Zaleplon

Medically Reviewed by Dr. Harshi Dhingra, M.D.

Last Reviewed: Jan 10, 2025

Warnings


Zaleplon Risks, Warnings, and Complications


Zaleplon can cause or worsen health problems in some people. Talk to your doctor or pharmacist about other medications for insomnia if you are at an increased risk of adverse reactions from this drug. Some of the risks of taking zaleplon include:

  • ABUSE, MISUSE, AND ADDICTION: Zaleplon is a Schedule IV federally controlled substance due to the risk of abuse, addiction, withdrawal symptoms, and tolerance. 

    Zaleplon abuse means using the drug for non-medical purposes or with other psychoactive substances. You can develop addiction (a physical dependence on zaleplon), characterized by withdrawal symptoms if you stop taking it suddenly or reduce the dose rapidly. Withdrawal symptoms may include rebound insomnia, stomach cramps, vomiting, muscle cramps, sweating, shakiness, and convulsions. Tolerance is when you need larger doses of zaleplon over time to get the same drug effects. 

    Do not change the dose, dosing frequency, or treatment duration with zaleplon without your doctor’s approval.

  • COMPLEX SLEEP BEHAVIORS: People taking zaleplon may experience complex sleep behaviors such as sleepwalking or doing other activities while not fully awake, such as sleep-driving, cooking, making phone calls, and having sex, without any recall of the events the next day. These complex sleep behaviors can lead to serious injuries and potentially fatal accidents. The effects can occur at the usual recommended doses of zaleplon alone or with concomitant use of alcohol and other central nervous system (CNS) depressants. Tell your doctor without delay if your family members report sleepwalking or any unusual sleep behaviors.

  • NEXT DAY IMPAIRMENT: Zaleplon and other sedative-hypnotics cause CNS depression. For this reason, the medication should be taken immediately before bedtime or after going to bed and not being able to fall asleep, provided you have 7-8 hours of sleep duration remaining. Getting out of bed too soon after taking zaleplon or taking it in the middle of the night can result in next-day impairments, including drowsiness, dizziness, lack of coordination, memory problems, and hallucinations (seeing or hearing things that aren’t actually there).

    Taking zaleplon with other CNS depressants such as alcohol, benzodiazepines, opioids, and certain antidepressants increases the risk of these side effects. Give your healthcare provider a full list of all your medications before starting zaleplon to avoid potentially dangerous interactions. You should not take zaleplon with other sedative-hypnotics (sleeping medications).

    Zaleplon can cause drowsiness, dizziness, blurred vision, double vision, reduced alertness, and slowed reaction times. Be careful while driving and doing other potentially hazardous activities until you know how it affects you. Elderly patients are at a higher risk of these side effects and are typically prescribed lower doses (zaleplon 5 mg) instead of the usual zaleplon 10 mg dose. 

  • COMORBID DIAGNOSES: Insomnia and other sleep disturbances can be signs of underlying physical health conditions or psychiatric disorders. Your doctor will prescribe zaleplon to treat insomnia after a careful evaluation to rule out underlying health conditions. They may refer you to a specialist in Sleep Medicine. Call your doctor if you have worsening insomnia or new mood or behavior changes after starting zaleplon therapy. 

  • SEVERE ALLERGIC REACTIONS: There are rare reports of severe allergic reactions, including anaphylaxis (throat closing) in patients who took zaleplon after the first or subsequent doses. Seek emergency medical care if you develop swelling of the mouth or throat, difficulty breathing, hoarseness, or chest tightness after taking this medicine.

  • THINKING AND BEHAVIOR CHANGES: Treatment with sedative-hypnotic drugs can lead to abnormal thinking and behavior alterations, such as decreased inhibitions, and personality changes (increased aggression, extroverted behaviors), similar to alcohol intoxication and other drugs that cause CNS depression. Seek immediate medical care for any reported bizarre behaviors, confusion, agitation, hallucinations, or personality changes. 

  • WITHDRAWAL SYMPTOMS: Stopping zaleplon suddenly or rapidly reducing the dose can cause withdrawal effects similar to other CNS-depressant drugs. Talk to your doctor before you stop taking zaleplon.


Precautions Before Starting Zaleplon

Tell your doctor if you have ever had an allergic reaction to zaleplon, any of the active or inactive ingredients in zaleplon capsules, other sleep medications, tartrazine yellow dye, or any other drugs. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of your medications, including prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products. This can help avoid possible interactions between zaleplon and your other medicines.

Give your doctor a complete medical history. Zaleplon may not be safe for people with certain medical conditions such as alcohol, prescription drugs, street drug abuse,  mental illness or suicidal thinking or behaviors, seizure disorders, lung disease, severe renal impairment (kidney disease), and liver disease.

Talk with your health care provider about the benefits versus risks of taking zaleplon if you are 65 years of age or older. There may be other safer sleep medications available for older adults. 

Tell your doctor if you are pregnant, could be pregnant, plan to get pregnant, or are breast-feeding.

Precautions During Use of Zaleplon

Keep all your medical and lab appointments while on zaleplon. Call your doctor if you do not notice an improvement in your insomnia after 7-10 days of treatment with zaleplon. You should know that zaleplon can reduce sleep latency (time taken to fall asleep), but it does not affect sleep duration or the number of nighttime awakenings. 

Avoid heavy meals before taking zaleplon. Eating food that is fatty or greasy can affect the absorption of zaleplon and make it less effective.

Zaleplon can cause drowsiness, dizziness, reduced mental alertness, slowed reaction time, coordination problems, and vision changes the next day, which can increase the risk of falls and injuries. Be careful if you get out of bed during the night. Do not drive or do other hazardous activities until you know how zaleplon affects psychomotor performance. 

Do not drink alcohol while on zaleplon. Alcohol has CNS-depressant effects and can make the side effects of zaleplon worse.

Tell your doctor right away if you or members of your household report any mental health changes or unexpected behaviors such as unusual aggressiveness, personality changes like being more outgoing, hallucinations, out-of-body sensations, new or worsening depression, memory problems, suicidal thoughts or behaviors, or other mood changes. Also, promptly report any complex sleep behaviors, such as sleepwalking, to your physician. Your family members should know when and how to seek care if you cannot do so yourself. 

Tell your doctor if you become pregnant while on zaleplon.

Tell all your healthcare providers you are on zaleplon before any surgery, including dental procedures.

Zaleplon Drug Interactions

Concomitant use of certain medicines with zaleplon can affect how the medicines work and increase the risk of severe adverse effects. Some of the medications that can interact with zaleplon include:

  • Tricyclic antidepressants such as imipramine
  • Selective serotonin reuptake inhibitors (SSRIs) such as paroxetine
  • Selective serotonin-norepinephrine reuptake inhibitors (SNRIs) such as venlafaxine
  • Antihistamines such as promethazine and diphenhydramine
  • Antipsychotic drugs such as thioridazine
  • Antitubercular drugs such as rifampin
  • Antiepileptic drugs such as carbamazepine, phenobarbital, and phenytoin
  • Certain antibiotics, such as erythromycin
  • Antifungal agents like ketoconazole
  • H2 blockers such as cimetidine 
  • Anticoagulants or blood thinners such as warfarin
  • Nonsteroidal anti-inflammatory drugs such as ibuprofen

The above list may not include all the potential drug interactions of zaleplon. Give your doctor or pharmacist a complete list of your medications, including prescription drugs, over-the-counter medicines, nutritional supplements, and herbal remedies. Also, tell your healthcare professional if you smoke, drink alcohol, or use illegal drugs because some of these substances can cause serious health complications when used with prescription medications.