From the Guidelines
The maximum recommended dose of zolpidem (Ambien) for adults is 10 mg taken once daily immediately before bedtime. For immediate-release formulations, elderly patients or those with hepatic impairment should use a lower maximum dose of 5 mg. For extended-release formulations (Ambien CR), the maximum dose is 12.5 mg once daily before bedtime, with 6.25 mg recommended for elderly patients.
Key Considerations
- Zolpidem should be used for the shortest duration possible, typically 7-10 days, as it can cause dependence with prolonged use 1.
- The medication works by enhancing the effect of GABA, an inhibitory neurotransmitter in the brain that promotes sleep.
- Patients should take zolpidem only when they have a full 7-8 hours available for sleep to avoid next-day impairment.
- The medication takes effect quickly, usually within 30 minutes, so it should be taken immediately before getting into bed.
- Never increase the dose without medical supervision, as higher doses increase the risk of side effects including memory problems, sleepwalking, and respiratory depression 1.
Important Warnings
- The FDA recently released a safety announcement on the risk for serious injuries caused by sleep behaviors (sleepwalking, sleep driving, and other activities while not fully awake) associated with these agents 1.
- 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 1.
From the FDA Drug Label
The recommended initial dose of zolpidem tartrate for adult women is 5 mg, and the recommended dose for adult men is 5 or 10 mg. The dose of zolpidem tartrate in elderly patients is 5 mg to minimize adverse effects related to impaired motor and/or cognitive performance and unusual sensitivity to sedative/hypnotic drugs The recommended dose of zolpidem tartrate in patients with mild to moderate hepatic impairment is 5 mg once daily immediately before bedtime.
The maximum recommended dose of zolpidem for adults is 10 mg for men, and 5 mg for women, and for elderly patients, as well as those with mild to moderate hepatic impairment, the maximum dose is 5 mg 2.
- Key considerations:
- Dose should be individualized
- Lower doses may be necessary for some patients
- Geriatric patients and those with hepatic impairment should receive a lower dose to minimize adverse effects.
From the Research
Maximum Recommended Dose of Zolpidem
The maximum recommended dose of zolpidem for adults is not explicitly stated in the provided studies. However, the following information can be gathered:
- Zolpidem is a non-benzodiazepine hypnotic used as an adjunctive treatment for insomnia 3.
- The FDA has classified zolpidem as a category C drug based on adverse outcomes seen in animal fetal development 3.
- Women had a non-significantly higher mean plasma concentration than men after 8 hours for the 10mg IR and the 12.5mg MR 3.
- There is no mention of a maximum recommended dose in the provided studies, but it is known that zolpidem has a wide variety of adverse effects and has some special considerations noted in the literature 3.
Key Points to Consider
- Zolpidem is associated with an increased risk of falls, hip fractures, and complex behaviors such as sleepwalking and hallucinations 3.
- The relative risk for hip fractures in patients taking zolpidem was described as 1.92 (95% CI 1.65-2.24; P<0.001) 3.
- Zolpidem has been linked to suicide attempts and completion, with an odds ratio of 2.08 (95% CI 1.83-2.63) 3.
- Rebound insomnia has been a concern to prescribers of zolpidem, with sleep onset latency significantly increased on the first night after stopping zolpidem 3.
Alternative Treatments
- Cognitive-behavioral therapy for insomnia (CBT-i) is a non-pharmacological treatment that has been shown to be effective in improving sleep outcomes 4, 5, 6, 7.
- CBT-i is a multi-component treatment that targets difficulties with initiating and/or maintaining sleep and is delivered over the course of six to eight sessions 6.
- CBT-i has been shown to produce durable sleep improvements up to two years after completion of treatment 7.