Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults

This randomized, parallel-group, participant-blinded, placebo-controlled trial enrolled 154 adults aged 60 years or older with insomnia. Participants were allocated in a 1:1 ratio using a computer-generated random-number table and sequentially numbered, sealed, opaque envelopes.

The active intervention was a 100-gram Traditional Chinese Medicine herbal sachet containing 10 powdered herbal ingredients. The formula was derived from an earlier expert-consensus development study. The placebo sachet contained five ingredients not expected to improve sleep and was designed to resemble the active sachet in size, weight, appearance, and texture.

Participants placed the assigned sachet within 30 centimeters of the head from 7:00 p.m. until 8:00 a.m. each night for eight weeks. Sachets were replaced every two weeks and stored in sealed bags during the daytime. Both groups received the same routine sleep-related education and support.

Insomnia symptoms and sleep quality were assessed at baseline, week 4, and week 8 using the Athens Insomnia Scale and Pittsburgh Sleep Quality Index. Adverse reactions, including allergic reactions and respiratory discomfort, were monitored throughout the intervention. The completed study was registered retrospectively.

Inclusion criteria

• Age 60 years or older.
• Athens Insomnia Scale (AIS) total score of 6 or higher.
• In generally good health or with a stable medical condition, with no major surgery, emergency event, or serious trauma during the previous 6 months.
• Able to remain at the same residential location throughout the study.
• No severe psychiatric disorder or cognitive impairment; able to read, write, and understand the study information; willing to participate and provide written informed consent.

Exclusion criteria

• Olfactory impairment or known allergy to any ingredient in the herbal or placebo sachets.
• Use of sedative-hypnotic medication, antipsychotic medication, Chinese herbal medicine, or proprietary Chinese medicine affecting sleep during the previous 2 weeks.
• Major medical or psychiatric illness, including severe cardiovascular or cerebrovascular disease, severe respiratory depression, or impaired liver or kidney function.