From the FDA Drug Label
The following reactions did not meet this criterion but were reported by more atomoxetine-treated patients than placebo-treated patients and are possibly related to atomoxetine treatment: ... early morning awakening (terminal insomnia), ... insomnia (insomnia includes the terms, insomnia, initial insomnia, middle insomnia). The following adverse reactions occurred in at least 2% of child and adolescent CYP2D6 PM patients and were statistically significantly more frequent in PM patients compared with CYP2D6 EM patients: ... insomnia (11% of PMs, 6% of EMs); ... middle insomnia (3% of PMs, 1% of EMs); ... early morning awakening (2% of PMs, 1% of EMs); Among atomoxetine hydrochloride-treated patients, insomnia (0.9%, N=5)
Atomoxetine may interfere with sleep. Key points include:
- Insomnia was reported in atomoxetine-treated patients
- Early morning awakening and middle insomnia were also reported
- These sleep-related adverse reactions were more frequent in poor metabolizers compared to extensive metabolizers 1
From the Research
Atomoxetine is generally considered to be sleep neutral, and it may be a better option for patients with attention-deficit/hyperactivity disorder (ADHD) who experience sleep disturbances with stimulant medications. While some individuals may experience insomnia as a side effect of atomoxetine, others may not notice any sleep disturbances 2. The effects of atomoxetine on sleep vary from person to person, and it is typically taken once daily in the morning to minimize potential sleep disruptions. Starting doses of 40mg for adults and weight-based dosing for children are recommended, with gradual increases as needed. If sleep problems occur, several strategies may help, including taking the medication earlier in the day, practicing good sleep hygiene, avoiding caffeine in the afternoon, and establishing a consistent bedtime routine. Unlike stimulant ADHD medications, atomoxetine works by increasing norepinephrine levels in the brain rather than affecting dopamine, which explains its different side effect profile. According to a study published in 2018, atomoxetine appeared to be sleep neutral, with no significant differences in sleep quality compared to placebo 3. Another study published in 2017 found that insomnia was reported in 10-17% of subjects taking atomoxetine, although this may be related to poor metabolizer status 2. Overall, atomoxetine may be a good option for patients with ADHD who experience sleep disturbances with other medications, and its effects on sleep should be monitored and managed as needed.
Some key points to consider when prescribing atomoxetine include:
- Starting with a low dose and gradually increasing as needed to minimize potential side effects
- Taking the medication in the morning to minimize sleep disruptions
- Encouraging good sleep hygiene practices, such as avoiding caffeine and establishing a consistent bedtime routine
- Monitoring for potential side effects, including insomnia, and adjusting the dosage or timing of the medication as needed
- Considering alternative medications, such as agomelatine, if atomoxetine is not effective or is associated with significant side effects 4.
It's also important to note that atomoxetine has a different mechanism of action compared to stimulant medications, and it may be a better option for patients who experience adverse effects with stimulants 5, 6.