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a nonbenzodiazepine sedative and hypnotic used in the short term treatment of insomnia; administered orally.



Pharmacologic class: Pyrazolopyrimidine, nonbenzodiazepine hypnotic

Therapeutic class: Sedative-hypnotic

Controlled substance schedule IV

Pregnancy risk category C


Binds to omega-1 receptor of gamma-aminobutyric acid receptor complex, relaxing smooth muscles, reducing anxiety, and producing sedation. Also has anticonvulsant effect.


Capsules: 5 mg, 10 mg

Indications and dosages


Adults younger than age 65: 10 mg P.O. at bedtime. Dosage above 20 mg is not recommended.

Dosage adjustment

• Mild to moderate hepatic impairment

• Elderly or debilitated patients


• Hypersensitivity to drug or its components


Use cautiously in:

• tartrazine sensitivity

• severe renal impairment (use not recommended), mild to moderate hepatic impairment, respiratory impairment, depression

• history of suicide attempt

• patients weighing less than 50 kg (110 lb)

• patients older than age 65

• pregnant or breastfeeding patients (use not recommended)

• children younger than age 18 (safety not established).


• Give at bedtime.

• Don't administer with high-fat meal.

Adverse reactions

CNS: headache, amnesia, anxiety, hallucinations, light-headedness, dizziness, drowsiness, depersonalization, transient memory or psychomotor impairment, incoordination, malaise, vertigo, asthenia, hyperesthesia, paresthesia, tremor

CV: peripheral edema

EENT: abnormal vision, eye pain, ear pain, hearing sensitivity, epistaxis

GI: nausea, abdominal pain, colitis, dyspepsia, anorexia

GU: dysmenorrhea

Musculoskeletal: myalgia

Skin: photosensitivity

Other: altered sense of smell, fever


Drug-drug. Cimetidine: decreased metabolism and increased effects of zaleplon

CNS depressants (including antihistamines, opioids, other sedative-hypnotics, phenothiazines, tricyclic antidepressants): additive CNS depression

CYP450-3A4 inducers (such as carbamazepine, phenobarbital, phenytoin, rifampin): decreased blood level and reduced efficacy of zaleplon

CYP450-3A4 inhibitors (such as erythromycin, ketoconazole): increased zaleplon blood level

Drug-food. High-fat meal: delayed drug absorption

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: increased CNS depression

Patient monitoring

• Monitor drug efficacy. Insomnia persisting after 7 to 10 days warrants reevaluation for underlying psychological or physical illness.

• Stay alert for adverse drug reactions.

Patient teaching

• Explain therapy to patient. Emphasize importance of taking drug just before bedtime or after trying to sleep-but only if he will be able to get at least 4 hours of sleep.

• Inform patient that high-fat meal slows drug absorption and delays drug effects.

• Caution patient to avoid driving and other hazardous activities while under drug's influence.

• Instruct patient to avoid alcohol during therapy.

• Tell patient rebound insomnia may occur for 1 or 2 nights after he stops taking drug.

• Advise female of childbearing age to notify prescriber if she is or plans to become pregnant or if she is breastfeeding.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, foods, herbs, and behaviors mentioned above.


/zal·e·plon/ (zal´ĕ-plon) a nonbenzodiazepine sedative and hypnotic used in the short term treatment of insomnia.


A sedative drug used to treat insomnia.


a sedative/hypnotic.
indication This drug is used to treat insomnia.
contraindication Known hypersensitivity to this drug prohibits its use.
adverse effects Adverse effects of this drug include dizziness, confusion, anxiety, amnesia, depersonalization, hallucinations, hypesthesia, paresthesia, somnolence, tremor, vertigo, nausea, abdominal pain, constipation, anorexia, colitis, dyspepsia, dry mouth, vision changes, ear/eye pain, oversensitivity to sound, parosmia, asthenia, fever, headache, myalgia, and dysmenorrhea. Common side effects include lethargy, drowsiness, and daytime sedation. It should not be used longer than 2 to 3 weeks or with alcohol. Its effectiveness is decreased when taken with a high-fat meal.


Sonata®, see there.
References in periodicals archive ?
Zaleplon had the greatest effect on psychomotor performance, followed by temazepam and zopiclone.
Earlier short-term studies have shown fewer residual effects and rebound insomnia with zaleplon (Sonata) than with other hypnotics.
Nonpharmacological Interventions Comfort Items * Eye mask * Lotion * Lavender aromatherapy bag * Decaffeinated herbal tea * Ear plugs * Reference to music channel and relaxation exercises Discuss any barriers to sleep Pharmacological Interventions First Choice * Melatonin 3 mg Second Choice * * Zaleplon (Sonata[R]) 5 mg (may repeat x 1 if ineffective) or * Diphenhydramine (Benadryl[R]) 25 mg (Do not give if patient is [greater than or equal to] 65.
zolpidem, and zaleplon, can also cause significant effects on driving.
In the elderly, these should be used judiciously as there may be ataxia and night falls Zaleplon, Zolpidem and Zopiclone are non benzodiazepine hypnotic (referred to as Z drugs).
Sparse data on the new hypnotics (eszopiclone, zaleplon, zolpidem, and ramelteon) suggest an increased risk of cancer, which is supported by studies demonstrating a carcinogenic effect in rodents.
BPD patients can often have concomitant insomnia and for this, NICE details basic advice regarding sleep hygiene and forwards on to the guidance on the use of zaleplon, zolpidem and zopiclone for the short-term pharmacological management of insomnia.
We know that the Z-drugs (zolpidem, zaleplon, and eszopiclone), some of the most widely used pharmacologies for insomnia, are benzodiazepine receptor agonists.
000 habitantes y cuyos costos superan los 3,45 millones de dolares, tambien se emplean las benzodiazepinas y algunos nuevos hipnoticos como zolpidem, zopiclona y zaleplon (medicamentos Z).
Some medications, such as triazolam (Halcion[R]) and zaleplon (Sonata[R]), only help you fall asleep, while drugs such as eszopiclone, suvorexant and extended-release zolpidem help you fall asleep and stay asleep.