Zaleplon: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Zaleplon. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Headache42%
Dizziness9%
Nausea8%
Asthenia7%
Abdominal pain6%
Somnolence6%
Amnesia4%
Eye pain4%
Dysmenorrhea4%
Paresthesia3%
Malaise2%
Anorexia2%
Depersonalization2%
Hypesthesia2%
Tremor2%
Abnormal vision2%
Hyperacusis2%
Parosmia2%
Photosensitivity reaction1%
Colitis1%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Sonata is indicated for the short-term treatment of insomnia. Sonata has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see Clinical Trials under CLINICAL PHARMACOLOGY ). It has not been shown to increase total sleep time or decrease the number of awakenings. The clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. The final formal assessments of sleep latency were performed at the end of treatment.

Source: FDA labeling via NIH DailyMed (set 43ac81cb…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.