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Zaleplon Side Effects

In Summary

More frequently reported side effects include: amnesia and dizziness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to zaleplon: oral capsule

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

  • Anxiety
  • blurred or double vision
  • not feeling like oneself

Rare

  • Nosebleed
  • seeing, hearing, smelling, or feeling things that are not there

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

Symptoms of Overdose

  • Confusion
  • clumsiness or unsteadiness, severe
  • dizziness or fainting
  • drowsiness, severe
  • weak muscle tone
  • troubled breathing
  • unusual dullness or feeling sluggish

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

  • Abdominal pain
  • burning, prickling, or tingling sensation
  • constipation
  • cough
  • difficulty concentrating
  • drowsiness
  • dryness of mouth
  • excess muscle tone
  • eye pain
  • fever
  • heartburn, indigestion, or acid stomach
  • itching
  • itching or burning eyes
  • joint stiffness and/or pain
  • memory loss
  • menstrual pain
  • mental depression
  • nervousness
  • sensitive hearing
  • severe headache
  • shortness of breath
  • skin rash
  • tightness in chest
  • trembling or shaking
  • troubled breathing
  • unusual weakness or tiredness
  • wheezing

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

  • Abdominal and muscle cramps
  • convulsions (seizures)
  • increased sweating
  • sadness
  • trembling or shaking
  • vomiting

For Healthcare Professionals

Applies to zaleplon: oral capsule

Nervous system

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

Common (1% to 10%): Dizziness, amnesia, confusion, hypertonia, hypesthesia, paresthesia, somnolence, tremor, vertigo, migraine, taste perversion

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

Rare (less than 0.1%): CNS stimulation, cerebral ischemia, dysarthria, dystonia, facial paralysis, hypokinesia, myoclonus, neuropathy, psychomotor retardation, decreased reflexes, increased reflexes, slurred speech, stupor

Frequency not reported: Seizures[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

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

Rare (less than 0.1%): Purpura, melanosis, psoriasis, pustular rash, skin discoloration

Gastrointestinal

Common (1% to 10%): Nausea, abdominal pain, colitis, constipation, dry mouth, dyspepsia

Uncommon (0.1% to 1%): Eructation, esophagitis, flatulence, gastritis, gastroenteritis, gingivitis, glossitis, mouth ulceration, stomatitis

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

Genitourinary

Common (1% to 10%): Dysmenorrhea

Uncommon (0.1% to 1%): Breast pain, rectal hemorrhage, bladder pain, melena, cystitis, decreased urine stream, dysuria, hematuria, 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%): Increased appetite, gout, hypercholesteremia, weight gain

Rare (less than 0.1%): Weight loss[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, arthritis, myalgia

Uncommon (0.1% to 1%): Neck rigidity, arthrosis, bursitis, joint disorder (mainly swelling, stiffness, pain), myasthenia, tenosynovitis

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

Ocular

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

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

Rare (less than 0.1%): Ptosis, abnormality of accommodation, blepharitis, cataract specified, corneal erosion, eye hemorrhage, glaucoma, retinal detachment, visual field defect[Ref]

Other

Common (1% to 10%): Asthenia, malaise, photosensitivity reaction, peripheral edema, ear pain, hyperacusis, parosmia, chest pain, fever

Uncommon (0.1% to 1%): Substernal chest pain, chills, face edema, generalized edema, hangover effect, tinnitus, thirst[Ref]

Psychiatric

Common (1% to 10%): Depersonalization, hallucinations, anxiety, depression, nervousness, abnormal thinking (mainly difficulty concentrating)

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

Rare (less than 0.1%): Delusions, hostility, sleep talking, sleep walking

Postmarketing reports: Nightmares

Respiratory

Common (1% to 10%): Epistaxis, bronchitis

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

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

Cardiovascular

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

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

Hematologic

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

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

Renal

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

Endocrine

Rare (less than 0.1%): Diabetes mellitus, goiter, hypothyroidism

Hepatic

Rare (less than 0.1%): Abnormal liver function tests, bilirubinemia, increased AST (SGOT), increased ALT (SGPT), biliary pain

Hypersensitivity

Postmarketing reports: Anaphylactic/anaphylactoid reactions

References

1. "Product Information. Sonata (zaleplon)" Wyeth-Ayerst Laboratories, Philadelphia, PA.

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.

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