What is the information about Ambien (Zolpidem)?

From the Guidelines

Ambien (zolpidem) is a prescription medication used for short-term treatment of insomnia, with a typical starting dose of 5mg for women and older adults or 5-10mg for men, taken once daily immediately before bedtime, and treatment should generally be limited to 7-10 days as prolonged use can lead to dependence and tolerance 1.

Key Points

• Ambien works by enhancing the effect of GABA, an inhibitory neurotransmitter in the brain that promotes sleep 2.
• Side effects may include drowsiness, dizziness, headache, and in some cases, complex sleep behaviors like sleepwalking or sleep-driving 3.
• Patients should take Ambien only when they have 7-8 hours available for sleep, avoid alcohol while using it, and discontinue use gradually rather than stopping abruptly 4.
• Those with respiratory conditions, history of substance abuse, or liver disease should use Ambien with caution 5.
• For chronic insomnia, cognitive behavioral therapy is generally preferred over long-term medication use 6.

Important Considerations

• The U.S. Food and Drug Administration recently released a safety announcement on the risk for serious injuries caused by sleep behaviors associated with nonbenzodiazepine BZRAs, including zolpidem 7.
• To minimize the incidence of adverse events, a nonbenzodiazepine BZRA, if prescribed, should be administered at the lowest effective dose and for the shortest possible duration, and all patients offered these agents should be counseled on the potential risks 8.
• The work group advised against use of benzodiazepines or trazodone for treatment of chronic insomnia disorder, due to the widely known harms and adverse effects of benzodiazepines, including risk for dependency and diversion, falls and cognitive impairment in older patients, hypoventilation in patients with respiratory conditions, and neuromuscular diseases 9.

From the FDA Drug Label

What is zolpidem tartrate? Zolpidem tartrate is a sedative-hypnotic (sleep) medicine Zolpidem tartrate is used in adults for the short-term treatment of a sleep problem called insomnia (trouble falling asleep).

Key Information about Ambien (Zolpidem):

• Indication: Zolpidem tartrate is used for the short-term treatment of insomnia in adults.
• Mechanism of Action: Zolpidem is a GABA A receptor positive modulator that exerts its therapeutic effects by binding to the benzodiazepine site of α1 subunit containing GABA A receptors.
• Dosage: The recommended dose for zolpidem tartrate should be 5 mg in the elderly [see WARNINGS AND PRECAUTIONS (5), DOSAGE AND ADMINISTRATION (2)].
• Contraindications: Do not take zolpidem tartrate if you are allergic to zolpidem or any other ingredients in zolpidem tartrate.
• Side Effects: Zolpidem tartrate may cause serious side effects, including complex sleep behaviors that have caused serious injury and death. 10

From the Research

Overview of Ambien (Zolpidem)

• Ambien, also known as Zolpidem, is a non-benzodiazepine hypnotic used for the short-term treatment of insomnia 11, 12, 13, 14.
• It is indicated for the treatment of insomnia characterized by difficulties with sleep initiation, sleep maintenance, or both 11, 14.

Efficacy and Safety

• Zolpidem has been shown to be effective in improving sleep in patients with insomnia, with a favorable tolerability profile when used according to the manufacturer's prescribing information 13, 14.
• The drug has a low propensity to cause clinical residual effects, withdrawal, dependence, or tolerance, and is associated with minimal rebound insomnia 13, 14.
• However, zolpidem has been linked to various adverse effects, including an increased risk of falls, hip fractures, and complex behaviors such as sleepwalking, hallucinations, and increased suicidality 11.

Pharmacology and Dosage

• Zolpidem is an imidazopyridine agent with a short plasma half-life and limited duration of action, making it suitable for the treatment of insomnia 12, 14.
• The recommended dosage is 10 mg/day in adults and 5 or 10 mg/day in the elderly or patients with hepatic impairment 14.
• Female patients may require smaller doses due to higher plasma concentrations of the drug 11.

Special Considerations

• Zolpidem should be used with caution in patients with a history of psychiatric illness, as it may exacerbate psychotic symptoms or induce new-onset psychosis 15.
• The drug is classified as a category C drug by the FDA, indicating that it may cause adverse outcomes in animal fetal development, and its use during pregnancy should be carefully considered 11.