Summary

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

Applies to zaleplon: oral capsule.

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

• Anxiety
• blurred or double vision
• chest pain
• confusion about identity, place, and time
• discouragement
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling sad or empty
• fever
• general feeling of discomfort or illness
• hives, skin rash
• irritability
• lack of appetite
• lightheadedness
• loss of interest or pleasure
• not feeling like oneself
• shakiness and unsteady walk
• tightness in the chest
• trouble concentrating
• trouble sleeping
• troubled breathing
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual weakness or tiredness

Rare

• Anxiety
• attack, assault, or force
• black, tarry stools
• bladder pain
• bloody or cloudy urine
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in walking and balance
• chills
• cold sweats
• cough
• crying
• decreased awareness or responsiveness
• deep or fast breathing with dizziness
• delusions of persecution, mistrust, suspiciousness, or combativeness
• difficult, burning, or painful urination
• difficulty swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position
• dry mouth
• fainting
• false beliefs that cannot be changed by facts
• feeling of unreality
• fever
• frequent urge to urinate
• irregular heartbeat
• irritability
• itching skin
• lack of feeling or emotion
• light-colored stools
• lower back or side pain
• nausea
• numbness of the feet, hands, and around the mouth
• pale skin
• poor insight and judgment
• problems with memory or speech
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• quick to react or overreact emotionally
• rapidly changing moods
• restlessness
• seeing, hearing, or feeling things that are not there
• sense of detachment from self or body
• severe sleepiness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• swollen glands
• thoughts of killing oneself or changes in behavior
• tightness in the chest
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• troubled breathing with exertion
• uncaring
• unusual bleeding or bruising
• vomiting
• yellow eyes or skin
• unease or dissatisfaction with life

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

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

• Drowsiness
• headache
• muscle aches
• sleepiness or unusual drowsiness
• stuffy or runny nose

Less common

• Back pain
• being forgetful
• belching
• body aches or pain
• congestion
• diarrhea
• difficulty having a bowel movement
• difficulty with moving
• double vision
• feeling of constant movement of self or surroundings
• heartburn
• hoarseness
• indigestion
• longer or heavier menstrual periods
• loss of memory
• muscle pain or stiffness
• pain or tenderness around the eyes and cheekbones
• seeing double
• sensation of spinning
• stomach discomfort
• tender, swollen glands in the neck
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• voice changes

Rare

• Bad, unusual, or unpleasant (after) taste
• blemishes on the skin
• blindness
• blurred vision
• breast pain
• change in near or distance vision
• change in taste
• changes in patterns and rhythms of speech
• decreased interest in sexual intercourse
• difficulty in focusing the eyes
• eye pain
• feeling of warmth
• frequent urge to defecate
• inability to have or keep an erection
• increased appetite
• increased sensitivity of the skin to sunlight
• increased sweating
• itching of the vagina or genital area
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• pain during sexual intercourse
• paleness of the skin
• pimples
• redness of the face, neck, arms, and occasionally, upper chest
• redness or other discoloration of the skin
• severe sunburn
• slurred speech
• stomach upset
• straining while passing stool
• tearing
• thick, white vaginal discharge with no odor or with a mild odor
• weight loss

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]