SUMAYYA
17 September 2022
Medically reviewed by
Kajal Jain
M. Pharm
zolpidem-for-insomnia
Table of Contents

Insomnia is a subjective symptom of poor or non-restorative sleep, difficulty falling asleep or staying asleep at night, and waking up in the middle of the night or too early in the morning. It has been estimated that 25% of adults do not get enough sleep, 10–15% report insomnia accompanied by daytime problems, and 6–10% present insomnia symptoms.

Several medications are used to treat insomnia, including over-the-counter sleep aids, prescription hypnotic medications, and other medications that are not explicitly prescribed for the condition. An imidazopyridine derivative, Zolpidem, is used worldwide for treating insomnia. The conventional immediate-release (IR) tablet formulation of Zolpidem was initially authorized for clinical usage in the US. In April 2007, generic Zolpidem received approval.

Taking Zolpidem helps patients with insomnia sleep better. Zolpidem does not generally change the structure of sleep. It is generally well tolerated, including in elderly patients. This section explores the use of Zolpidem, including "as required" treatment, in patients with insomnia.

What Is Ambien (Zolpidem)?

Zolpidem is an imidazopyridine compound that acts by enhancing GABAA receptor function. It improves the total sleep time and efficiency of sleep while decreasing sleep latency and nocturnal awakening frequency.

Zolpidem is a federally controlled substance (C-IV), and you should have a prescription to buy Zolpidem online or from a local drug store and should be used under the supervision of a doctor. 

Indications And dose

Indications:

It enhances measures of sleep latency, sleep duration, and the frequency of awakenings in patients with transient insomnia.
It helps people with chronic insomnia sleep better and has a minor muscle-relaxing effect.
Indicated for Anxiety, migraine, and neurological conditions. 

Dose:

The initial doses for women and men are different because zolpidem clearance is lower in women. There were incidences of increased residual impairment and adverse events. Therefore, treatment with Zolpidem should be as short as possible.

Zolpidem comes in sublingual, normal-release, extended-release, and oral spray dosage forms.
The initial dose is 6.25 mg for women and either 6.25 or 12.5 mg for men.

Take the medication once per night, right before bed, at least 7-8 hours before the intended time of awakening. The total dose of Extended-Release Tablets should not exceed 12.5 mg once daily, immediately before bedtime.

What Is Insomnia?

Insomnia is defined as a complaint of difficulty falling asleep or staying asleep that is related to daytime consequences and is not attributable to environmental circumstances or inadequate opportunity to sleep.

Chronic insomnia continues for at least three months with a frequency of at least three times per week. Short-term insomnia is a disorder that fits the symptom criteria but has lasted less than three months. 

Statistics And Facts About Insomnia

According to the American Academy of Sleep Medicine (AASM), adult insomnia can cause:

  • Transient insomnia symptoms affect 30 to 35 percent of people.
  • 15 to 20% of people have short-term insomnia.
  • 10% of people have chronic insomnia, which affects them at least three times per week for at least three months.

A review paper published in 2019 reported that up to 75% of people aged 65 and older report having insomnia symptoms.

Symptoms Of Insomnia     

  • Difficulty falling asleep  
  • Difficulty returning to sleep.
  • Gastrointestinal symptoms
  • Low motivation or energy
  • Headache
  • Difficulty socializing, working or studying
  • Feeling tired during the daytime.
  • Irritability, depression, or Anxiety
  • Problems with concentration or memory

How Does Zolpidem Work In Insomnia?

Zolpidem is an imidazopyridine non-benzodiazepine hypnotic. It binds to specific receptors of the GABA-responsible for the modulation of the chloride channels.

Zolpidem works as a gamma-aminobutyric acid (GABA), a receptor chloride channel modulator/agonist that increases GABA inhibitory effects, leading to sedation. It activates these receptors, resulting in sedative effects that help maintain deep sleep.

Studies Related To Zolpidem Use In Insomnia

  1.     A study by Allain and colleagues evaluated zolpidem 10 mg administered on an as-needed basis over four weeks. Zolpidem produced a statistical increase in subjective Total Sleep Time versus placebo.
  2.      A Study: Perlis evaluated 199 subjects with primary insomnia on a 10 mg or placebo of Zolpidem. The frequency of medication was 3–5 times per week as needed over twelve weeks. Sleep diary outcomes included Sleep Latency, Total Sleep Time, Week After Sleep Onset (min), and the Number of Awakenings.
  3.      In the study conducted by Roth with zolpidem ER 12.5 mg, Sleep Efficiency was 3.9% better with Zolpidem than with a placebo. 

Side Effects of Zolpidem

The GABA-BZ agonist effects of Zolpidem typically have predictable side effects. Patients who take Zolpidem before bedtime and then wake up in the middle of the night run the risk of experiencing ataxia, performance problems, slow reaction times, and amnesia.

