Zaleplon Side Effects

Some side effects of zaleplon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to zaleplon: oral capsule

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 while taking zaleplon: 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 of zaleplon may include:

• day-time drowsiness, dizziness, "hangover" feeling;

• problems with memory or concentration;

• numbness or tingling;

• anxiety, depression, nervous feeling;

• problems with vision;

• headache;

• 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.

For Healthcare Professionals

Applies to zaleplon: oral capsule

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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