Zaleplon (Sonata®)

This article provides a comprehensive overview of zaleplon, including its uses and indications, side effects, and interactions.

Key Takeaways:

• Zaleplon is a sedative-hypnotic medication for insomnia. It’s specifically used to help individuals who have trouble falling asleep.

• Zaleplon is primarily used for short-term. It may stop working effectively if you take it every night for several weeks or longer.

• There are many possible side effects of zaleplon, some of which can be severe. It also interacts with many substances, including potentially dangerous interactions with alcohol, benzodiazepines, and other CNS depressants.

Understanding Zaleplon

Zaleplon is a prescription sleep medication that belongs to a specific drug class called non-benzodiazepine sedative-hypnotics (also called “Z-drugs” for short). It is primarily used on a short-term basis to help individuals fall asleep. Zaleplon is a quick-acting medication with an elimination half-life of around 1 hour, which is why it’s primarily used for sleep onset rather than sleep maintenance. ^[1]

How Does it Work?

Insomnia has numerous possible causes, but it is generally believed to involve hyperarousal in the brain and nervous system. This state of hyperarousal and excitability makes it hard to fall asleep and may impair overall sleep quality.

Zaleplon works by increasing the effects of GABA in the brain. GABA is an inhibitory neurotransmitter that helps to slow down mental activity, which may in turn help with falling asleep. ^[1]

Unlike benzodiazepines, zaleplon and other Z-drugs do not produce muscle relaxation or anti-seizure effects, since they primarily affect the brain. ^[1]

Brand Names

The primary brand name of zaleplon is Sonata®.

What is Zaleplon Used For?

Zaleplon is approved for the short-term treatment of insomnia, particularly for individuals who have trouble falling asleep. Research has shown that zaleplon helps individuals fall asleep faster, including those with chronic insomnia. ^{[1] [2]}

Zaleplon typically starts to work within 15 to 30 minutes, but it also has a short elimination half-life of around one hour, so it does not help you stay asleep longer or decrease nightly awakenings. Thus, it is not used for individuals who primarily deal with trouble staying asleep, frequent awakenings, or early morning awakenings. ^{[1] [2]}

Off-Label Uses

Zaleplon may be used off-label to treat sleep disturbances within Alzheimer’s disease. This is typically only after other measures have failed.

Additionally, long-term treatment of insomnia may be considered an off-label use of zaleplon, given that it is only indicated for short-term sleep issues.

Zaleplon Side Effects

Zaleplon has several possible side effects. The most common side effects of zaleplon are: ^{[1] [2]}

• Drowsiness

• For some people, this may also occur the next day, not just at night

• Sedation

• Dizziness

• Diarrhea

• Grogginess

• Trouble concentrating

• “Pins and needles” feeling on skin

Other possible zaleplon side effects include: ^{[1] [2] [3] [4]}

• Lightheadedness

• Loss of appetite

• Vision problems

• Eye pain

• Noise sensitivity

• Distorted sense of smell

• Painful menstrual periods

• Ear pain

This list may not contain all possible side effects. Always consult your doctor as soon as possible if you notice any of these or other side effects.

Rare and Severe Side Effects

There are also several rare or less common side effects of zaleplon, some of which may be serious or even life-threatening. This includes the following: ^{[1] [2] [3] [4]}

• Abnormal changes in thoughts or behavior, such as:

• Aggression

• Confusion

• Agitation

• Hallucinations

• Worsening depression

• Suicidal thoughts or actions

• Uncharacteristically outgoing or extroverted behavior

• CNS Depression: This risk is increased when combined with other CNS depressants. Symptoms include:

• Slow or shallow breathing

• Dizziness

• Feeling faint

• Shortness of breath

• Confusion

• Memory loss or memory impairments

• Anxiety

• Severe allergic reactions/anaphylaxis. Symptoms include:

• Swelling of the face, throat, tongue, mouth, or eyes

• Rash

• Hives

• Trouble breathing or swallowing

• Nausea and vomiting

• Nightmares or night terrors

Some people taking zaleplon also engage in behaviors during sleep, such as driving, talking on the phone, preparing and eating food, and having sex. These activities (which are termed “complex sleep behaviors”) pose a danger to oneself and others. Individuals have no recollection of these activities upon waking up the next day. ^{[1] [2]}

If any of these more serious side effects are noticed, report them to your doctor immediately.