  • Anxiety     
  • Depression
  • Aggression
  • Agitation
  • Confusion
  • Hallucinations
  • Memory problems
  • Suicidal thoughts
  • Lightheadedness
 

Precautions You Should Take 

When using drugs, you must take measures before giving them to a patient. Call your pharmacist if you have any queries regarding your prescriptions or Safety worries.
 

Before you take Ambien:

  • Take Ambien only as prescribed by your doctor.
  • Inform your doctor of all your medical and medication history.
  • Take Zolpidem just before bedtime to ensure you get 7-8 hours of unbroken sleep.
    Completely swallow the extended-release tablet of Zolpidem. Do not split, chew, or smash it.
  • Take Zolpidem without food. This medication might not work as effectively if taken with food or after a meal.
  • Avoid driving and hazardous activities after intake of Zolpidem.
    Do not take Zolpidem if you have had alcohol the same evening or before bed.

Alternative Medications In The Management Of Insomnia

The American Academy of Sleep Medicine (AASM) guidelines suggest that improving sleep quality and addressing associated daytime impairments are therapeutic objectives.

The AASM recommendation promotes psychological and behavioral therapies, such as cognitive-behavioral therapy (CBT) in primary and chronic comorbid insomnia.

The first step in treating insomnia is educating patients about the issue and implementing the necessary sleep hygiene practices.

Treat Mental Illness If The Patient Has Any Symptoms.

If improper use of drugs is the cause of your sleeplessness, you must gradually taper off and stop using the offending substance. CBT includes the following:

  • Sleep Hygiene Education: Sleep hygiene Education addresses behaviors incompatible with sleep. These include caffeine or alcohol consumption, ambient noise, inappropriate room temperature, and watching TV in bed.
  • Cognitive therapy: The patient can correct misconceptions about sleep and reduce catastrophic thoughts and excessive worry about the consequences of inadequate sleep.
  • Relaxation therapy: The patient learns to recognize and control the tension by performing exercises that involve first tensing and then systematically relaxing each muscle group. Through guided imagery and meditation, the patient learns to focus on neutral or pleasant targets rather than racing thoughts.
  • Stimulus control therapy: Stimulus-control therapy entails actions you can take to reduce Anxiety and establish a positive relationship with your sleeping environment.
  • Sleep-restriction therapy: Restricts the time in bed to their estimated total sleep time and then gradually extends by 15 to 30 minutes each day for a given week once they feel that their sleep efficiency has increased to more than 85%.

Pharmacological Treatment of Insomnia

  • Sedative-hypnotic drugs: These medications can be a stand-alone treatment or an adjunct to CBT to relieve symptoms. Eszopiclone, Zolpidem, and zaleplon are examples of non-benzodiazepine receptor agonists that are thought to be less habit-forming than benzodiazepines and hence offer significant advancements in the long-term management of chronic insomnia.
    • Non-benzodiazepine receptor agonists are best used with nonpharmacological treatments to treat temporary and short-term insomnia.
  • Orexin inhibitors: Suvorexant, the first orexin receptor antagonist for insomnia, received FDA approval in August 2014. It treats insomnia marked by difficulties falling asleep or staying asleep.
    • The FDA authorized Lemborexant, a second orexin inhibitor, in December 2019 for managing the onset of sleep and sleep maintenance.
    • Daridorexant is a dual orexin receptor antagonist that prevents the binding of neuropeptide orexins, OX1R and OX2R, reducing excessive vigilance. The FDA authorized daridorexant in January 2022 for adult insomnia.
  • Ramelteon: The FDA approved using the Melatonin receptor agonist ramelteon in patients with insomnia. Patients with sleep-onset insomnia should take this drug, especially older patients with gait problems who are more likely to fall and those with a history of substance addiction.
  • Antidepressants: Sedating tricyclic antidepressants have been utilized, including amitriptyline, nortriptyline doxepin, and the tetracyclic medication mirtazapine.
  • Antihistamines: The main component of over-the-counter (OTC) sleep aids is antihistamines.
  • Melatonin: Melatonin is a popular over-the-counter sleep medication. It is a hormone that the pineal gland naturally secretes. 

Bottom Line From Practical Anxiety Solutionss

The selection of a medication for the treatment of insomnia should be based on the drug's pharmacological properties and clinical aspects specific to the patient. Clinical trials have shown sufficient data to support CBT and authorized hypnotic medications as treatment options for insomnia.

Zolpidem is a non-benzodiazepine compound that acts by enhancing GABAA receptor function. Global efficacy ratings indicate that Zolpidem is typically also effective when used "as needed" on patients with insomnia.

In conclusion, Zolpidem helps patients with insomnia sleep better. When used by the doctor's instructions for usage, it is generally well tolerated and has a lower propensity to result in clinically significant side effects, withdrawal symptoms, or performance issues than partial insufficient sleep dependency or tolerance. In contrast to conventional benzodiazepines, Zolpidem has a higher safety profile and appears to be a promising novel hypnotic for insomnia. 

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