

Ocular

Common (1% to 10%): Abnormal vision, conjunctivitis, eye pain

Uncommon (0.1% to 1%): Diplopia, dry eyes, photophobia, watery eyes

Rare (less than 0.1%): Abnormality of accommodation, blepharitis, cataract specified, corneal erosion, eye hemorrhage, glaucoma, ptosis, retinal detachment[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, peripheral edema

Uncommon (0.1% to 1%): Angina pectoris, bundle branch block, edema, generalized edema, hypertension, hypotension, palpitation, tachycardia, vasodilation, ventricular extrasystoles

Rare (less than 0.1%): Bigeminy, cyanosis, pericardial effusion, postural hypotension, sinus bradycardia, thrombophlebitis, ventricular tachycardia[Ref]

Respiratory

Common (1% to 10%): Bronchitis, epistaxis

Uncommon (0.1% to 1%): Asthma, dyspnea, laryngitis, pneumonia, snoring, voice alteration

Rare (less than 0.1%): Apnea, hiccup, hyperventilation, increased sputum, pleural effusion, pulmonary embolus[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea

Uncommon (0.1% to 1%): Bladder pain, breast pain, cystitis, decreased urine stream, dysuria, hematuria, impotence, menorrhagia, metrorrhagia, urinary frequency, urinary incontinence, urinary urgency, vaginitis

Rare (less than 0.1%): Albuminuria, delayed menstrual period, leukorrhea, menopause, urethritis, urinary retention, vaginal hemorrhage[Ref]

Metabolic

Common (1% to 10%): Anorexia

Uncommon (0.1% to 1%): Gout, hypercholesteremia, increased appetite, thirst, weight gain

Rare (less than 0.1%): Diabetes mellitus, hyperglycemia, hyperuricemia, hypoglycemia, hypoglycemic reaction, ketosis, lactose intolerance, weight loss[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, lymphadenopathy

Rare (less than 0.1%): Eosinophilia, leukocytosis, lymphocytosis[Ref]

Renal

Uncommon (0.1% to 1%): Kidney calculus, kidney pain[Ref]

Hepatic

Rare (less than 0.1%): Abnormal liver function tests, bilirubinemia, biliary pain, cholelithiasis, increased ALT, increased AST[Ref]

Endocrine

Rare (less than 0.1%): Goiter, hypothyroidism[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic/anaphylactoid reactions, severe anaphylactic/anaphylactoid reactions[Ref]

Frequently asked questions

References

1. Product Information. Sonata (zaleplon). Wyeth-Ayerst Laboratories. 2001;PROD.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.