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Common Trade Names: Sonata

Other Names: N-[3-(3-cyanopyrazolo[1,5-a]pyrimidin-7-yl)phenyl]-N-ethylacetamide

Zaleplon is a Schedule IV medication indicated for the short-term treatment of insomnia. It is a sedative-hypnotic that is structurally different from other drugs carrying the same properties, such as benzodiazepines and barbiturates. While Schedule IV medications such as zaleplon are not considered habit-forming, chronic abuse and misuse of zaleplon may lead to substance use disorder.

A Brief History of Zaleplon

Zaleplon was first introduced as a prescription-only medication in 1999. In the same year, it was approved by the US FDA for the short-term treatment of insomnia. Zaleplon has been exclusively marketed by King Pharmaceuticals, a subsidiary of Pfizer based in Tennessee, and has used the brand name Sonata since its development. Currently, various manufacturers all over the world produce zaleplon generically.

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How Does Zaleplon Work in the Human Body?

Zaleplon is a sedative-hypnotic medication that is chemically unrelated to barbiturates, benzodiazepines, and other sedative-hypnotic drugs. Zaleplon works by interacting with gamma-aminobutyric-benzodiazepine (GABA-BZ) receptor complexes within the central nervous system (CNS). By activating these receptors, zaleplon initiates a cascade of events, beginning with the modulation of the chloride channel macromolecular complexes associated with GABA-BZ receptors. This increases the frequency of the opening of chloride channels, leading to the hyperpolarization of the cell membrane and an increase in the threshold of neuronal excitation, thereby potentiating the effects of gamma-aminobutyric acid (GABA), the major inhibitory neurotransmitter. This series of events is responsible for zaleplon’s sedative properties.

Zaleplon has US FDA approval for the short-term treatment of insomnia. Controlled clinical studies have demonstrated that zaleplon can decrease sleep latency – that is, the time between being fully awake and falling asleep – for up to 30 days from the start of therapy. The only absolute contraindication for the use of zaleplon is known allergic or hypersensitivity to it or to any component of its formulation.

How Is Zaleplon Taken or Administered?

Zaleplon is available in 5mg and 10mg capsules. In general, the recommended dose of zaleplon in adults is 10mg. However, for particular groups such as those with low body weight, elderly patients, and patients who are ill, a dose of 5mg may be adequate. Patients who do not show significant clinical improvement after a trial of a lower dose may require a total daily dose of 20mg, and this has been shown to be well-tolerated.

Patients with hepatic insufficiency have impaired drug clearance, and so a maximum daily dose of 5mg must be used in these patients to avoid toxicity. The same is true for patients taking cimetidine. On the other hand, dose adjustments may not be necessary for patients with renal impairment.

Zaleplon must be taken immediately before bedtime, or when the patient is experiencing trouble falling asleep at night. If possible, zaleplon should be taken on an empty stomach, as studies have shown that taking zaleplon after a heavy meal results in slower absorption which decreases its benefits on sleep latency.

Use of zaleplon is meant for short-term treatment of insomnia and is usually prescribed for a duration between two and four weeks. If no improvement is observed after this period, patients are usually prescribed a different medication for their insomnia.

What Are the Immediate and Long-Term Effects of Zaleplon Use?

Zaleplon produces a variety of side effects ranging from mild to moderate and manifesting in different organ systems. The following are the most common side effects associated with zaleplon:

General: Fever, chest pain, back pain
Dermatologic: Rash, itchiness
Cardiovascular: Migraine
Respiratory: Bronchitis
Gastrointestinal: Dry mouth, constipation, indigestion
Musculoskeletal: Muscle and joint pain, arthritis
Neurologic: Anxiety, depression, nervousness

Less frequently, zaleplon may produce the following side effects:

General: Edema, chills, neck rigidity
Dermatologic: Acne, balding, dry skin, eczema, increased sweating, skin discoloration
Cardiovascular: Blood pressure instability, palpitation, syncope, increased heart rate, cyanosis, postural hypotension
Respiratory: Asthma, difficulty in breathing, snoring, changes in voice
Gastrointestinal: Flatulence, gingivitis, increase in appetite, mouth ulcerations, aphthous stomatitis, dysphagia, increased salivation, tongue discoloration
Urogenital: Bladder pain, dysuria, hematuria, urinary frequency, urinary incontinence, urinary urgency, urinary retention
Endocrine: Hypothyroidism, goiter
Hematologic: Anemia, lymphadenopathy
Metabolic: Hypercholesterolemia, lactose intolerance, hypoglycemia, weight loss
Neurologic: Gait abnormality, agitation, body incoordination, euphoria, insomnia, sleep talking and walking, slurred speech

Sleep disturbances may be the only manifestation of a primary medical or psychiatric disorder. As such, the failure of insomnia to improve after the prescribed s of zaleplon therapy might indicate the presence of another condition. In addition, the aggravation of insomnia can be a result of an unknown, underlying psychiatric or medical disorder.

