What is the recommended duration of treatment with zaleplon (a non-benzodiazepine hypnotic agent) for insomnia?

Zaleplon Treatment Duration

Zaleplon is indicated for short-term treatment of insomnia, specifically 2-4 weeks, with FDA approval supporting use up to 30 days maximum. 1, 2

FDA-Approved Duration

• The FDA label explicitly states zaleplon is indicated for "short-term treatment of insomnia" with efficacy demonstrated for up to 30 days in controlled clinical studies. 1
• Clinical trials supporting zaleplon's efficacy ranged from single-night use to 5 weeks in duration, with formal assessments conducted at the end of treatment. 1

Guideline Recommendations

• The American Academy of Sleep Medicine recommends using zaleplon for the shortest duration possible, typically 2-4 weeks. 3
• Treatment should utilize the lowest effective dose (10 mg for non-elderly adults, 5 mg for elderly patients) for this limited timeframe. 3, 4

Evidence for Extended Use

• Studies evaluating zaleplon for 5 weeks showed that tolerance to hypnotic effects generally did not develop during this treatment period. 5, 2
• Limited data from abstracts suggest no tolerance development during longer-term treatment (6-12 months), though these represent lower-quality evidence not included in formal guideline recommendations. 2
• No significant withdrawal symptoms or rebound insomnia were observed after discontinuation of zaleplon at recommended doses for the recommended treatment duration. 3, 6, 2

Clinical Context and Limitations

• Zaleplon's efficacy is primarily limited to sleep onset insomnia, with minimal effects on sleep maintenance parameters. 3, 4, 7
• The medication shows modest improvements in total sleep time (approximately 21.5 minutes) that are not consistently significant compared to placebo. 4
• Cognitive behavioral therapy for insomnia (CBT-I) should be considered as first-line treatment or in combination with pharmacotherapy rather than relying on extended medication use. 3

Practical Application

• For patients requiring treatment beyond 4 weeks, reassess the underlying cause of insomnia and consider alternative approaches including CBT-I. 3
• The ultra-short half-life (approximately 1 hour) makes zaleplon suitable for as-needed use within the 2-4 week treatment window, including middle-of-night dosing if ≥4 hours remain before awakening. 3, 8