Is it Addictive?

Zaleplon can be addictive, especially if it is misused, such as taking more than prescribed or combining it with other drugs. It is listed as a Schedule IV controlled substance under the Drug Enforcement Agency’s (DEA’s) Controlled Substance Act. ^[2]

It has similar abuse potential as benzodiazepines and non-benzodiazepine-like hypnotics. However, it has a relatively low risk of dependence, especially when used short-term as prescribed. ^[2]

Zaleplon Dosage

When used for insomnia, the typical zaleplon dosage recommendations are as follows: ^[1]

• Initial dose: 5 mg, immediately before bedtime

• Most common maintenance dose: 10 mg, taken immediately before bedtime

• Maximum dose: 20 mg, taken directly before bedtime

You should only take zaleplon when you’re ready to go to bed right away and can stay in bed for at least 4 hours.

Methods of Administration

Zaleplon is taken orally. It is formulated as oral capsules in strengths of 5 mg and 10 mg. ^[1]

Precautions

There are several precautions to consider with zaleplon. Specific caution is advised for use in the following populations: ^{[1] [2] [3]}

• Elderly: Zaleplon may cause more pronounced effects, which may impair motor and cognitive function and increase the risk of falls and injuries. Thus, a max dose of 5 mg is typically recommended.

• Individuals with liver impairment: Max dose should be 5 mg, due to lower clearance and drug metabolism abilities

• Individuals with depression: Use cautiously, particularly due to risk of worsening depression and suicidality.

Due to lack of established safety and/or specific risks, zaleplon is not recommended for: ^{[1] [2]}

• Pregnant and breastfeeding women

• Children

• Individuals with a history of complex sleep behaviors

• Individuals with a known hypersensitivity to zaleplon

• Individuals with a history of angioedema

Zaleplon also contains FD&C Yellow No.5 (tartrazine), which may cause allergic-like reactions in certain individuals. The most susceptible individuals are those with a known aspirin hypersensitivity. ^[2]

Zaleplon can cause drowsiness, impaired coordination, decreased alertness, and prolonged reaction time. This may increase the risk of falls and injuries. It may also affect your ability to drive, operate machinery, or perform complex tasks the next day, even if you feel fully alert. Do not perform these tasks until you know how zaleplon affects you and receive your doctor’s approval to do so. ^{[2] [3] [4]}

Harmful Interactions

There are several possible interactions with zaleplon. Firstly, zaleplon may interact with a variety of other medications and drugs that affect the CNS, such as: ^{[1] [2] [4]}

• Selective-serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine)

• Serotonin-norepinephrine reuptake inhibitors (SNRIs) (e.g. venlafaxine)

• Opioids (e.g. hydrocodone, oxycodone)

• Alcohol

• Tricyclic antidepressants (e.g. imipramine)

• Antipsychotics (e.g. thioridazine)

• Benzodiazepines (e.g. alprazolam, clonazepam)

• Other Z-drugs (e.g. zolpidem, eszopiclone)

• Anti-seizure medications (e.g. carbamazepine, phenytoin)

• Barbiturates (e.g. phenobarbital)

Of particular concern is when zaleplon is combined with other CNS depressants, such as benzodiazepines, other Z-drugs, opioids, and alcohol. Combining zaleplon with any of these substances increases the risk of respiratory depression, severe sedation, and dizziness, as well as complex sleep behaviors. In severe cases, it can lead to coma or death. ^[2]

Zaleplon may also interact negatively with: ^{[2] [4]}

• Antifungals (e.g. ketoconazole, itraconazole)

• Antibiotics (e.g. erythromycin, rifampin)

• Antacids (e.g. cimetidine)

This list does not contain all possible interactions. Always tell your doctor everything you take or have taken in the past, including prescription and over-the-counter medicines, vitamins, herbs, and supplements.

Safe Storage

It’s important to keep zaleplon tightly closed in the original container it came in, and out of the reach of children. Store it at room temperature, away from excess heat and moisture (e.g. not in the bathroom). ^[4]