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Do not use on babies and children

According to company materials, the company describes its manufacturing as occurring in FDA-registered, GMP-certified facilities in the United States, adhering to what the company characterizes as pharmaceutical-grade production standards even for dietary supplements

Relevant clinical trials should assess outcomes such as sleep-onset latency, total sleep time, wakefulness after sleep onset, sleep efficiency, daytime functioning and patient-reported symptoms

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Many people obtain prescriptions through telehealth platforms that partner with compounding pharmacies