What are the guidelines for using Ambien (zolpidem) for insomnia?

Guidelines for Using Ambien (Zolpidem) for Insomnia

Zolpidem is recommended as a treatment for both sleep onset and sleep maintenance insomnia in adults, with a weak recommendation strength according to the American Academy of Sleep Medicine. 1

Dosage Recommendations

• Standard dosing:

  • Adults: 10mg immediate-release (though FDA has subsequently lowered recommended starting dose to 5mg) 1
  • Elderly: 5mg immediate-release 1, 2
  • Extended-release: 12.5mg (FDA subsequently lowered to 6.25mg) 1

• Duration of treatment:

  • Indicated for short-term treatment (≤4 weeks) of insomnia 3
  • Clinical trials supporting efficacy were 4-5 weeks in duration 3

Efficacy

Zolpidem has demonstrated efficacy in:

• Sleep onset insomnia:

  • Mean reduction in sleep latency of approximately 29 minutes compared to placebo 1
  • Decreases sleep latency for up to 35 days in controlled clinical studies 3

• Sleep maintenance insomnia:

  • Mean reduction in wake after sleep onset (WASO) of 25 minutes compared to placebo 1
  • Moderate improvement in sleep quality compared to placebo 1, 4
  • Mean improvement in total sleep time of 29 minutes compared to placebo 1

Administration Considerations

• Administer 30-60 minutes before desired sleep time 4
• Can be used intermittently (3-5 nights per week) without evidence of rebound insomnia or increased frequency of use over time 5
• Schedule follow-up within 2-4 weeks to assess effectiveness and side effects 4

Adverse Effects and Safety Considerations

• Common side effects:

  • Amnesia, dizziness, and somnolence 1, 2
  • Daytime sleepiness, confusion (particularly in elderly) 2

• Serious concerns:

  • Increased risk of falls (OR 4.28) and hip fractures (RR 1.92) 2
  • Complex behaviors: sleepwalking, sleep-driving, and other activities while not fully awake 2
  • Potential for suicide attempts (OR 2.08) 2
  • Withdrawal seizures (rare, typically with high doses) 2
  • Rebound insomnia possible upon discontinuation 2

• Special populations:

  • Women have higher plasma concentrations than men after 8 hours 2
  • Pregnancy: Category C drug with increased risk of low birth weight, preterm delivery, and small for gestational age babies 2
  • Hepatic impairment: Use lower doses 6

Place in Therapy

• First-line therapy: Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as first-line treatment for chronic insomnia 4

• Pharmacological options:

  • Zolpidem is appropriate for both sleep onset and maintenance insomnia 1, 4
  • Other options include:
    • Sleep onset insomnia: Zaleplon, Ramelteon 4
    • Sleep maintenance insomnia: Doxepin (3-6mg), Eszopiclone (2-3mg), Suvorexant (10-20mg) 4

• Not recommended:

  • Diphenhydramine is not recommended for treating insomnia 1
  • Melatonin is not recommended for treating insomnia 1
  • Trazodone is not recommended for treating insomnia 1

Monitoring and Follow-up

• Monitor for next-day residual effects, particularly in elderly patients 2
• Assess for development of tolerance, though clinical studies up to 6 months showed no evidence of tolerance developing 6
• Evaluate for rebound insomnia upon discontinuation, though most evidence suggests minimal rebound when used as directed 7

Clinical Pearls

• Zolpidem has minimal next-day effects on cognition and psychomotor performance when administered at bedtime as directed 6
• Lower doses should be used in elderly patients due to slower drug metabolism 2
• Zolpidem has a lower incidence of residual daytime sleepiness compared to other hypnotics 2
• Decisions to prescribe should be made on a case-by-case basis, weighing risks of insomnia against potential adverse effects 2