Other adverse effects that may be caused by zaleplon are behavioral changes and abnormal thinking. In most cases, this is characterized by decreased inhibition, extroversion, aggressiveness, agitation, hallucinations, and depersonalization. These symptoms are similar to those produced by other CNS depressants and alcohol.

Overdose of zaleplon may produce the following signs and symptoms:

  • Drowsiness
  • Lethargy
  • Confusion
  • Loss of consciousness
  • Impaired body coordination
  • Hypotension
  • Decreased muscle tone
  • Respiratory depression
  • Coma

Signs of Zaleplon Use Disorder

Under the Controlled Substances Act of the Drug Enforcement Agency, zaleplon is a Schedule IV medication. While Schedule IV medications are less addictive than Schedule II and III medications, they are also available only by prescription because they still carry a significant abuse potential particularly in patients with a history of substance abuse or those who chronically misuse zaleplon.
The Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) lists 11 Criteria for Substance Use Disorders (SUD). It has classified them into four major categories of pathologic behavior associated with zaleplon use disorder into :

  1. Impaired control
  2. Social impairment
  3. Risky use
  4. Pharmacological indicators (tolerance and withdrawal)

Listed below are the 11 criteria necessary for the clinical diagnosis of zaleplon use disorder:

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Impaired Control

  1. Taking zaleplon in higher doses or for a longer time than prescribed
  2. Not being able to stop using zaleplon despite many attempts
  3. Spending a lot of time trying to get, use, or recover from zaleplon
  4. Feeling intense, relentless cravings for or urges to use zaleplon

Social Impairment

  1. Zaleplon use impairs one’s ability to fulfill personal, social, and family obligations
  2. Zaleplon use causes problems in interpersonal relationships
  3. Zaleplon use causes one to absent themselves from important social and recreational activities

Risky Use

  1. Continued use of zaleplon despite being in the middle of a high-risk situation, such as while operating heavy machinery
  2. Continued use of zaleplon despite aggravation of existing medical conditions

Physical Tolerance

  1. The individual would require higher doses of zaleplon to achieve or maintain its desired effects (tolerance)
  2. The individual would start to develop withdrawal symptoms immediately after abrupt termination of zaleplon use (withdrawal)

Rehab and Treatment for Zaleplon Use Disorder

Just like other substance use disorders, addiction to zaleplon is highly treatable. In general, the treatment for zaleplon addiction begins with the detoxification process, in which the patient undergoes a series of medical and non-medical interventions to help eliminate the toxic substance that has damaged the body through chronic misuse. The ultimate objective of this is to achieve a substance-free state for the patient.

At this time, there is no specific drug indicated for the treatment of zaleplon use disorder, so the most common approach to detoxification is weaning-off or gradual discontinuation. This is where the doses of zaleplon would be tapered off over a period of several weeks to reverse the patient’s tolerance to the drug. Doing this will also prevent the development of withdrawal symptoms, which most patients experience after abrupt cessation of drug use. There is also what is called “drug replacement therapy.” It refers to the substitution of the substance on which the individual is dependent (in this case, zaleplon) with another drug that has the same efficacy but is not as addictive.

Non-medical interventions, on the other hand, include counselling, motivational interviewing, and group and family therapy. These are psychosocial and behavioral programs that aim to help the patient remain drug-free by teaching them ways to overcome their relapse triggers in the right manner. These programs also provide the emotional support that patients would need as they undergo rehab.

Medical and non-medical interventions in drug rehab go hand-in-hand. Studies have shown that combination therapy that involves both approaches significantly increases recovery rates and reduces relapse episodes. This is because medical interventions address physical dependence, while non-medical interventions address psychological dependence.

Treatment programs for drug addiction may be enrolled in either on an outpatient or an inpatient basis. Patients who can guarantee compliance to therapy and those who exhibit mild symptoms may be suitable for outpatient rehab. In contrast, patients who may have a questionable level of compliance or those with severe symptoms must strongly consider undergoing inpatient or residential treatment.

There is no single treatment that is right for everyone. As such, each treatment program must be individualized to maximize its benefits. Before initiating any intervention, a comprehensive medical and psychiatric evaluation must be done to determine its appropriateness. This includes a complete history taking and physical examination, extensive laboratory work-ups, and imaging tests when deemed necessary.

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