Zolpidem (Ambien) Regulatory Status: US, EU, Canada, and UK Scheduling and Prescribing Rules

Is zolpidem a controlled substance in the United States?

Yes. The Ambien label states zolpidem is 'classified as a Schedule IV controlled substance by federal regulation' [1]. The label warns that use may lead to physical and psychological dependence, with risk rising with dose and duration [1].

What do the Ambien labels say about prescribing?

The indication is short-term treatment of insomnia with difficulty falling asleep; decreased sleep latency was shown for up to 35 days [1]. The label directs one dose only, immediately before bedtime, with at least 7 to 8 hours remaining before planned awakening, and no second dose that night [1]. The Ambien label says to use the lowest effective dose and keep treatment as short as possible, that persistent insomnia should be re-evaluated after 7 to 10 days, and that long-term use is not recommended [1]. Safety and effectiveness in pediatric patients have not been established; in a trial of children ages 6 to 17 with ADHD, 7% had hallucinations [1][2].

Why is the recommended US dose lower for women?

The label sets an initial dose of 5 mg for women and 5 or 10 mg for men; for Ambien CR, 6.25 mg for women and 6.25 or 12.5 mg for men, because zolpidem clearance is lower in women [1][2]. The maximum is 10 mg immediate-release or 12.5 mg extended-release once daily [1][2]. On 10 January 2013 the FDA announced it was requiring lower recommended doses because blood levels in some patients may be high enough the next morning to impair driving [3]. It cut the women's recommended dose from 10 mg to 5 mg for immediate-release products and from 12.5 mg to 6.25 mg for Ambien CR [3].

What changed with the 2019 boxed warning?

On 30 April 2019 the FDA announced a boxed warning for complex sleep behaviors across eszopiclone, zaleplon and zolpidem [4]. The label says these behaviors can occur after the first or any later dose, at recommended doses, with or without alcohol or other CNS depressants, and patients usually do not remember them [1]. Zolpidem is contraindicated in anyone who has had one after taking it [1].

What about the EU, Canada and the UK?

This page does not state scheduling or prescribing classifications for those markets. The rules above are US federal scheduling and the FDA labels for Ambien and Ambien CR [1][2].