What is the indication for Zolpidem (Ambien)?

From the Guidelines

Zolpidem (Ambien) is indicated for the treatment of insomnia, specifically for improving sleep onset and maintenance in adults with difficulty falling asleep or staying asleep.

Key Points

• The American Academy of Sleep Medicine clinical practice guideline found weak evidence of efficacy in the treatment of sleep onset and maintenance insomnia, with limited evidence of mild adverse events 1.
• Zolpidem has been shown to improve sleep onset latency and total sleep time in the general population, with moderate-quality evidence supporting its use 1.
• The American College of Physicians clinical practice guideline recommends that zolpidem be used at the lowest effective dose and for the shortest possible duration, with all patients counseled on potential risks 1.
• Common adverse events associated with zolpidem include amnesia, dizziness, sedation, headache, nausea, and taste perversion, although the risk of these events is generally considered low 1.
• Zolpidem should be used with caution in older adults, as it may increase the risk of falls and cognitive impairment 1.
• The FDA has released a safety announcement on the risk of serious injuries caused by sleep behaviors associated with zolpidem, including sleepwalking, sleep driving, and other activities while not fully awake 1.

From the FDA Drug Label

Zolpidem tartrate tablets are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. The indication for Zolpidem (Ambien) is the short-term treatment of insomnia characterized by difficulties with sleep initiation 2.

• The treatment is intended for short-term use.
• The specific insomnia characteristic is difficulties with sleep initiation.

From the Research

Indication for Zolpidem (Ambien)

• Zolpidem is indicated for the short-term treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance 3, 4, 5, 6.
• The medication is approved for use in adults and the elderly, with recommended dosages of 10 mg/day in adults and 5 or 10 mg/day in the elderly or patients with hepatic impairment 6.
• Zolpidem is also available in extended-release formulations, which are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance 5.
• The sublingual forms of zolpidem are indicated for middle-of-the-night (MOTN) wakefulness and difficulty returning to sleep, while the oral spray is marketed for difficulty falling asleep 7.

Clinical Populations

• Zolpidem has been studied in several clinical populations, including:
  • Poor sleepers
  • Transient insomnia
  • Elderly and non-elderly patients with chronic primary insomnia
  • Comorbid insomnia 7
• The medication has been shown to be effective in improving sleep in patients with insomnia, with a low propensity to cause clinical residual effects, withdrawal, dependence, or tolerance 4, 6.

Dosage and Administration

• The recommended dosage of zolpidem is 10 mg/day in adults and 5 or 10 mg/day in the elderly or patients with hepatic impairment 6.
• The extended-release formulation is available in 6.25 mg and 12.5 mg doses, which are indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance 5.
• The sublingual forms of zolpidem are available in 5 mg and 10 mg doses, which are indicated for middle-of-the-night (MOTN) wakefulness and difficulty returning to sleep, and difficulty falling asleep, respectively 7.